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SKIN CAP Public Opinion

SKIN CAP

Skin-Cap spray is being heavily advertised in the lay press and I am
encountering patients on a daily to weekly basis asking about it.
Skin-Cap spray is produced in Madrid, Spain by the Cheminova Corporation.
It has been used in Europe for about 10 years without any significant
reported side effects. It is FDA registered in the U.S. to treat seborrheic
dermatitis and has been available in the U.S., via mail order, for about 1
year. I have tried it on about 30 patients and have achieved an
effectiveness rate of 100%, the majority with total clearing of their
plaques in 3-6 weeks.I have used it side by side in about 4 patients with
Dovonex and Temovate and it has been more effective than either one alone
or the two in combination! I have also used it in combination with PUVA,
etretinate, and methotrexate with excellent results. (It cleared the
remaining resistant plaques in several patients using methotrexate
without the need to increase the dose of MTX, in fact we are considering
reducing the dose of MTX!!!!!!). There have been rumors that the product
contains some form of steroid, but our chromotographic investigations
reveal no steroid peaks, and, as mentioned, it performs better than
Temovate. The listed ingredients are:([activated]zinc pyrithione, sodium
lauryl sulphate, isopropyl myristate, and propel 45 (propellant)).Of course,
I am a natural skeptic and I am happy to announce that we have initated a
60 patient, double-blind, vehicle-controlled study to properly evaluate the
effectiveness observed in our case reports. (Our research is funded by an
unrestricted educational grant from Cheminova, - we have no additional
conflicts of interest concerning the product). -I am also giving a talk at
the 1997 American Academy of Dermatology Annual Meeting[San
Francisco, March 21-26], Clinical Research Symposium entitled "The
Successful, Safe and Highly Effective use of Topical Zinc Pyrithione in the
Treatment of Psoriasis: A Report of 10 Cases". (see page 81(second
column, time:3:24) of the 1997 program for details). I've got some
tremendous before and after slides and I encourage you to attend the
presentation and make comments/questions. If possible, I will also
submit new case reports to the " Dermatology Online Journal " for your
review. I sholud also mention that I have recently become aware of
anecdotal reports that the spray, applied twice per day, above the nail
matrix, effectively treats psoriatic nail pitting(as the nail grows out)!!!!!!
We have decided to incorporate this into our clinical study! I have also
used Skin-Cap to treat other pruritic/inflammatory conditions including:
lichen planus, lichen simplex chronicus, atopic derm, severe scalp seb
derm/sebopsoraisis, pityriasis rubra pilaris, and notalgia paresthetica
with equally effective results!!!! It is acting like a topical NSAID and very
strong anti-pruritic!! If additional testing confirms the effectiveness of
this product, it truly could represent one of the major advances in
dermatologic therapeutics since steroids. Currently, most patients have to
pay for it out of pocket (~$39 for 100 grams, -Dovonex retails for about
$150 per 100 grams) The nice thing about the product is that it comes
with a money back guarantee, unlike most Rx meds.

Charles E. Crutchfield III, M.D.
-----------------


I am very interested in this product as well, and have been
happilysurprised to see that it seems to work, when similar zinc
prythioneproducts, such as Head and Shoulders shampoo does not seem to
have thiseffect. You mentioned chromatographic studies. Is the company
willing to allow youaccess to records that might disclose anything else
about the ingredientsin this product? Why should this product have an
effect that other similarproducts do not?I remain skeptical and am a bit
concerned about your enthusiasm. It isimportant to maintain a
dispassionate approach to the testing of anyproduct, especially if the
funding is from the company that makes it. I must admit that your
inclusion of a telephone number in your note soundsa bit like an
advertisement.As regards the comparison to Dovonex, it is my experience
that a 100gm tubeof Dovonex goes a lot longer way than a can of
Skin-Cap. Perhaps spray andointment applications cannot directly be
compared. Additonally, incomparison to other products containing similar
substances, Skin-Cap seemsgreatly over-priced.Having said this, I look
forward to any well done study that might give memore information about
whether this product has true therapeutic value.

Jerry Eisner
----------------


My results parallel yours, and I am excited that you are working
onobjectifying these anecdotal responses. I agree Skin-Cap appears
tooutperform Temovate and Dovonex.

Mark Valentine
---------------


<< The listed ingredients are:([activated]zinc pyrithione, sodium lauryl
sulphate, isopropyl myristate, and propel 45 (propellant)).>What are the
concentrations and what is the difference between "activated"zinc
pyrithione and non-activated? Is activated zinc pyrithione availableto
pharmacists for compounding?

Walter H. Wood, M.D.
-------------------


I called the toll free number given here for "Skin-Cap" (888 6 SKIN CAP)
and got an answering machine message that said it was for "dermatitis". I
left a message, first as a dermatologist, that I'd like to get some. There
was no response in 2 days time. I called again as a layperson, again with
no response in 2 days. I then got the local number and address in Miami
from the information operator for Cheminova America. The first time I
called I got an answering machine message that did noyt identify who or
whom I was calling, but said that I should leave a message and they would
call back, which that have yet to do. The local, Miami, number for
Cheminova is 305 825 7008; the local address is 6073 NW 167th Street,
Miami FL 33015. I may try to visit if I get an extra half hour to waste.

Michael Fetterman
----------------


The toll free number that I have been giving to patients is
888-469-7546. They seem to be getting a good response at this number.
I have now suggested this for 4 patients, including a physician. All
have had dramatic responses. I'll be happy when I see a controlled
study. It sounds too good to be all placebo/ moisturizing effect... I hope
it doesn't turn out to be just the latest "fish oil."

Mark Crowe, MD
-----------------


Has anyone had any positive results with Skin Cap spray? I recall
someearlier discussions on the list a few weeks ago regarding this. I had
apsoriasis patient recently who has tried PUVA, MTX, Dovonex,
topicalsteroids, etc. who elected to go to Memphis to Dr. Rosenberg for
hisantimicrobial treatment (antibiotics + Nizoral + Nystatin). This
patientwas only minimally improved on the regimen, and flared when he
tried todecrease his methotrexate dose. When I spoke with Dr. Rosenberg
about this,he mentioned that he was seeing good results with Skin Cap
spray - in factenough that his psoriasis clinic had been cut in half due to
the success ofthis OTC product. I have started a few patients on it but
have not yet seenthem back. It has to be ordered through the mail from an
800#. Has anyoneelse had success or failure with this product?

Mike Crowe, M.D.
----------------


I have been selling Skin Cap Spray in my office for about two months.
Eithermy patients are conspiring to delude me or this is the most
effective topicalproduct for psoriasis that is available in the USA at this
time. Once theyfind out how effective it is, patients never again complain
that theirinsurance won't pay for it. I see patients regularly who had
disappointingresults with PUVA, Tegison, and any topical you can name,
who are clearingdramatically with Skin Cap alone. It is orders of
magnitude quicker thanphototherapy, and I really think it ranks second
only behind methotrexate andcyclosporine in effectiveness. I am usually a
skeptical therapist, andhave never in 20 years felt this degree of
enthusiasm for any new therapy,excepting when Accutane became
available for acne......Try it if you don'tbelieve me. I have no financial
interest in this product, except as adispensing physician. In fact, I
anticipate losing a fair amount of incomefrom patients who will no longer
need phototherapy. We sold a can one Fridayafternoon to a 25 year old, a
15 year veteran of psoriasis therapy. She waswaiting on our doorstep
Monday morning bouncing with excitement and eager toshow us how the
Skin Cap was already working better than everything she hadever tried
after just 60 hours. You can order the stuff wholesale fromInterstate
Drug Exchange and save your patients the hassle of getting it bymail, and
you can save them a few bucks in the process.

Mark Valentine
----------------


I've been reading the messages about this stuff for quite some time, both
with amusement and bemusement.I just had a patient come back from
Mexico, and his widespread psoriasis is spectacularly better now that he's
using Skin Cap. He's certainly better then the anthralin, Dovonex, and
topical steroids I've prescribed ever got him! He's convinced it's this
product, and not the anthralin and Mexican sun, that made him so much
better. We'll see.

Robert I. Rudolph, M.D., FACP
-------------------


I'd be interested to know the serum zinc levels of people treated with
SkinCap - if there is enough inhaled or taken up through the skin the serum
zinccould perhaps reach toxic levels.

Kevin C. Smith MD FRCPC
-------------------------


Hope I am not totally wrong, but the thing is called Capsoft here. It is
produced by a rather small company in Hamburg. About one year ago, they
had a big scene in a quite popular TV talk show. There, the Capsoft fans
(and the company for sure) complained that no medical center was ready
to perform clinical trials without getting paid for that. On the other hand,
on my request they just sent one specimen, so I couldn't make experiences
with this magic product. And who would recommend the patients to buy a
rather expensive spray instead of prescribing a conventional drug for
free?Hans J. KammlerJena, Germany, LazyEuropeI have their address and
phone no. at the office and will post it tomorrow if no one else posts it
sooner. The latest study I read was in The Townsend Letter, an
alternative healing journal, and I believe was written by a Vet. I can
getreprints or more info if anyone desires--I have not used this product to
date.

Walter Yourchek
--------------------


Phone # 888-469-7546; also available thru mail order house
IDE(Interstate Drug Exchange)

Jerry Bock
---------------


For those who have asked me about purchasing Skin Cap:I buy it from IDE
Interstate, Inc. Their phone 1-800-666-8100, or fax
themat1-800-433-3291.

Mark Valentine
---------------


I had my pharmacist mix up a number of different formulations ofzinc
pyrithione. The next step is to see which one works. If oneconsiders
azeleic acid: It only works if the mitochondria arefuntioning. On can prove
this in bacterial cultures by adding sodiumazide (which kills
mitochondria) If one adds sodium laurel sulfate tothe bacteria nothing
happens. If one adds azeleic acid nothing happens.If one adds them
together the bacteria should lyse (as they do incultures not treated with
sodium azide) Again nothing happens. Thisshows azeleic acid is actively
transported into the cells, sincestopping the respiratory machinery stops
its action. I realize theazeleic acid analogy is odd here but the take home
lesson is that thereis probably an interaction between the zinc pyrithione
and one of theother ingredients, rather than a pure zinc effect, just as
there is aninteraction between azeleic acid and the sodium laurel sulfate.
Azeleicacid does nothing by itself. Zinc pyrithione probably doesn't
either.I'll let you know when I figure it out.

Haines Ely
-------------


According to the Psoriasis Foundation, the original Skin Cap Spray
containeda steroid as well as ZNP. The steroid has now been removed, and
the FDA isinvestigating the product further. Please, you European
dermatologists, tellus more about the product.

Yelva Lynfield
--------------


The source I found was Progressive Labs in Irving
Texas-1(800)527-9512.I called them today, and their Spray is about $21
(for3.33 oz) to the Doc. The propellant is butane. They stated that they
now have a U.S. version in an environmentally safe pump bottle for about
$12.50 for 4 oz.,so I ordered some to try. The article I read (with
impressive before and after pictures) was in The Townsend Letter, Jan.
97, and written by Morton Walker, DPM, Stamford, Conn. Anecdotally, I
saw a severe psoriatic this am who has been using Skin Cap Spray to one
side of her body for two weeks and with very impressive results--I'ma
sceptic, but will give it a fair evaluation, and report back later.

Walter Yourchek
-------------------


I have a sample of "ecological" Skin Cap from Cheminova U.K. Ltd.
Customerservice 800 61 spray (77729)It has 2 mg zinc pyrethrone and 1
mg methyl ethyl sodium sulfate per ml. "forrelief of itching, irritation,
redness, flaking and scaling associated withskin conditions." No mention
of psoriasis. No advice about how often itshould be applied.

Kevin C. Smith MD FRCPC
------------------


I have yet to have any patients tell me about it.However, another
dermatologist in the group had several patients with good response to it,
and about twice that number who failed to respond to it(so he tells me).A
lot us us will be at World Congress in Sydney, where presumably we'll
hear about anything remarkably good and new.

Michael Fetterman
------------------


While this is clearly belaboring the point, I still want to keep talkingabout
Skin Cap. I too have now had several patients return/call withglowing
reports, including two who were on systemic therapies and are nowoff
them, and reportedly clear (in one case, truly clear, confirmed on
myexam). I of course see my professional career treating and
researchingpsoriasis vaporizing as Skin Cap revolutionizes dermatology. A
couplequestions are raised:1. If this stuff is really so good, and has been
available in Europefor a decade, why don't European derms talk about this
stuff??? Do they know something we don't about toxicity or efficacy, or is
this a conspiracy to deprive patients of a drug which would cut their
practices by 50%? (see Dr. Crutchfield's original post in which he states
it'seffective for LP, LSC, atopic derm, seb derm, etc etc). I wish we could
get more feedback from Europe: anyone visiting over their soon?2. If it
truly is this good, I believe this represents a pharmacologicalparadigm
shift which would be equivalent to proving that homeopathic remedies are
indeed effective. Mind-boggling to claim that zinc pyrethione can do all of
this.3. It also would essentially negate the unbelievable volume of
research into diseases such as psoriasis, as it is hard to believe a simple
productlike this works through traditional immunological or
microbiological mechanisms.Keep me in touch with any comments or
experiences you all have with this stuff, directly or via the list. Thanks!

Mark Ling, M.D., Ph.D.
--------------------


Mark, Our friend and semi-guru, Al Kligman, says that everything works at
least once in dermatology. That may be what's going on here. It is hard to
believethat ZPT in teensy concentrations would not help dandruff (look
what happenedto the effectiveness of Head & Shoulders when P&G lowered
the conc of ZPT)but would clear psoriasis.

Guy Webster
----------------


Mass spec or NMR would be dandy, but liquid chromatography cheaper and
more readily available in any highschool chem lab.I'd suspect something
like that, but even so, TCA in my hands is no miracle drug.

Michael Fetterman
-------------------


Also have had a couple of psoriasis patients come in with
"glowing"reports of clearing with Skin-Cap-one in particular claimed to
have required mtx in the past, but now controlled with Skin Cap. My
response was to provide a sample of DHSshampoo with Zinc(label states
contains 2% ZNP) and to compare.Patienthas not returned so I'm assuming
complete satisfaction.

Pierre Jaffe, MD
-------------------


Just opened my Jan-Feb 1997 issue of JGD(J Geriatr
Dermatol1997;5(1):21-4) byCrutchfield et al titled "The effective use of
topical zinc pyrthione inthe treatment of psoriasis: a report of three
cases.Impressive photos depictingsignificant and rapid improvement.
Possible mechanisms discussed.Is itthe zinc? or is it the vehicle?is it the
combination of the above?A funread on a gloomy saturday afternoon.
Pierre Jaffe, MD
-----------------


Would someone with patients responding to Skin Cap please check a few
serum zinc levels and report back to us. I wonder how much uptake the
patients are getting through the skin and by inhalation. Hope there is no
heavy metal or arsenic in the spray (arsenic of course works great for
psoriasis but hasfallen from favor because of a poor long-term side effect
profile).Maybe look for adrenal suppression too - that might pick up an
obscurecorticosteroid derivative that could be missed if you didn't know
what tolook for on the mass spec / gas chromatography.

Kevin Smith
------------


When we discussed Skin-cap, I think I told you that the ZNP bar is great
forseb derm, and that I started to recommend it to psoriatics. About half
adozen of my chronic plaque psoriasis patient have returned for followup
afterusing the bar for a month, and neither the patients nor I was
impressed withits action except as a shampoo.

Yelva Lynfield, MD
-----------------


Read "The Effective Use of Topical Zinc Pyrithione in the Treatment
ofPsoriasis: a Report of Three Cases" published in The Journal of
GeriatricDermatology Jan/Feb 1997 by Chas. Crutchfield et al from the
Univ. of MinnesotaDept. of Derm. In this peer-reviewed journal they
describe dramatic successwith Skin Cap Spray used b.i.d. on one side vs.
triamcinolone oint. or placeboointment on the other. In one case, near
clearing occurred in 8 days. They havea bigger study underway.Like
everyone else, I was surprised but this product does seem
efficacious.They did acknowledge that other ingrediants like the
propellant may be afactor.

Philip Hughes, M.D.
-------------------


I saw a patient today who I have been treating for psoriasis for
severalmonths. He had failed to improve on Dovonex or Temovate or a
combination ofboth and had many inflammatory, eruptive, and pruritic
lesions all over thebody. I started him on Tegison two months ago at a
low dose, 25 mgm daily,and raised the dose to 25 mgm BID one month ago.
Two weeks ago, whilevisiting his psoriatic aunt in Puerto Rico, he was
given a can of Skin Cap. He used it only on the left leg below the knee. The
change was dramatic. The right leg had improved no more than 25% on
Tegison whereas the left legwas completely clear! I don't know how this
stuff works, but it seems towork better than almost anything in our
current armamentarium.

Isaac Novick, MD
------------------


No personal or clinical experience with Skin-Cap, but one of the other guys
in the group says he had several patients show phenomenal clearing of
scalp psoriasis and seb derm with it..but then found that like lots of other
products, was helpful for maybe an estimated third of patients.

Michael Fetterman
------------------


May I hear from anyone who has seen a failure to respond to Skin Cap?
Also, how about side effects? And success in non-classic plaque
psoriasis? The manufacturer claims a success rate of 85%, and I think
this may beaccurate, as I've seen four patients with negligible benefit out
of the fortyor fifty patients who have tried it in my practice, and it is
safe to assumethere are a few more failures out there who have yet to
report back to me.No one has discovered any side effects yet. I intend to
check zinc levels on any patients who are steady users of large
quantitities of the stuff, buthaven't yet had the opportunity. Anemia from
copper deficiency is the only theoretical side effect I am aware of.I
haven't tried it on pustular or erythrodermic cases yet. I have
anerythrodermic PRP patient and a refractory lichen simplex chronicus
patientwho are trying it, but no reports yet on results. I also don't know
how itperforms on palmoplantar areas yet. Scalps respond well to it.
We've sent afew patients home with the pump-spray formulation from
Progressive Labs tocompare with Skin-Cap, but again too early for any
feedback.

Mark Valentine
--------------


I am delighted to see some feedback regarding the Skin
Cap-typeformulation from Europe, where these zinc pyrethione products
haveapparently been available for years. I am still struggling with
theconcept of a product which is 85% effective, according to a recent
post,yet which has not apparently swept Europe by storm. I've given about
40or 50 of my most recent psoriasis patients over the last month info
reSkin Cap so I presume in a month or two I'll have more
substantiveexperience to report. More European comments??

Mark Ling, M.D., Ph.D
.------------------


In Germany there is a product called "Capsoft Regulativ-Spray".I don¥t
know if it is identic to Skin cap, but it containsZink-Pyrithion like this.
Unfortunately I have no personally experiencewith this product, but i read
about it in "Pso Magazin", the journal ofa german psoriatic group. Several
psoriatics write about their badexperiances with Capsoft. They describe it
as skin irritating.Dermatologists of the University of Hamburg saw four
cases withpsoriasis pustulosa after use of capsoft.

Andreas Eisenmann
---------------


It certainly isn't the zinc pyrithione in Skin Cap which makes it work.
Ihave mixed up gels, liquids, and creams with varying strengths of
ZPwithout much effect compared to the brand name stuff. I deleted
themessage about the propellant of Skin Cap spray so I couldn't ask
theauthor to e-mail me directly but I am extremely curious. What is
it?Haines ElyI just got back from visiting Vanderbilt Psoriasis Center.
Nurses statethat results with Skin Cap Spray have been mixed but
generally positive.They state that many patients have been more
impressed with a productcalled Apis. I am getting more
information.Anybody heard of it?

Trey Truett, MD
-------------------


Isopropyl myristate is a synthetic oil found in many cosmetics, and in fact
in some acne topicals, I think! I knew a dermatologist who thought it to be
comedogenic.My money is on the sodium methyl ethyl sulfate, or some
moiety derived from it, as being the (still) secret ingredient. Can anyone
here comment on (potential) carcinogenicity of alkyl sulfates ?

Michael Fetterman
----------------


This might help those of you who are running literature searches:In my
handy Sigma chemical catalog (every derm office should have one - mineis
kind of old - 1988) isopropyl myristate is listed as: myristic acid
ethylester (a synonym is: ethyl myristate).Myristic acid has a synonym:
tetradecanoic acid.In 1988 isopropyl myristate sold for 24.70 / 100 g for
the 99%, and 24.00 /liter for the 95%. Certainly much cheaper in bulk.

Kevin C. Smith MD FRCPC
---------------


Isopropyl myristate is "Liquid Wrench" I think it is also a maincomponent
of WD40. It is the agent which induces perioral dermatitis inmost
makeups sold as "oil free". What a coup! Thank you sooo much forthis
information. Liquid wrench is a lot cheaper! Haines ElyIndeed, I believe
there was a tabloid story a year or two ago about WD40 for psoriasis. I
believe everything I read.

Haines Ely
------------


Don't you believe the zinc has anything to do with it? Will you have
yourpatients put on Head & Shoulders and spray with WD40? (is it really
trueabout WD40 or is this just another "urban" myth?).

Eliot Mostow
-------------


As I mentioned in a previous note I've had my pharmacist mix up
zincpyrithione in every vehicle I can think of with only minimal results.
Imight add, only the solution with added B6 had any effect.

Haines Ely
-------------


Hans, as far as I can see, FK-506 have very different properties. FK-506
works as a topical agent on psoriasis. Cyclosporin doesn'teven work when
injected intralesionally in Psoriasis.

Rhett Drugge, M.D.
-------------------


After noting the possible association between Skin-Cap and WD40, one of
our Rheumatologists told me that many of his arthritis patients spray
WD40 on an inflammed joint and get temporary relief of pain. He believes
it works but also thinks that it may have caused one case of neuropathy.
Today, I recieved my first mass mailing for ordering Skin-Cap. The need
for credible data on safety and efficacy is clear!

John Melski MD
-------------


I hope it is forthcoming. However, I was able to speak with someone at
theFDA dermatology division Thursday, and she wasn't able to tell me
much. Iasked if I might be kept abreast of any investigation into the
safety of SkinCap. Apparently it is strictly against FDA regulations
torelease any information whatsoever about investigations or new
drugapplications that are pending. She was categorically unable to even
discloseif Skin Cap currently has any applications filed with the FDA. My
concernsabout patient safety seemed to not count for much in the FDA
scheme ofthings. She suggested I contact the office on Advertising and
Communicationsand lodge a complaint because of the illegal advertising
for psoriasiswithout an FDA indication. This I am not prepared to do.
Knowing how theFDA works, they would probably determine that it was
entirely safe, and thenproceed to confiscate all the product, since they
value form over function bya 10 to 1 margin.Meanwhile, my first feedback
(one patient only) on the zinc pyrithione sprayfrom Progressive Labs in
Texas is that it is not effective, at least whencompared with Skin Cap.
This is as Haines predicted. I also saw threepsoriasis patients yesterday
who, much to my dismay, failed to see muchbenefit from Skin Cap.

Mark Valentine
-----------------


I recently had a patient in with psoriasis resistant to topical therapies
but as it was not too severe she did not want to try anything else...yes, she
was in last week clear, using skin cap...as her lesions did not respond to
temovate it makes me wonder, despite a biopsy consistent with psoriasis,
if we are not dealing with more than one cause of psoriasis, even though
the clinical/histological pictures are the same...so that type 2 for
example, may be steroid/mtx/etc resistant but skin cap responsive... any
comments?...

Steve Emmet
--------


Well, I've finally bowed to my own curiosity and started to use Skin Cap
Spray. Just a few patients, paired comparisons with one side being
treated in the usual fasion for that patient, and the other with Skin
Cap...very informal, careful observations and phone calls.Preliminary
thoughts...impressive results. Some of the " light patients " with
resistant areas have cleared. The untreated areas, no change. Patients on
Mtx with some residual plaques...cleared on the treated sides, no change on
the other. No experience yet with nail problems, looking for more date on
scalp psoriasis.Continuing to study, more information in a few weeks.

Elliot Puritz
-------------


Skin Cap seems to be working ok here in south hemisphere,too. One 75 yr
oldpatient with widespread psoriasis had some control,before,but taking
manydrugs,etc. Like magic, his only 15 days applying S cap has lead him to
morethan 50% clearing - we are all amazed! He complains of the price, but
he'svery happy.Hope you don't find any bad thing about this product.

George Leal
------------


Dear all,one of my psoriatic patients brought me today the insert of SKIN
CAP, newlymarketed in Brazil (supposedly the same). It says- "S Cap is a
modernproduct, made of A TENSOACTIVE (METHYL ETHYL SODIUM
SULPHATE) THAT HASANTISEPTIC AND KERATOLYTIC PROPERTIES
(ELIMINATES EXCESS OF EPIDERMIS IN ALARGER THAN NORMAL SCALE). THIS
TENSOACTIVE RECEIVES A POTENCIALIZATIONFROM ZINC PIRITHIONE, that
reforces ist antibacterial and antifungal actions(alas , decisive for the
control of the affection).I am doing a little research on methyl ethyl
sodium sulphate, but so farunproductive.

George Leal
-------------


I have received the following communication from Richard Faiola,
M.D.,Medical Director of "Noble Products, Inc." a Distributor of Skin Cap in
theU.S. According to the letterhead he is a family practice doctor
andmanaging partner of L.G. Steck Memorial Clinic in Chehalis, WA.

Subj: Re: Skin CapDate: 97-03-10 02:52:57
From: FaiolaR@localaccess.com (Richard Faiola)
To: WHWoodII@aol.com
Per the manufact. they have appropriate registration with FDA and
anational drug identification # (its on the package). FDA "approval" of
aspecific product like SkinCap is not required and has neither been
soughtnor granted. Its ingredients are from among those for which the
FDA haseither granted a "generally recognized as safe" designation or has
apermissive "monograph" on. In other words, manufactures are free to
usethe ingredients of Skin Cap without specific additional FDA review. It
isan OTC product. It does not require New Drug Application,
norsafety/efficacy data when labeled for the cosmetic indications
of"Dandruff" and "Seborrhea." They can not label it for the
medicalindication of "psoriasis" The FDA removed "the heartbreak of
psoriasis"from the cosmetic to the medical several years ago. That does
not mean Ican not share with me colleagues its utility for symptoms
associated withthat disease, but our consumer advertising will be careful
to make clearthat it is for the symptoms of "itching, flaking,
inflammation" associatedwith various skin disorders. A double blind
placebo controlled study isbeing completed in now, by an American
researcher, independent of thecompany. I believe, but have not first hand
confirmation that the resultsare confirmatory. The researcher had a bit
on the Internet 2 or 3 weeksago, responding to a question, and reported the
results as promising andalso that he expected to be presenting to the
Derm meeting in SanDiego. The company sponsored some studies in Latin
America--I have reviewed them. They showed good results, but they do not
meet my own or usual scientificstandards. The active ingredients are
those listed in my letter. ZincPyrithione, sodium laurel sulfate (an
irritative detergent in toothpasteand several other hygiene products.
There is some alcohol and otherpresumed inactive excipients and
propellants. The zinc portion is, ofcourse, the same as in "Head and
Shoulders." I personally believe the SLSfacilitates the absorption of the
zinc, while acting as a directkeritolytic (SLS has been shown to permit
the dangerous absorption ofnickel transdermally in foundry workers, no
known studies directly on zinc,but then unlike nickel zinc is a desirable
nutrient). Bottom line: Thestuff is relatively cheap compared to some of
our other options, looks likeit should be reasonably safe, and IT WORKS.
About 50,000 persons are orhave used it in the US
----------


i have a very cooperative japanese patient with basically total body
psoriasis, untreated, (mentioned as i don't know if japanese skin may
respond differently from caucasian)...who used skin cap bid on one arm and
temovate cream bid on the rest of his body...at three weeks of temovate
and two weeks of skin cap, the skin cap was clearly better, with flatter
plaques, less redness, less itching....

Steven D. Emmet, M.D.
---------------


Another glowing report. 55 year old with 25-30% surface area
psoriasissince l959, recalcitrant to many rx's in the past including PUVA.
CLEARafter one month, and 6 cans, of Skin Cap aerosol. No kidding.IWe will
see if it will be the second non-prescription drug put on theformulary. The
first being Unibase.

Diane D Thaler
---------------


A few weeks ago I suggested to a half-dozen psoriasis patients that they
tryLiquid Wrench on their psoriasis ( eg. Wal-Mart, $4.99, mostly
isopropylmyristate) and the first one came back yesterday -- happy lady:
not amiracle, but considerably improved.

Kevin C. Smith MD FRCPC
--------------------


Another glowing report for Skin cap spray here also........56 yo
recalcitrantpsoriatic who we have been keeping maintained with modified
Goeckermantherapy, topical steroids and dovonex. One week and two
bottles of skin capspray and she is TOTALLY CLEAR...........I am impressed!I
have just place 5 more patients on it and will report later.

Jeff Marmelzat
-----------------


... personal experience. I've given SC to between 50 and 100 patientsover
the last two months. My experience is that it is an unbelievablyeffective
drug for a SUBSET of patients, perhaps 50% in my estimation.They get
dramatic clearing, often within a few days of starting, andwithin a month
generally are to the point where it's tough to see wherethe psoriasis used
to be. Phenomenal. Others simply don't respond, or evendevelop a
significant irritant dermatitis. I worry about the stuff a lot,since I don't
believe it's just another Head and Shoulders, but it is soeffective that at
least until someone demonstrates potential toxicity itis hard for me to
justify not using it. Still, I'm keeping my ears open.The demand is so great
now that the Nova folks are 4 weeks back ordered.Finally, I had some
patients try a "knock-off" in a pump spray bottle. Wassupposed to be just
as good as SC. It was 100% ineffective, a totalfailure. BTW, the local
distributor, a former patient, apparently admittedto one of my current
patients who had tried the knock off, that he hadbeen forced to start using
"real" SC again to control his psoriasis

Mark Ling, M.D., Ph.D.
--------------------


I understand that there is good efficacy and tolerability in early
trialswith calcipotriol (know as calcipotriene in the US) in an isopropyl
myristatebase for scalp psoriasis.Isopropyl myristate is of course the
same stuff found in Skin Cap. It is saidto greatly enhance permeability of
the scalp to calcipotriol.

Kevin C. Smith MD FRCPC
----------------------


the steroid rumor has surfaced with Skin-Cap repeatedly: I think
thearchives may contain prior discussion. Dr. Crutchfield at U. Minn. has
hadit analzyed with GC and clearly states there is no steroid peak
identifiable. That of course does not mean that Skin-Cap might not cause
striae.

Mark Ling, M.D., Ph.D.
--------------------


For those who may have missed out on the earlier discussion, Skin Cap is
anOTC spray product that contains zinc pyrathione (the stuff in Head
&Shoulders shampoo) in an organic base that is largely isopropyl
myristate.Apparently this base is important for allowing penetration of
the zinc tothe deeper layers of the epidermis. This product is
manufactured byCheminova International Laboratories and distributed in
via the Internet byNet Nova Pharmaceuticals
(http://www.clearskin.com/).The spray works dramatically in somewhat
more than half of patients withplaque-type psoriasis when sprayed on bid.
An interesting facet of it isthat the severity of the problem doesn't seem
too much of a factor inwhether someone will be good responder or not,
meaning it may work on someof your severe longstanding problem
psoriasis patients that don't respondwell to much else.I know it sounds
like a con game, but it is true. When it works it's betterthan Temovate
(works faster too) and (so far) doesn't seem to have thetachyphylaxis
problems of topical steroids.

It is cheaper to buy in largequantities, so if you are going to start
recommending it, you might do yourpatients a favor by being their volume
purchaser and reselling it to themat near cost.The toxicity of this
preparation has not yet been studied very well,although Zinc is one of the
least toxic metals (compared with Cadmium,Mercury, Arsenic, etc.), and
has even been used orally to treat a number ofdiseases in the past
including Wilson's disease [1-3], cirrhosis [4], andsickle cell anemia [5] to
name a few. Dermatological diseases that havebeen treated with it include
acne (doesn't really work very well) [6-10],chronic mucocutaneous
candidiasis [11] and interestingly enough, psoriasis[12]. Before you all run
out and put your psoriasis patients on oral zincsulfate, please note that
this double-blind trial with 25 patients wasunsuccessful. 600 mg/day of
oral zinc sulfate is fairly well tolerated withmainly GI side effects, so I
am assuming for the moment at least that thisSkin Cap stuff is not going
to be too toxic. As well as it works, it's notgoing to go away unless it
turns out to be a lot more toxic than Ianticipate, however. Somehow this
got by the FDA, I suppose because zinc pyrathione had been around and
shown to be safe (Head & Shoulders shampoo).However the Cheminova base
is a whole 'nother ballgame and turns zincpyrathione into a sure 'nuff
potent topical drug. Stay tuned.

References:
1. Hartard C, Kunze K: Pregnancy in a patient with Wilson's
diseasetreated with D-penicillamine and zinc sulfate. A case report and
review ofthe literature. European Neurology 34(6):337-40, 1994.
2. Heckmann JM, Eastman RW, De Villiers JC, et al.: Wilson's
disease:neurological and magnetic resonance imaging improvement on zinc
treatment[letter]. Journal of Neurology, Neurosurgery & Psychiatry
57(10):1273-4,1994.
3. Shimon I, Moses B, Sela BA, et al.: Hemolytic episode in a
patientwith Wilson's disease treated with zinc. Israel Journal of Medical
Sciences29(10):646-7, 1993.
4. Marchesini G, Fabbri A, Bianchi G, et al.: Zinc supplementationand
amino acid-nitrogen metabolism in patients with advanced
cirrhosis.Hepatology 23(5):1084-92, 1996.
5. Gupta VL, Chaubey BS: Efficacy of zinc therapy in prevention
ofcrisis in sickle cell anemia: a double blind, randomized
controlledclinical trial. Journal of the Association of Physicians of
India43(7):467-9, 1995.
6. Cunliffe WJ, Burke B, Dodman B, et al.: A double-blind trial of azinc
sulphate/citrate complex and tetracycline in the treatment of
acnevulgaris. British Journal of Dermatology 101(3):321-5, 1979.
7. Michaelsson G: Oral zinc in acne. Acta
Dermato-Venereologica.Supplementum Suppl(89):87-93, 1980.
8. Orris L, Shalita AR, Sibulkin D, et al.: Oral zinc therapy ofacne.
Absorption and clinical effect. Archives of Dermatology114(7):1018-20,
1978.
9. Weimar VM, Puhl SC, Smith WH, et al.: Zinc sulfate in acnevulgaris.
Archives of Dermatology 114(12):1776-8, 1978.
10. Weismann K, Wadskov S, Sondergaard J: Oral zinc sulphate
therapyfor acne vulgaris. Acta Dermato-Venereologica 57(4):357-60,
1977.
11. Polizzi B, Origgi L, Zuccaro G, et al.: Case report:
successfultreatment with cimetidine and zinc sulphate in chronic
mucocutaneouscandidiasis. American Journal of the Medical Sciences
311(4):189-90, 1996.
12. Burrows NP, Turnbull AJ, Punchard NA, et al.: A trial of oral
zincsupplementation in psoriasis. Cutis 54(2):117-8, 1994.

Mark Naylor, M.D.
------------------


this is an updated report. The patient is the "elevated sgpt
psoriasispatient",presented in these lists weeks ago, to whom I started
SKIN CAPSPRAY. I AM COMPLETELY AMAZED!!!!!! ASTONISHED! - with just one
week of thespray use, he GOT RID OFF ALL HIS LESIONS, SCALP AND BODY!!!!
I saw himtoday,he is completely "clean", and we are all very happy! And he
hasn'tapplied it for 2 weeks.We are also happy he doesn/t have to take Mtx
(or anything else),so far.I hope this thing doesn't cause tachyphylaxis,or
anything else, for it wasfantastic. I have some other patients using it,yet
to come back.Thanks

George Leal

Dear Drs. Crutchfield,
I have had an excellent success with the few patients to whom I haverx
Skin Cap Spray. Now I ask you, once achieved this result, how do
youprescribe maintenance therapy? I have told them to apply the spray
once aweek, in the places that had the lesions before. Have you seen
tachyphilaxis?
George Leal
--------------

Skin cap spray has produced an acneiform eruption in several of my
patients whenused on the face or neck. Not surprising after all the talk
about commoningredient in WD 40, Liquid Wrench and Skin Cap Spray.

Philip Hughes, M.D.
--------------


Diane - there is a primary irritant contact dermatitis that occurs from
timeto time with skin cap - I've seen it in one caregiver who developed
itwithin 48 hrs on forearms where some of the mist settled - cured by
usinglong sleeves and greater care.Other notes on Skin Cap.Local WalMart
now has it behind the counter - too much stock "shrinkage"from folks
taking a five-finger discount. How many little cans could you fitin *your*
pocket or purse? The sign of a successful product, I guess.Helpful
money-saving hint. Spray a bit on a china saucer, use a finger toapply dabs
quickly to areas you don't want to spray ( e.g. spots on face orguttate
lesions or even the returning spots when the disease wants to comeback).
If worried about contact, wrap applying finger in SaranWrap then dipand
dab.I have now treated three DLEs (BID x 2-4 days then 1/day x a few days
thewait and watch) and two non-specific intertrigos in males (single
spraytwicw a week only - done in the office for good control and so I can
watchcarefully the results.

Bill Danby
--------------


I now have one patient with extensive psoriasis who is using Skin Cap
insome areas & Liquid Wrench in others. She feels there is some efficacy
ofLiquid Wrench & she reports that both products have an identical feel
onthe skin. However, the Skin Cap appears to be the more effective
product.

Jerry Bock
-----------


I have had a number of patients develop acneiform eruptions (acne
venenata) from Skin Cap Spray, which isn't surprising.

Philip Hughes, M.D.
-----------------


Just an update on my experience with SkinCap. I stock it so as to provide
my patients with their first can ( charge $30). I have arranged for a local
pharmacy to carry it and ask pts to get more there. I explain that I do not
know why it works, and despite lack of knowledge about all the
ingredients, have not heard any significant comments from those on this
list about serious side effects.The patients are uniformly reporting
favorable effects on scalp, body and hands. I have not seen any significant
side effects, except for a little dryness in some cases.

Jerry Eisner
--------------


I've been following the Skin Cap discussions with interest, and
havepurchased some and am now having some patients use it. These are
allpatients I've seen for years, and who have resistant psoriasis.
Theseare the kind of patients we all have a lot of: good patients who
havetried many therapies (of all sorts, including the "big guns"), and
whoremain active, and difficult to treat.I just got a marvelous letter from
a young man with very widespreadpsoriasis who tells me his psoriasis is
better now (after one week) oftherapy, then ever before.I asked him to
come into the office, and guess what: he's spectacularly better. I have
never seen any response in any psoriasis patient like this in 22 years of
practice! Ican't wait to hear from other patients. I'll let the group know
about the follow-up. As for now I stand amazedand delighted!Had another
lady come into the office to show me the effects of Skin Capon her
widespread and very chronic scalp psoriasis (which has notresponded well
to topical steroids, tars, acid preps, etc. over theyears).After 5 days of
use she is clinically almost totally clear of PSO. She and I are pleased
andastonished.

Robert I. Rudolph, M.D.
-------------------


Has anyone seen (not heard of) any significant untoward reaction that
they believe is more likely than not due to Skin Cap? I have not seen any.
Jerry Eisner >>So far naught but an occasional complaint of stinging in
over 225 canssold.....One of my most impressive responses: A man with
severe pustular psoriasis ofthe hands, with marked swelling, secondary
anonychia, and inability to evenbutton a shirt or zip a zipper, had been
completely disabled by his diseasefor at least 8 years, and essentially
unresponsive to MTX, PUVA, topicalsteroids, and Dovonex. Symptoms
reduced to mild peeling with two cans ofSkin Cap......

Mark Valentine
--------------


In response to the question of adverse reactions to Skin Cap: We (I and
Drs. Lewis and Zelickson) are currently conducting a 60 patient double
blind, vehicle controlled study on the treatment of topical zinc pyrithione
spray (skin cap) for psoriasis. We published the results of pilot studies in
the Jan/Feb issue of the J. of Geriatric Dermatology (they accidentally
reversed the before and after photos-so please "reverse them back" if you
read the article), and recently spoke at the clinical research symposium of
the American Academy of Dermatology (San Francisco, 1997) and
presented at the Society of Investigative Dermatology (Washington DC,
1997) and have a published report that can be viewed on the Dermatology
Online Journal;web address:
http://matrix.ucdavis.edu/DOJvol3num1/zinc/zinc.html Essentially, in our
clinical experience of well over 100 patients, in about 5-10% of patients
we have seen a very mild and transient flare of the psoriasis that falls off
in the first 1-3 days. I warn my patients about this and tell them to treat
through it, unless it becomes severe (which it has not, as of yet). About
20% of patients complain of dryness and/or irritation. For the dryness, I
recommend a moisturizer of choice about 1 hour after applying the
Skin-Cap. For moderate to severe irritation, I recommend just QD
applications. I have had 1 or 2 clinical patients stop using due to
irritation. None of the study participants have left the study for adverse
reaction reasons. There is a post healing erythema that is replaced by
post-inflammatory pigmentation that fades with time. Although I have
not personally seen it, I have heard of reports of tachyphylaxis-like
reactions from colleagues. Additionally, there have been reports by users
on the psoriasis support groups of what they term as a "rebellious
psoriasis", i.e. red papules and possibly pustules arising at the periphery
of healing plaques. The only explanation that I have for this, (since I have
not personally seen it), is a koebnerization reaction secondary to
irritation of normal skin included in the "treatment spray area". I have had
a few patients who have significant improvement to a point, but don't
totally clear. The next time this happens I'll be tempted to try
combination therapy (add a potent steroid or Dovonex, or both). I have not
tried combination therapy to date, but this may be a good group to try it
on. Has anyone else tried combination therapy? I have seen a small group
of patients who, with compliant BID applications, don't start to respond
until week 5 or 6. For this reason, I don't consider anyone a treatment
failure unless they have compliantly adhered to a BID application for 8
weeks.We'll have more to say as we conclude the study (August 1997)and
analyze the results. We are also looking at the treatment of psoriatic
nails by BID applications above the nail matrix, and also looking at
periodic, treatments (once or twice per week) to cleared "trouble areas"
to reduce or prevent future flares. We are also initiating cellular studies
with Mark Pittelkow at the Mayo Clinic to get a better understanding of
the cellular mechanisms of action.What are others experience with the
tachyphylaxis/rebellious reactions??? I donít know if there is a "safe"
limit to the surface area that can be treated. Cost seems to be the
limiting factor at this point.Has anyone had any luck treating palm/plantar
pustular psoriasis?? I've had a good response in 1 patient of 2, with a 3rd
patient being evaluated currently.What about keratoderma
blennorrhagicum? (I haven't tried it on this condition, yet). I have also
used it very successfully on lichen planus: 4 of 4 patients with near to
total clearing, with a 5th patient being evaluated currently.I understand
that there will be several other "knock-off" zinc pyrithione sprays
available soon. I'm happy to hear of this, especially if they work.
Competition is good, and hopefully will drive the price down, a complaint I
constantly hear from my patients who have to pay the OTC price of $30-40
a can, and who can easily go through several cans to gain control.I enjoy
reading about the experiences of others, good and bad, of this interesting
treatment. Iíll share additional information concerning our research,
with the group, when appropriate.

Charles Crutchfield III, MD
------------------------


The isopropyl myristate of Skin-Cap is a proven comedogen. However that
does not make it "the mechanism". It is fairly well proven, I think, that the
major route of penetration of topical agents is via the follicles however.If
we can assert that zinc pyrithione under occlusion is capable of this
dramatic result in psorisis and other inflammatory dermatoses, then it
would be a cheap study to see if topical zinc pyrithione and other
comedogens or occlusive dressings do the job.I doubt it.Certainly the
isopropyl myristate content along is basis to avoid acne prome regions.

Michael Fetterman
--------------


I have been using Skin Cap for several months and so far the results
areremarkable. In my opinion Skin Cap blocks a step very high up in the
cascadeof events that gives rise to a psoriatic plaque and thereby stops
the wholeprocess cold. All the other medications we use act to suppress
psoriasis atthe end of the cascade. When we find out how it works we
will probablyuncover something very basic in the pathogenesis of
psoriasis.I order Skin Cap in bulk from Acu-Derm and sell it to patients at
cost. Itell them that if the medication works they can order it
themselves. Thetoll-free number is on the box. Do I feel bad about giving
patients a medication of whose mode of action I amignorant? No, because
the vast majority obtain quick and complete relieffrom a bad disease that
I have not been able to give them using variousexpensive medications all
of which have their own set of side effects. Idon't think I could, in good
conscience, start a psoriatic patient onTegison, Methotrexate, PUVA,
Cyclosporin, Hydroxyurea, or even UVB withouttrying Skin Cap first.

Isaac Novick, MD
------------------


I just wanted to alert the members of some information I became aware
of last night. According to an article published in De Telegraaf, May 29,
1997, the Minisrty of Health of the Netherlands pulled Skin-Cap off the
market because it was discovered to contain a potent steroid. Early in
1996, Skin-Cap was banned from the Austrian market because if was
found to contain high levels of triamcinalone (~0.5%). I received the
Austrian information from a posting to a psoriasis support group by the
Canadian Distributor of Skin-Cap (her name is Patricia Cross, email
address:pcross@rideau.carleton.ca). According to an official cheminova
company statement, a few lots were accidentally "contaminated" with
triamcinalone. They were unsure how this happened and plan to try to
reintroduce it back into the Austrian market sometime in the future.
Concerning the Netherlands- Recently, a high ranking official at the
National Psoriasis foundation did telephone and speak with an official at
the Ministry of Health in the Netherlands who was involved with the case
and was told that the steroid found was clobetasol proprionate!We are
currently finishing a 60 patient, double blind, vehicle controlled study on
the use of topical zinc pyrithione (s. cap) to treat psoriasis. Naturally, we
were concerned and very interested in this development. Because of early
rumors of steroids(which recently went fom rumor to fact by the
cheminova/Canadian statement) , we did test the study samples for
triamcinalone (HPLC and nmr) and found NO triamcinalone. It is my
understanding that it is very difficult to detect any random steroid- it
must be looked for specifically, a time consumimg and costly fishing
expedition if one is to be thorough, which certainly was beyond the scope
of our study. The company stands by its statement that U.S. Skin-Cap
contains only: zinc pyrithione, isopropyl mysristae, propel 45 (iso-butane)
and sodium-lauryl-sulphate (although initally they claimed that the
sodium-lauryl-sulphate was "sodium-methyl-ethyl-sulphate", a situation
which is still confusing. I have sent a letter (fax) to Cheminova today
(June 13, 1997) asking for an explanation of the Netherlands events and
to, once again, confirm that the U.S. product does not contain steroids of
any kind. Has anyone seen immediate blanching, steroid atrophy, or
tachyphylaxis-like reactions in s. cap patients? I have not, (but I have
heard of a few tachy reactions).Does anyone else have any insight into this
interesting situation? I will keep the group updated on the response and
any additional information that I come across. We will now try to check
for clobetasol proprionate, as I am sure others (FDA, etc) will also.

Charles Crutchfield
-----------


I'm sure all dermatologists have prescribed triamcinolone and clobetasol
for a dozen years or more in the hopes of containing and trying to "cure"
psoriasis. Has it ever worked? Has it ever worked like Skin-Cap? Never!I
have, as we speak, discharged 14 psoriasis patients, some of whom have
had their ailment for more than 30 years. I either have discharged them, or
they call me and tell me they are cured. And they thank me and some say
they pray for me. And these same patients have used, on and off, all the
potent steroid creams, ointments, lotions, and sprays, including
clobetasol (Temovate -- cream, E-cream, ointment, gel and scalp
application). With little, if any, significant results.So if there are a few
"drops" of clobetasol in one (or more) of these sprays, how do you account
for the almost immediate relief -- subjective and objective -- of
psoriatic patches? And thick scalp psoriasis? And you all have used
clobetasol, haven't you? Have you gotten similar results?There has to be
another answer. Meanwhile, I'm happy that many of my patients are happy
with their results.

Jerry Litt.
------------------


I can only say that I have never had the results with clobetasol,
Dovonex,methotrexate, whatever, that I am seeing with Skin Cap.I have
used it successfully on dyshidrotic eczema of the hands that wouldnot
respond to clobetasol.I most recently am using it on an elderly woman
with intertrigenouserosive and pustular psoriasis. I believe the acute
episode was triggeredby her diabetes,indwelling urinary catheter with
infection, and possibly yeast. She wasinsevere pain from the erosions and
we placed her in the hospital. I amapplying Skin Cap once daily in this
area. I am also using Tegison 25mg,IVCipro, oral Diflucan, and topical
Desonide (once daily). Within 24 hoursher pain was resolved. Within 48
hours her pustules are resolving and theerythema fading. Whatever is in
this stuff, the benefits outweigh therisksso far. The patient thinks I
perform miracles. Keep us posted.

Jerry Eisner
------------------


I agree with Drs. Litt and Rudolph, I've never seen anything work like
skin-cap. Including our study, Iv'e used it in well over 100 patients with
only a handful of failures. I've used it against psoriasis (monotherapy
and combination therapy with the residual plaques of MTX and PUVA),
lichen planus (ESPECIALLY LP-see previous posting), atopic dermatitis,
LSC, prurigo nodularis, etc. I have had patients cry in my office at their
results!!! The same story we all have had-20 and 30+ years without relief,
now clear!!!Yes, I've used triamcinalone and clobetasol p., but I've never
used TMC at 0.5% in a novel/unknown liquid vehicle. Same with clobetasol
p.-and as we well know, the vehicle can have a tremendous effect on the
potency of a steroid, not to mention if the steroid is at higher
concentrations than currently used. I don't know how much clobetasol p.
was found in the Netherlands version, but I never intended to imply that it
was just "a few drops".The facts are plain, and I certainly agree with Drs,
Litt and Rudolph, I've never seen any current steroid in use work like s.cap.
Assuming that the U.S. version does not contain steroids (and we have not
found any steroids in it), we are intiating cellular research with M.
Pittelkow at the Mayo Clinic to better elucidate the mollecular mechanism
of action.In addition to conducting the only double blind, vehicle
controlled, skin-cap study, I've wrtitten papers on skin-cap, spoken at the
AAD, and presented at the SID and other medical conferences. I, as well
as any other dermatologist, and all of my patients that have benefitted
from skin-cap, really wish for the best for skin-cap. I'm happy to have it
at my disposal, I use it often, and my patients are delighted. I just
thought I would be derelict in my duties if I did not alert the group to the
Netherlands and Austrian incidents. If skin-cap works so great, why
would they put clobetasol p. in it???? I'll keep the group posted on any
new findings.Thanks for your comments. I share your enthusiasm and
curiosity.

Charles Crutchfield
------------------


I have noticed that several pharmacies in my area are now carrying
it,probably as a result of Mark V's and my proselytizing to our
patients.However, prices vary from $35 to $45 a can. Mark, a pharmacy in
Stanwoodis charging $45 according to one of my patients.

Jerry Eisner
------------------


After last comments concerning skin cap I decided to make a trial in two
ofmy most unresponsive patients affected of localized scalp psoriasis. It
worked in 2-3 days to clear their patches. After using it for 14 days Itold
to use it 2 days per week for two more weeks and then stop.I'm really
impressed. I wonder how much time will they be free of lesions.Any of you
have experience in relapsing times. And what to do in the caseof
tachifilaxis?
Toni Azon. Cambrils. Spain.
------------------


I can only say that I have never had the results with clobetasol,
Dovonex,methotrexate, whatever, that I am seeing with Skin Cap.I have
used it successfully on dyshidrotic eczema of the hands that wouldnot
respond to clobetasol.I most recently am using it on an elderly woman
with intertrigenouserosive and pustular psoriasis. I believe the acute
episode was triggeredby her diabetes,indwelling urinary catheter with
infection, and possibly yeast. She wasinsevere pain from the erosions and
we placed her in the hospital. I amapplying Skin Cap once daily in this
area. I am also using Tegison 25mg,IVCipro, oral Diflucan, and topical
Desonide (once daily). Within 24 hoursher pain was resolved. Within 48
hours her pustules are resolving and theerythema fading. Whatever is in
this stuff, the benefits outweigh therisksso far. The patient thinks I
perform miracles. Keep us posted.

Jerry Eisner
------------------


Does anyone doubt the credibility of this company?Could arsenic, mercury
or some other toxic heavy metal account for the observed effects?

Steve Feldman, MD
-----------------


In reference to Dr. Smith's post, below, I certainly agree with him, and, as
I have posted to the group on several prior occasions, Skin-Cap is
extremely effective against LP,( probably as effective against it as it is
against psoriasis!). I have tried it on about 10 cases and, without fail, it
has worked and given me some of the most happy patients. I recently tried
it on hypertrophic LP of the shins and in 3 weeks it worked like magic! (I
have before and after photos).BUTas I have recently posted, Skin-Cap was
found to contain clobetasol proprionate in the Netherlands!!! Please see
that post for details. We have not found steroids in the U.S. version,
although we did not look for c.p. specifically. We are now. I'll keep the
group posted.

Charles Crutchfield
------------------


Tried Skin Cap on a lady whose LP resisted EVERYTHING including
PUVA,Vesanoid, intralesional and topical corticosteroids and she's
greatlyimproved.I warned her that there are no studies, and no safety data.
She is willing toaccept potential unknown and unquantifiable risks.

Kevin C. Smith MD FRCPC
-------------------


Skin cap has been sold for a long time in Spain. Patients use it morethan
dermatologists. It¥s said that it contained a corticosteroid sometime ago,
but the formulation changed later. Dermatologists that haveused it for
some time say that it works the first times, but it shows atachyfilaxis
effect.

Ignacio G. Doval
------------------


The past 2 days I have seen 3 patients whose psoriasis no longer responds
toSkin Cap Spray. These were all initially dramatically responsive. They
haveused it 6-8 weeks. Sounds like tachyphylaxsis in these
uncontrolledobservations.

Philip Hughes, M.D.
------------------


I have one tachyphylaxis out of about 30 Skin Caps that I know of.

Guy Webster
------------------


This is the other shoe everyone has been waiting to drop. So far my
100+patients on Skin-Cap have not noted tachyphylaxis, but I was
veryinterested in the comments of the Spanish dermatologist in this
regard.I'd love to hear of similar cases, and will post if mine find this too.

Mark Ling, M.D., Ph.D.
------------------


I have also seen Skin Cap Spray tachyphylaxis. Perhaps the role of Skin
Cap Spray (SCS) will ultimately be as a adjuvant to ultraviolet light as
the SCS quickly clears the opaque scale of psoriasis.

Rhett Drugge, M.D.
------------------


After distributing 2 cases of skin cap my anecdotal experience I about
75% response. Thick plaque and scalps the best, hands the worst. So far
notachyphylaxis but because of prior po stings I am expecting it.
Allerganrep was introing tazarotene and made reference to rumors of
toxic productsin skin cap--is this going to be the drug co's defence
instead of ascientific analysis? It seems somewhat magical for some of
the patients.

L.J. Gregg,M.D.,
------------------


Here at the Canadian Derm meeting in Newfoundland there's lots of talk
andspeculation about Skin Cap. A lot of people have stories about
wonderful andvery rapid responses, including discoid lupus, lichen planus,
intertrigo,perianal dermatitis, and inflammatory acne (a week before the
Prom).Several have mentioned that Dr. Crutchfield, his derm department
and U. of MNare being sued or threatened with a lawsuit by the US
distributors of SkinCap, perhaps because they tried to make a copy of Skin
Cap. What are thefacts, and will this affect the publication of the results
of Curtchfield'scurrent large study on Skin Cap?I wonder if Skin Cap,
which may be the most potent topical anti-inflammatorythe world has
ever seen, would be useful for contact dermatitis (eg. poisonivy), vitiligo
or alopecia areata.Does anyone know of a medication as potent as Skin Cap
which is devoid ofside effects? I'll bet that in the fullness of time
problems will bereported. At this meeting are several mentions of striae
and hypertrichosis

KC Smith MD FRCPC
--------------------


I did clinical trials of terbinafine in onychomycosis for Sandoz. One of
ourrecorded Adverse Drug Reactions was a florid case of tinea
versicoloronsetting, if memory serves, after about two-four weeks on
terbinafine. Ibelieve (but cannot prove because M. furfur is everywhere)
that if you havepsoriasis *and* you are allergic to your M. furfur
population - terbinafinewill trigger psoriasis through the intermediary
reaction.

Bill Danby
--------------------


At the Canadian Derm there was discussion about our liability
forrecommending Skin Cap, in view of the fact that it is a VERY potent
topicalbroad-spectrum anti-inflamatory and perhaps immunosuppressive.
Othermedications which are as potent or even less potent (eg.
clobetasolproprionate) can cause serious side effects, and it is thought
likely thatwhen long-term safety and efficacy data becomes available
problems with SkinCap will emerge. (Sort of like the way we are now
seeing serious problemsemerge with the "Fen-Fen" drug combination for
obesity.)In the case of Skin Cap, we do not have data from the usual basic
science,animal work, Phase I, II, and III studies, and post-marketing
surveillancethat we are accustomed to with virtually all of the other
drugs and physicalmodalities that we use in dermatology.In addition, the
distributors of Skin Cap have showed no interest inproviding this type of
data, and have been evasive and un-cooperative.In spite of all of the above,
we are responsible (and probably liable) forour recommendations with
regard to Skin Cap, just as we are for any otheradvice we give.In the case
of Skin Cap, we do not have the control associated with aprescription
medication, because we cannot cut off the supply of medicationif we think
it should be stopped. The patient can purchase Skin Cap over thecounter,
but we are still liable (even though we don't have control) if
werecommended Skin Cap.It was suggested that we make up some sortof
"Skin Cap information and consent form", which would bring the
aboveissues to the patient's attention, and make clear the extent (if any)
towhich we take responsibility for their use of Skin Cap and for
theconsequences which may flow from that. This might also help the
patientsunderstand why we are reluctant to recomend Skin Cap, or to take
theassociated responsibility for its use. Here is my first draft, for
yourcomments and additions:"Skin Cap information and consent

"FOR: (patient name) DATE: __________Skin Cap is a VERY powerful
broad-spectrum anti-inflamatory and perhapsimmunosuppressive
combination of chemicals which can be applied to the skin.Other
medications which are as potent or even less potent (eg.
clobetasolproprionate - Temovate, Dermovate) can cause serious side
effects such asthinning ofthe skin, excessive hair growth and sometimes
crippling problemswith the bones and joints and other body systems. We
do not know whatproblems may develop after long-term (or in some cases
even short-term)exposure to Skin CapIn the case of Skin Cap, we do not
have data from the usual basic scienceresearch, experiments on animals,
or research studies on humans, andfollow-up research that we are
accustomed to with virtually all of the otherdrugs and other treatments
that we use in dermatology. None of the othertreatments we use in
dermatology have "secret ingedients" of the sort claimedfor Skin Cap.In
addition, the distributors of Skin Cap have showed no interest inproviding
this type of safety and effectiveness data, and have been evasiveand
un-cooperative.In spite of all of the above, I am responsible (and probably
liable) for myrecommendations with regard to Skin Cap, just as I am for
any other advice Igive you.In the case of Skin Cap, I do not have the control
associated with aprescription medication, because I cannot cut off the
supply of medication ifI think it should be stopped. You can purchase Skin
Cap over the counter, butI may liable (even though I don't have control) if I
recommended Skin Cap.For these reasons, I am making a record in your
chart that I am NOTrecommending Skin Cap in your case. If you decide to
accept the uncertain andpossibly serious problems which could be
associated with using Skin Cap Iwill be happy to continue helping to take
care of your skin problems, but Iwill not accept responsibilty for any
problems Skin Cap causes you. YOU SHOULD NOT USE SKIN CAP if you are
not willing to accept the risks andproblems (including risks and problems
we are not aware of yet) which couldbe associated with using Skin Cap.If
you decide to use Skin Cap, please keep a diary of when you start and
stopusing Skin Cap, the amounts you use, the other medications and
treatments youuse in addition to Skin Cap, and the areas you apply it to.
Please keep me informed of your progress. If you have problems related
toSkin Cap please let me know and I will try to help you. Once again I
remindyou I AM NOT RECOMMENDING THE USE OF SKIN CAP, AND I DO NOT
ACCEPT ANY RESPONSIBILITY FOR ANYTHING (GOOD OR BAD) THAT COMES
FROM YOUR USE OF SKINCAP.

KC Smith MD FRCPC
--------------------


Even with your concerns, it does not have to be couched in this manner.
What I dislike most about it is that you are actually
recommendingsomething to a patient while telling them that you are not
reallyrecommending it- so as to avoid any responsibility.I share my
concerns with patients verbally and document the conversation. I tell
them I do not know all the substances in Skin Cap and that I can nottell
them anything about possible future dangers. I also tell them thatthis is
indeed amazing stuff, but should be used carefully. I have even hadsome
patients buy respirators (painting filters) at the hardware store sothey
don't have to breathe fumes when applying it. I promote the use of Skin
Cap because so far it seems safer than lots ofthe internally applied meds,
and more effective than most topical ones.I document my notes as to the
discussion.

Jerry Eisner
--------------------


Re the FDA status of Skin Cap:based on my personal understanding as well
as conversation with Dr. J.Wilkins at the FDA Liaison Task Force meeting
at the Academy meeting, itis my belief that Skin Cap is not in any
effective manner "FDA-approved,"despite advertising to that effect. It is
currently marketed OTC based onthe listing of zinc pyrethione as the
active ingredient. Any product usingzinc pyr. as its active can make claims
that it is generally recognized assafe and effective for seb derm/dandruff
(but NOT for any other conditionincluding psoriasis, again despite at least
one distributor's advertisingto the contrary). The big question is that
given the extraordinary efficacy of this productthere is the possibility
that this still needs to be regarded as a newdrug, and thus would
necessitate filing of an NDA with all the attendantclinical testing. Of
course, since the product is not patented, I suspectthat the manufacturer
would never foot the multimillion dollar cost offiling an NDA, and thus
may lead to a strange situation where Skin Capbecomes an illegal drug.
We'll see: I suspect the FDA will make a decisionin the next year.

Mark Ling, M.D., Ph.D.
--------------------


I had a patient appear in my office three weeks ago with
erythrodermicpsoriasis. The story was that he had mild plaque psoriasis
for many yearsand had controlled himself with OTC tar and other
preparations. He is in hislate sixties and prior to a trip from Rochester,
NY, to "the middle ofnowhere," Tennessee, he had experienced a mild flare
up of the disease butduring his stay with relatives down there he had
flared terribly and had indesperation driven himself back home. When I
saw him, he had 70% of the bodycovered with erythrodermic psoriasis. I
started him on Soaks andtriamcinolone ointment after noting to him that
he had significant evidenceof stasis change on the lower legs and
extracting from him a history of theproblem starting to flare on the legs
suggestive that the long trip hadflared an underlying stasis tendency as
the cause of the psoriatic flare. Hereturned partially improved in one
week and I gave him a single dose of MTXto attempt to "cool off" the still
persistent areas on the legs. He was muchbetter on the third visit and
decided to forego the second dose of MTX. Thisweek (two days ago) he
returned with a significant flare up of one arm andsheepishly told me that
prior to leaving for Tennessee he had purchased a canof Skin Cap spray
OTC at the suggestion of a friend and was using it for thesmall flare that
started prior to his trip. He continued to use it down inTennessee even
when he began to flare. On his return to Rochester he hadstopped the Skin
Cap when he came to me and started on the soaks andtriamcinolone but
after he had improved he tried the Skin Cap on the one armand had
experienced a terrible flare there over the next twenty-four hours. I've
seen a number of dramatic responses to the Skin Cap and this is thefirst
dramatic side effect.

Pat Condry
--------------------


Excellent. Much less self-defensive. Very informative for the patient.
Furthermore, your attempt has given me the stimulus to try some ideas
for a form of my own. I would like permission to borrow some of your
ideas. I have only two suggestions for your form which I have included
below. I remove the categorical statements about Skin Cap's power, since
we admittedly do not know how it works - remember, it just might be
quite benign compared to some of what we already use. Penicillin was
once a radically powerful drug against bacteria, and except for severe
allergy, has little physiological effect.----

Jerry Eisner
--------------------


Excellent. Much less self-defensive. Very informative for the patient.
Furthermore, your attempt has given me the stimulus to try some ideas
for a form of my own. I would like permission to borrow some of your
ideas. I have only two suggestions for your form which I have included
below. I remove the categorical statements about Skin Cap's power, since
we admittedly do not know how it works - remember, it just might be
quite benign compared to some of what we already use. Penicillin was
once a radically powerful drug against bacteria, and except for severe
allergy, has little physiologicaleffect.

Jerry Eisner

--------------------


Here in Brasil we have the same trade mark : "Skin Cap" in shampooand
spray ( that contains Zinc Pyritione ) and a lot off pacients areusing by
their owns for Psoriasis, because they can buy it very easily. We don't
have yet serious studies about this product and in fact I'mafraid of using
it.

MARILUCE D. MOLL , MD.
--------------------


"the medicine is FDA approved, or at leastit is not disapproved. Thus,
legally, the medicine can be used withsome modicum of safety."I love
Dr.Smith's analogy of fuel oil and fertilizer also being safe independently
and unsafe when mixed. OTC products do not give the same assurances of
safety as prescription drugs. The FDA says that in general, Zinc pyrithione
is safe in certain concentrations. Companies can then market it in those
concentrations without any study of their product's safety. Noone may
know if the actual formulation, with whatever so-called inactive
ingredients, is safe because there could be unknown interactions between
the active ingredient and the inactives.In the US, one guarantee of safety
is the reputation of the manufacturer. When you buy Tylenol brand
acetominophen from the McNeil/J&J, you know it's going to be safe. They
have a lot to lose if it isn't. Do you think you have the same degree of
assurance when buying Skin Cap? I don't.When the product is as potent as
some here are finding, there must be something going on. It concerns me.
I relay that concern to patients thinking about using the product and am
very reluctant to recommend the product as that would give the patient
the impression of safety (based on my good reputation instead of the
company's [perhaps this is the safety equivalent to my concerns about
efficacy when recommending an alpha hydroxy acid product]).Still, I agree
that a consent form is over doing it.(BTW, I asked one of the toxicologists
at the local cigarette company to do a toxicology study on some Skin Cap.
I put some in a plastic tube for him. He picked up the stuff and took it
back to his lab. Unfortunately the stuff ate through the plastic before he
could study it. The solvent must not have been compatible with the
plastic. We'll try again tomorrow with a glass container.)

Steve Feldman, MD
--------------


Thanks to all who helped with the refinement of my Skin Cap Info Sheet.
Hereis the final version, which should contribute to the informed consent
processand at the same time reduce the risk of misunderstandings that
could lead to litigation:"Skin Cap information sheet

"FOR: (patient name) DATE: __________
Recently some patients have been asking about a product called Skin Cap
(andabout some other similar products). I have prepared this information
sheet tohelp you decide whether or not you are willing to accept the risks
andproblems which could be associated with your decision to use Skin
Cap.Skin Cap is a mixture of chemicals including methyl ethyl sulfone
(also knownas isopropyl myristate) and zinc pyrethrone. The individual
chemicals (methylethyl sulfone and zinc pyrethrone) are considered to be
reasonably safe whenapplied to the skin, but the risks of applying the
mixture of chemicals soldas "Skin Cap" are unknown.Skin Cap appears to be
a VERY powerful broad-spectrum anti-inflamatory andperhaps
immunosuppressive combination of chemicals which can be applied tothe
skin. Skin Cap seems to reduce inflammation in a number of unrelated
skinconditions, including psoriasis, lupus, and lichen planus. Other
medications which are as powerful as Skin Cap or even less powerful(eg.
clobetasol propionate - Temovate, Dermovate) can cause serious
sideeffects such as thinning of the skin, excessive hair growth, and
occasionallymay even cause crippling problems with the bones and joints
or other bodysystems if not used properly. Medications which are as
powerful as Skin Capgenerally have the ability to cause serious problems
under somecircumstances.Because Skin Cap is not a prescription medicine
we do not have informationfrom the scientific studies, experiments with
animals, or experiments withhumans which are available for virtually all
of the other medicines and othertreatments that we use in
dermatology.Because medical and scientific information on Skin Cap is not
available:1. We do not know how Skin Cap works.2. We cannot predict what
kinds of problems may develop after long-term (orin some cases even
short-term) exposure to Skin Cap. 3. We do not know if there is a safe
limit to the amount of Skin Cap whichcan be applied every day.4. We do not
know if there is a safe limit to the number of days or weeksSkin Cap can
be applied.5. We do not know if there are some parts of the body where
Skin Cap shouldnot be applied. 6. We do not know if Skin Cap might make
some diseases worse (for exampleskin infections or skin cancer).7. We do
not know if there are some people (for example children, pregnantwomen
or old people) who may be at increased risk for problems if they
areexposed to Skin Cap.Because Skin Cap is not a prescription medicine, it
is not required to bemanufactured to the same high standards we expect of
prescription medicines,and the manufacturer of Skin Cap may deliberately
or accidentally change the amounts and types ofchemicals in Skin Cap
without telling anyone.Because there are a number of unanswered
questions and unknown risks mostpeople prefer to avoid using Skin Cap for
the time being, but there are a fewpeople with very bad skin conditions
which are not reponding adequately toordinary treatment, and in some of
these cases people are willing to acceptthe possible risks and unknowns
associated with using Skin Cap.YOU SHOULD NOT USE SKIN CAP if you are
not willing to accept the risks andproblems (including risks and problems
we are not aware of yet) which couldbe associated with using Skin Cap.If
you decide to use Skin Cap, please keep a diary of:1. when you start and
stop using Skin Cap2. the amounts of Skin Cap you use3. the other
medications and treatments you use in addition to Skin Cap4. the areas you
apply Skin Cap to. 5. The lot number (printed usually on the bottom of the
can), in case thereare changes from batch to batch in the mixture of
chemicals in Skin Cap.Please bring this diary when you come to see me, so
I can take it intoaccount when I am working with you.When you return for
followup visits please keep me informed of your progress.If you have
problems which might be related to Skin Cap please let me knowand I will
try to help you.

KC Smith MD FRCPC
-------------------


As I pointed out, the good news about Skin Cap is that: "Skin Cap seems
toreduce inflammation in a number of unrelated skin conditions,
includingpsoriasis, lupus, and lichen planus." I have no doubt that Skin cap
isEFFECTIVE in many cases, and I have seen patients respond remarkably
well toit. My concerns are related to short term (weeks to months) and
long-term (monthsto years) adverse effects. I think that it is very
important for my patientswho are considering Skin Cap to be aware of the
many issues concerning thesafety of Skin Cap which have not been dealt
with yet. Basically, thisinformation sheet is an attempt to help them
cover THEMSELVES, and minimizeTHEIR risks, because if Skin Cap related
problems develop THEY will be theones who suffer.Zinc pyrithione as a
single agent is relatively benign (and relativelyimpotent) when applied to
the skin. The comparison of Skin Cap with the zincpyrithione in Head and
Shoulders is misleading. Skin Cap is a mixture ofchemicals, and the effect
of this mixture is completely different from theeffect of zinc pyrithione
when it is used as a single agent.Skin Cap appears to be AT LEAST AS
POTENT AS THE MOST POTENT TOPICAL STEROID CREAMS, and I am
suggesting that generally in medicine potent medications can also cause
serious side effects in some cases. I listed as an example of this some of
the problems steroid creams can cause, and I am suggesting that Skin Cap
MAY eventually be found to cause equally serious (but perhaps different)
side effects. The information that patients and physicians require in order
to make informed decisions about the safety of Skin Cap is not available.
Because the safety of Skin Cap is unknown, it is not possible to accurately
weigh the risks against the benefits.It is important for people considering
the use of Skin Cap to be aware of vast lack of information about Skin
Cap.I am comparing medications in terms of their clinical effects, not in
termsof their chemical composition.I would be very reluctant to prescribe
a medicine with so many unanswered questions, and I certainly reluctant
to recommend Skin Cap until safety data (comparable in quality to data on
the other equally potent medications I prescribe) is available. The short
reports in the Online Journal of Dermatology and in the Journal of
Geriatric Dermatology fall far short of meeting my needs (and the needs of
my patients) for safety data. It is correct that the formulation of Skin Cap
has been changed from time to time by the manufacturer, and some
formulations of Skin Cap have been banned in some countries in Europe
after being found to contain corticosteroids (and the presence of
corticosteroids was not disclosed on the label). The company now claims
that the presence of corticosteroids was an "accident". Such sloppy
manufacturing practices, and lack of final quality control, are
unacceptable for products seeking my recommendation.With regard to ASA
- we know a lot about how ASA works, and we also know a lot about ASA's
risks, interations with other treatments, indications for use and
contraindications. If I had as much information about Skin Cap as I have
about ASA I would be much more comfortable recommending Skin Cap to
my patients.I got some email from Dr. Crutchfield a couple of days ago. Dr.
Crutchfield has terminated his relationship with the distributors of Skin
Cap. The study he is working on will be completed in the Fall, and may be
published some time in 1998. The issues of long term safety and of
adverse interactions of Skin Cap with previous or concurrent treatments
will not be addressed in that study

.KC Smith MD FRCPC
--------------------


"Skin Cap information and consent
"FOR: (patient name) DATE: __________
Recently some patients have been asking about a product called Skin Cap
(andabout some other similar products). Skin cap can be very effective
incontrolling a number of unrelated inflammatory skin conditions,
includingpsoriasis, lupus and lichen planus. I have prepared this
information sheet tohelp you decide whether or not you are willing to
accept the risks andproblems which could be associated with using Skin
Cap.Skin Cap is a mixture of chemicals including zinc pyrithione and
possiblyalso sodium methyl ethyl sulfate and / or isopropyl myristate. The
individualchemicals (zinc pyrithione, sodium methyl ethyl sulfate and
isopropylmyristate) are considered to be reasonably safe when applied to
the skin. Thesafety of this MIXTURE of chemicals is unknown.Some people
think that because Skin Cap has "the same active ingredient asHead and
Shoulders Shampoo (zinc pyrithione) it is as safe as Head andShoulders ..."
This may not be a safe assumption. In the same way that relatively benign
things like ammonium nitratefertilizer and fuel oil can be mixed to create
an explosive, so it ispossible that sodium methyl ethyl sulfate and zinc
pyrithione have beencombined to produce a very potent medication with
properties and riskscompletely different from the individual
components.The beneficial effects of Skin Cap are very different from and
much greaterthan the effects produced by other zinc pyrithione containing
products, andit is possible that Skin Cap may turn out to produce harmful
effectsdifferent from and greater than those caused by other zinc
pyrithionecontaining products. Skin Cap appears to be a VERY potent
broad-spectrum anti-inflamatory andperhaps immunosuppressive
combination of chemicals. Medications which arevery potent generally
also have a greater ability to cause serious problems. Other medications
which are as potent as Skin Cap or even less potent (eg.clobetasol
propionate - Temovate, Dermovate) can cause serious side effectssuch as
thinning of the skin, excessive hair growth and occasionally may
evencause crippling problems with the bones and joints or other body
systems ifnot used properly. It is certainly possible that when more
information isavailable Skin Cap will be found to cause equally serious
(but perhapsdifferent) problems in some cases.Some people think that
because "tens of thousands of cans of Skin Cap arebeing sold every month,
and there has been little news of problems, Skin Capmust be pretty safe."
This may not be a safe assumption.Because Skin Cap is not a prescription
medicine the manufacturer anddistributor are not required to maintain a
detailed record of reports ofadverse reactions to Skin Cap. Because animal
and human experiments andfollowup studies of the quality necessary for
prescription medicines have notbeen done, it is very likely that the
number, severity and kinds of adversereactions to Skin Cap have not been
adequately identified and publicized.Because Skin Cap is not a prescription
medicine we do not have theinformation from the laboratory experiments,
experiments with animals, orexperiments with humans that are available
for virtually all of the othermedicines and other treatments that we use
in dermatology.Because medical and scientific information on the safety
of Skin Cap is notavailable:1. I do not know how Skin Cap works.2. I cannot
predict what kinds of problems may develop after long-term(months to
years) or in some cases even short-term (days to months) exposureto Skin
Cap in your case. 3. I do not know if there is a safe limit to the amount of
Skin Cap which canbe applied every day.4. I do not know if there is a safe
limit to the number of days or weeks SkinCap can be applied.5. I do not
know if there are some parts of the body where Skin Cap shouldnot be
applied. 6. I do not know if Skin Cap might make some diseases worse (for
example skininfections or skin cancer).7. I do not know if there are some
people (for example children, pregnantwomen, or old people) who may be
at increased risk for problems if they areexposed to Skin Cap.8. I do not
know if there could be an increased risk of problems (forexample, skin
cancer) if Skin Cap is used in combination with or followingother
treatment, such as ultraviolet light, methotrexate, cyclosporine
orcorticosteroid creams.9. I do not know if inhaling traces of Skin Cap
while it is being sprayed, orabsorbing it though the skin, could cause
internal problems. For example, itis possible that the potent
anti-inflammatory and possibly immunosuppressiveeffect of inhaled Skin
Cap could increase the risk of yeast infections in themouth and airway,
and perhaps also increase the risk of dangerous lunginfections like
Pneumocystis carinii. The animal and human experiments whichare
necessary to deal with these issues (and which would have been requiredif
Skin Cap was a prescription medication) have not been done.Because the
risks of Skin Cap are unknown, it is not possible to accuratelyweigh the
risks against the benefits.Because Skin Cap is not a prescription medicine,
it is not required to bemanufactured to the same high standards we expect
of prescription medicines,and the manufacturer of Skin Cap may
deliberately or accidentally change theamounts and types of chemicals in
Skin Cap without telling anyone.Because there are a number of unanswered
questions and unknown risks most ofmy patients prefer to avoid using
Skin Cap for the time being. There are afew people with very bad skin
conditions which are have not respondedadequately to better understood
treatments, and some of these people arewilling to accept the possible
risks and unknowns associated with using SkinCap. If you decide to use
Skin Cap, please keep a diary of:1. when you start and stop using Skin
Cap.2. the amounts of skin Cap you use.3. the other medications and
treatments you use in addition to Skin Cap 1.when you start and stop using
Skin Cap.4. the areas you apply Skin Cap to. 5. The lot number (printed
usually on the bottom of the can), in casethere are changes from batch to
batch in the mixture of chemicals in SkinCap.Please give me a copy of this
information when you come to see me, so I cantake it into account when I
am working with you.Please keep me informed of your progress, If you
have problems related toSkin Cap please let me know and I will try to help
you. YOU SHOULD NOT USE SKIN CAP if you are not willing to accept the
risks andproblems (including risks and problems we are not aware of yet)
which couldbe associated with using Skin Cap.

KC Smith MD FRCPC
--------------------


Thanks for the information about the chromatographic analysis of Skin
Cap.It still doesn't explain the spectacular results which I've been
personally seeing in the chronic psoriatics who have been using the
product.I've used super-potent steroids, and other high potency steroids,
under occlusion, and in every other way imaginable, and never saw results
like I'm presently seeing. There must "be something else" which is
responsible.I'm telling my patients that I don't know what's in Skin Cap,
that we don't know about any long term side effects, and we have no
information about rebound. I tell them of the results in other patients,
and then tell them they can try it if they like. When I mention the product,
they've virtually all heard about it, and many were already using it. I've
recently seen it in a mail order catalogue.Despite our concerns many of
the patients remain thrilled, and wish to keep using the product.The final
disposition will be interesting for all concerned!Robert I.

Rudolph, M.D., FACP
--------------------


I'll reiterate that my patient/scientist did blind analysis and found
Nosteroid, only zinc pyrithione and isopropyl myristate. He took can Igave
him and gave it to a colleague w/ psoriasis who has had usualresponse (he
love it). This IS a bad problem, as we like to know whythings work. I tell
patients I'm really tired of people telling me itworks so well, but they
keep telling me and I'd be remiss if I didn'toffer them skin cap as an OTC
option. I think company may haveproblems re: honesty, but I agree w/
comment below that says steriodsalone just not as good, so why would it
work this way here. I agree w/Rhett that psoriasis centers need to
respond to our need to understandthis highly effective topical agent.
Eliot--

Eliot N. Mostow, MD
--------------------


(Changes marked with ***).***"Skin Cap Lack-of-Information Sheet"
***FOR: (patient name) DATE: __________***
Recently some patients have been asking about a product called Skin Cap
(andabout some other similar zinc pyrithione-containing products). Skin
Cap canbe very effective in controlling a number of unrelated
inflammatory skinconditions, including psoriasis, lupus and lichen planus.
There are manythings which we will need to learn before Skin Cap can be
safely recommended.I have prepared this "lack-of-information" sheet to
help you decide whetheror not you are willing to accept the risks and
problems which could beassociated with using Skin Cap.Skin Cap appears
to be a VERY potent broad-spectrum anti-inflamatory andperhaps
immunosuppressive or immune-modulating medication. Medications
whichare very potent often also have a great ability to cause serious
problemsunder some circumstances. Other medications which are as
potent as Skin Cap or even less potent (eg.clobetasol propionate -
Temovate, Dermovate) can cause serious side effectssuch as thinning of
the skin, excessive hair growth and occasionally may evencause crippling
problems with the bones and joints or other body systems ifnot used
properly. It is certainly possible that when more information isavailable
Skin Cap will be found to cause equally serious (but perhapsdifferent)
problems in some cases.Some people think that: "Because Skin Cap has the
same active ingredient asHead and Shoulders Shampoo (zinc pyrithione) it
must be as safe as Head andShoulders." This may not be a safe assumption.
Skin Cap contains extremely small particles of zinc pyrithione. This form
ofzinc pyrithione and the manner of application of zinc pyrithione in Skin
Capis very different from other zinc pyrithione containing products like
Headand Shoulders Shampoo, and the risks of using Skin Cap are
unknown.Because the particles of zinc pyrithione in Skin Cap are much
smaller thanthose found in other zinc pyrithione containing products the
zinc pyrithionein Skin Cap may be absorbed by the skin to a much greater
extent. Absorption of zinc pyrithione by the skin may also be greatly
increasedbecause Skin Cap is intended to be left on the skin all day
("put-on,leave-on"), while other zinc pyrithione containing products like
shampoos areintended to be put on, and then rinsed off after a couple of
minutes("put-on, wash-off"). Over the years various formulations of Skin
Cap have been marketed in Europeand more recently in North America. In
addition to zinc pyrithione, theseformulations have included a variety of
chemicals which are collectivelyreferred to in the pharmaceutical
industry as "penetration enhancers". Theseare chemicals which are used to
increase the absorption of medications likezinc pyrithione by your skin.
Because Skin Cap is not a prescriptionmedication the manufacturer of Skin
Cap is not required to let you know thenames of the other chemicals (for
example, the "penetration enhancers") inSkin Cap.It is likely that
extremely-small-particle zinc pyrithione and apenetration-enhancer
delivery system have been combined in a "put-on,leave-on" type of
productto produce a very potent medication -- Skin Cap --with properties
and risks completely different from previously availableforms of zinc
pyrithione.Policies which permitted the non-prescription marketing of
poorly absorbedlarge-particle zinc pyrithione-containing products for
application to theskin for a few minutes ("put-on, wash-off") may not be
appropriate for theform of zinc pyrithione being marketed as Skin Cap.The
anti-inflammatory effects of Skin Cap are very different from and
muchgreater than the effects produced by other zinc pyrithione
containingproducts, and it is likely that Skin Cap will eventually turn out
to produceharmful effects different from and greater than those caused by
other zincpyrithione containing products. Because the effects of Skin Cap
on skin diseases such as psoriasis, lupus andlichen planus are vastly
greater than and different from the effects of otherzinc pyrithione
containing products, and because the absorption of zincpyrithione from
Skin Cap by the skin is almost certainly MUCH greater, SkinCap should be
regarded as a NEW medicine by patients and physicians, andperhaps also by
the goverment agencies which deal with the safety ofmedicines. Some
people think that: "Because tens of thousands of cans of Skin Cap arebeing
sold every month, and there has been little news of problems, Skin
Capmust be pretty safe." This may not be a safe assumption.Because Skin
Cap is not a prescription medicine the manufacturer anddistributor are not
required to maintain a detailed record of reports ofadverse reactions to
Skin Cap. Because animal and human experiments andfollowup studies of
the quality necessary for prescription medicines have notbeen done, it is
very likely that the frequency, severity and kinds ofadverse reactions to
Skin Cap have not been adequately studied andpublicized.Because Skin Cap
is not a prescription medicine we do not have theinformation from the
laboratory experiments, experiments with animals, orexperiments with
humans that are available for virtually all of the othermedicines and other
treatments that we use in dermatology.Because medical and scientific
information on the safety of Skin Cap is notavailable:1. I do not know how
Skin Cap works.2. I cannot predict what kinds of problems may develop
after long-term(months to years) or in some cases even short-term (days
to months) exposureto Skin Cap in your case. 3. I do not know if there is a
safe limit to the amount of Skin Cap which canbe applied every day.4. I do
not know if there is a safe limit to the number of days or weeks SkinCap
can be applied.5. I do not know if there are some parts of the body where
Skin Cap shouldnot be applied. 6. I do not know if Skin Cap might make
some diseases worse (for example skininfections or skin cancer).7. I do
not know if there are some people (for example children, pregnantwomen,
or old people) who may be at increased risk for problems if they
areexposed to Skin Cap.8. I do not know if there could be an increased risk
of problems (forexample, skin cancer) if Skin Cap is used in combination
with or followingother treatment, such as ultraviolet light, methotrexate,
cyclosporine orcorticosteroid creams.9. I do not know if inhaling traces of
Skin Cap while it is being sprayed, orabsorbing it though the skin, could
cause internal problems. For example, itis possible that the potent
anti-inflammatory and possibly immunosuppressiveeffect of inhaled Skin
Cap could increase the risk of yeast infections in themouth and airway,
and perhaps also increase the risk of dangerous lunginfections like
Pneumocystis carinii. The animal and human experiments whichare
necessary to deal with these issues (and which would have been requiredif
Skin Cap was a prescription medication) have not been done.Because the
risks of Skin Cap are unknown, it is not possible to accuratelyweigh the
risks against the benefits.Because Skin Cap is not a prescription medicine,
it is not required to bemanufactured to the same high standards we expect
of prescription medicines,and the manufacturer of Skin Cap may
deliberately or accidentally change theamounts and types of chemicals in
Skin Cap without telling anyone.Because there are a number of unanswered
questions and unknown risks most ofmy patients prefer to avoid using
Skin Cap for the time being. There are afew people with very bad skin
conditions which are have not respondedadequately to better understood
treatments, and some of these people arewilling to accept the possible
risks and unknowns associated with using SkinCap. If you decide to use
Skin Cap, please keep a diary of:1. when you start and stop using Skin
Cap.2. the amounts of skin Cap you use.3. the other medications and
treatments you use in addition to Skin Cap 1.when you start and stop using
Skin Cap.4. the areas you apply Skin Cap to. 5. The lot number (printed
usually on the bottom of the can), in casethere are changes from batch to
batch in the mixture of chemicals in SkinCap.Please give me a copy of this
information when you come to see me, so I cantake it into account when I
am working with you.Please keep me informed of your progress, If you
have problems related toSkin Cap please let me know and I will try to help
you. YOU SHOULD NOT USE SKIN CAP if you are not willing to accept the
risks andproblems (including risks and problems we are not aware of yet)
which couldbe associated with using Skin Cap.

KC Smith MD FRCPC
--------------------


Zinc pyrithione as a single agent is relatively benign (and relatively>
impotent) when applied to the skin. The comparison of Skin Cap with the>
zinc pyrithione in Head and Shoulders is misleading for a number of
reasons. I recall somebody in the group sayinghe'd bought ZnP in bulk and
it was a cloudy precipitate with ZnP in particleslarge enough to be seen
under the microscope. If this is true then SC isnot like this (but the
earlier formulation of Derma Zinc was). So eitherthere isn't any ZnP in
there or it's in the form of smaller particles.One speculation about the
mystical electro/electrolytic/electrophoreticprocessing that the
company/distributors has claimed at various timesis that it uses
electrophoresis to separate out very small particles andthe large ones are
reprocessed in some way. At a guess bulk ZnP couldbe a waxy solid and
therefore difficult to create small particles bymilling because of
frictional heating. I guess spraying molten ZnP froma vapourizer into
water could do a better job, but with a wide rangeof particulate sizes. An
electrophoretic step could separate out thereally small ones and the
larger stuff could be sprayed again.*If* the ZnP is in the form of smaller
particles then its penetrationinto the skin may be a lot higher than normal
which leads to worriesabout toxicity.The company line on this one
(conversation between Owner Mr Santamartaand John Kender reported in
the group by John Kender) is that: Some or all of the mixture produced is
subjected to 96 hours of electric current, and that this "bioelectrical
process changes the polarity of the molecules".Make of that what you
will. It could be flim-flam to cover up secretingredients with no such
processing, it could be an electrophoreticstep or it could be true
electrochemistry generating a mix of unknowncontents.> Skin Cap appears
to be AT LEAST AS POTENT AS THE MOST POTENT TOPICAL> STEROID
CREAMS, and I am suggesting that generally in medicine potent>
medications can also cause serious side effects in some cases.Ummmm.
Steroids have the subtlety of a shot-gun. It's not beyondcredibility that
something which works in a more subtle and less potentway, directed at
the real cause of the problem, could have a similareffect. You can break a
glass by hitting it with a hammer, or by singingat just the right pitch. A
hammer will generally do more damage thansinging when used as an
offensive weapon.I think this is a tenuous conclusion to draw, although I
understand whyyou would wish to make the warning.> I listed as an
example of this some of the problems steroid creams can> cause, and I am
suggesting that Skin Cap MAY eventually be found to cause> equally
serious (but perhaps different) side effects. One that has been reported
(and I've had) is skin peeling when used onpalms of hands and soles of
feet.> It is correct that the formulation of Skin Cap has been changed from
time> to time by the manufacturer, and some formulations of Skin Cap
have been> banned in some countries in Europe after being found to
contain> corticosteroids (and the presence of corticosteroids was not
disclosed on> the label). The company now claims that the presence of
corticosteroids> was an "accident". Such sloppy manufacturing practices,
and lack of final> quality control, are unacceptable for products seeking
my recommendation.A history of the formulations that I've seen. When I
say can/box/leafletthese were as supplied to me by the UK distributor
over 6 months ago - Ido not know what they say currently. The brochure is
a recent one from theUS which was reported to the group by Christian
Tice.Abbreviations are as follows: ZnP Zinc Pyrithione SMES
Sodium methyl ethyl sulphate SLS Sodium lauryl sulphate IM
Isopropyl myristate Alc Alcohol Exc Excipients Prop
Propellent 45 yes Listed but of unknown quantity no not listed
q.s. Quantity sufficient - added to other listed ingredients to
dilute them to the stated quantities Brochure Journal Can
Leaflet Box DistribZnP 0.2% 0.2% 2mg/ml 2mg/ml
2mg/ml yesSMES no no no 1mg/ml 1mg/ml
yesSLS yes 0.1% no no no yesIM yes
yes no no no yesAlc yes no no no
no yesExc no no q.s. q.s. no noProp no
yes no no no no

Distributors at various times have stated that the stuff contains
ZnP,SMES, SLS, IM and alcohol though none have ever listed all those
ingredientsat the same time.> Skin Cap is a mixture of chemicals including
zinc pyrithione and possibly> also sodium methyl ethyl sulfate and / or
isopropyl myristate.And/or sodium lauryl sulphate which appears in some
formulations in thesame quantities as SMES. The IM may or may not be
part of the excipients.Is the term excipients in common medical or
pharmacological usage or isit something else they've made up?> The
individual chemicals (zinc pyrithione, sodium methyl ethyl sulfate and>
isopropyl myristate) are considered to be reasonably safe when applied
to> the skin.They are? John Kender could not find a supplier for SMES or
safety sheetsfor it. Related chemicals diethyl sulphate and dimethyl
sulphate areconsidered carcinogens and toxic. There is, however, strong
doubt thatthe name SMES is accurate by any widely-accepted chemical
namingconventions. The company's own statement on this via a
distributor, in thepast, was: Methyl ethyl sulphate sodium is a compound
developed by Cheminova in order to preserve the secret of the formula.
This is done to avoid the risk of the product being copied by our
competitors. Its structure is quite similar to lauryl sulphate sodium as
both have a chain of methylic groups attached to a sodium sulphate salt.
This type of substance has tensioactive and antiseptic properties as
well as being keratolitic, helping Zinc Pyrithione act against skin
disorders and heal the skin.MESS (they like shuffling the elements around)
is a lot smaller than SLSand it's a big stretch of the imagination to call
them similar even ifthey are homologues.What John Kender did find, after
about a year of searching, was a chemicalwhich fit that description very
well indeed in terms of physical properties,biological properties and
similarity to SLS. This is Tergitol 4 which isinjected into varicose and
spider veins and causes an immediate blood clotand the filing on of the
vein with fibrous scar tissue. Since P requiresabnormal surface
capillaries to support it and this stuff could conceivablypenetrate into
surface capillaries it could well be very useful in treatingP.This chemical
is acutally an isomer of isopropyl myristate and a lot closerto sodium
lauryl sulphate than MESS is. One name for it issodium
2-methyl-7-ethylundecyl sulfate-4.^^^^^^ ^^^^^^ ^^^^^ ^^^^^^^> The safety
of this MIXTURE of chemicals is unknown.As far as some of us are
concerned, the actual formulation is unknown.Certainly something in there
caused the leaflet I have to carry thesewarnings: WARNINGS: Avoid
contact with the eyes. If this happens wash immediately with plenty
of cold water. SIDE EFFECTS: Allergic reactions may occur.
POISONING AND TREATMENT: Acute poisoning due to accidental
swallowing: anorexia, anaemia, vomiting. Treatment: stomach
washout with saline purgative.Some of those things make a lot more sense
if you assume that Tergitol 4is in there. Or maybe was in there. It
depends if you believe that theydropped SMES from the ingredients or
simply stopped listing it.> Some people think that because Skin Cap has
"the same active ingredient as> Head and Shoulders Shampoo (zinc
pyrithione) it is as safe as Head and> Shoulders ..." This may not be a safe
assumption. Not even if that's the only ingredient in their other than
alcohol. Becauseif it is in there at all it's at a much smaller particle size
than normalZnP. Toxicity data for ZnP is based on the normal particle size
which isunlikely to penetrate the skin.> In the same way that relatively
benign things like ammonium nitrate> fertilizer and fuel oil can be mixed
to create an explosive, so it is> possible that sodium methyl ethyl sulfate
and zinc pyrithione have been> combined to produce a very potent
medication with properties and risks> completely different from the
individual components.You forgot the
electro/electrochemical/electrophoretic processing. 96hours of
electrical zapping in some unspecified way or another which issupposedly
essential to the process.> Because medical and scientific information on
the safety of Skin Cap is> not available:> > 1. I do not know how Skin Cap
works.Claimed mode of action is that it zaps a yeast. The same yeast
which hasbeen found to cause dandruff and of a related species to the one
whichcauses sebohrroeic dermatitis. There are some very convincing
med-lineabstracts which indicate that this yeast is a causative factor and
that P isan immunological response to a infectious agent which the body
cannot getrid of rather than an auto-immune disease. Some of them are
realsmoking-gun material (I can mail you copies of the abstracts if you
haven'tseen them).There was also an interesting article in Science &
Medicine Nov/Dec 96about various arthropathies in which the authors
didn't quite committhemselves to saying that many arthropathies thought
to be auto-immunediseases are either hyper-immune responses to trace
levels of infectionor ordinary immune responses to undetected high levels
of infection. Theydo indicate that many more arthropathies may be
reactive than is currentlythought.> 2. I cannot predict what kinds of
problems may develop after long-term> (months to years) or in some cases
even short-term (weeks to months)> exposure to Skin Cap in your
case.*If* SMES turns out to be Tergitol 4 then the long-term effects of
theodd molecule from each session drifting around the bloodstream could
benasty for liver and kidneys.> 5. I do not know if there are some parts of
the body where Skin Cap should> not be applied.Palms of hands and souls of
feet are a good guess, at least in my experience.I ended up with 1/8"
thickness of dead skin on the soles of my feet attachedto raw pink new
skin in various places. On the palms of the hands I gotsub-millimetre
sized spots of what looked like P. With the palms I figuredthis was what
the company called `Rebellious P' and sprayed them more.The spots on the
palms grew in size and joined and eventually becamesimilar to the soles
of the feet in some ways. Stopping with SC in theseareas resulted in the
problems eventually going away.--Paul (Paul L. Allen)The following article
reveals the concerns of the dermatologist in Spainwho performed the
chromatographic analyses which led to the banning ofSkin Cap Spray from
Spain and subsequently the Netherlands. Skin CapSpray's European
experience has a track record poor enought to justify KevinSmith's
skepticism regarding its usage. I would hope that academic centerswhich
are studying psoriasis get to work on this evolving pharmacologic issue in
order to protect the public by providing studies which can evaluate
theefficacy and safety of exclude the use of Skin Cap Spray. Certainly
theissue of safety is not to be trusted to the manufacturer.

Rhett Drugge, M.D.
--------------------

Dear Dr. Drugge:>>I read in the last issue of Dermatolgy Online Journal an
article entitled>"The Highly Effective Use of Topical Zinc Pyrithione in the
Treatment of>Psoriasis: A Case Report=2>Charles E. Crutchfield III, M.M.B.,
M.D., Eric J. Lewis, M.D., Ph.D., and>Brian D. Zelickson, M.D>Dermatology
Online Journal: 3(1) : 3 ">I am writting to you as Editor of this Journal
because I cannot contact>directly with the authors of this article. I would
like tell that the>product tested in this article is a recently introduced in
USA>antipsoriatic OTC agent named Skin Cap.>Skin Cap was introduced in
Spain 5 years ago and was suposedly only Zinc>Pyrithione in an spray.

As the authors of the DOJ did I was very surprised of the
espectacular>results of Skin Cap when I used this product in psoriatic
patients. I was>so surprised of the good result that I could=B4nt believe
that Skin Cap>contained only Zinc Pyrithione. For that reason I ordered an
cromatographic>analysis of a sample of Skin Cap. Cromatography was
performed in the>Department of Farmacology and Dermatology of the
General Hospital in>Valencia (Spain) (you may check this information with
Dr. Adolfo Aliaga.>Chairmen of the Department of Dermatology of General
Hospital. Avenida Tres>Cruces s/n zip code 46009. Valencia. Fax 34 6 386
29 70).>Cromatographic analysis showed that Skin Cap do not contain zinc
pirithione. Skin Cap was actually a combination of triamcinolone
acetonide>at 0,5%, neomicyne undecilinate at 2% and salicylic acid at 1%.
Sanitary>authorities of the spanish Gov. were advised of this irregularity
and Skin>Cap was prohibited in our country.

Two years after, a similar problem was detected in the Netherlands,
with>the same product. Skin Cap was then analized at TNO in Zeist
(Netherland)>Of course, the result of this analysis was the same than in
Spain. Skin cap>contained triamcinolone acetonide at high concentration.
(This information>can be cheked at>TNO Nutrition and Food Research
Institute>Postbus 360>NL-3700 AJ Zeist>phone +31 30 694 41 44>fax +31
695 72 24>e-mail Infofood@voeding.tno.nl)>>If Skin Cap is giving now so
good results on the USA, I would like call>attention that Skin Cap could
not contain only Zinc Pirithione as>previously was detected in several
countries in Europe.>>Please, put all this information in contact with the
article authors and>the rest of the DOJ editors.

Sincerely yours,

Onofre Sanmartin, MD. PhD
Dermatologist
Servicio de Dermatologia
Instituto Valenciano de Oncolog Eda

I read with interest Dr. Sanmartin's comments about the discovery of
triamcinalone at 0.5% in skin cap in Spain a few years ago (see below). I
appreciate him posting this information for us. I have 2 comments for the
group:Because of the rumors of triamcinalone in skin cap, we had skin cap
tested specifically for triamcinalone and hydrocortisone and found that it
contains neither. We are currenly evaluating it for the presence of
Temovate, (in light of the Netherlands findings). A few weeks ago the
producer of Skin Cap has sent me a fax that clearly states that "the U.S.
version of s cap has not, and does not contain any corticosteroid". In my
heart, I doubt that (U.S.) skin cap contains steroids. I truely believe that
the vehicle is making the big difference. Time will tell.Secondly, our
current (40-60 patient) vehicle controlled, double blind study evaluating
the topical use of zinc pyrithione to treat psoriasis was initiated almost
1 year ago when this formulation of topical zinc pyrithione was just
beginning to be noticed as a very effective treatemnt for psoriasis here in
the U.S.. In fact, our reports in the Dermatology Online Journal
(http://matrix.ucdavis.edu/Vol3num1/zinc/zinc.html) and J of Geriatric
Derm (5(1):21-24, Jan/Feb 1997) are the first peer-reviewed reports of
this preparation that we can verify, anywhere. At the time we designed
the study, our intent was very simple: To evaluate its effectiveness in a
controlled setting (i.e. to rule out a plecebo effect). As far as safety
issues, we are looking only at cutaneous side effects during the study
period. Long term and systemic safety questions must be addressed in
other studies. Our study is concluding next month and we will be
submitting the results for publication shortly thereafter. (I can report
that no participant has left the study due to adverse cutaneous side
effects). We will have a poster at the upcoming NY AAD (with histology
and electron microscopy), and I will be giving a talk at the National
Medical Association Annual Conference early this August.

Charels E. Crutchfield III, MMB, MD
--------------------


I admire your capability to maintain a sense of humor given how much
flak you've taken for the info sheet. I hope in my comments that Ididn't
come off negative or offensive - if so, that was NOT my intent.I really
think what you have done is very good, and this latest revisionlooks good
to me. Just so you can put me into perspective, I'm a 56year old PhD
chemist who has had mostly 'mild' (according to the NPF webpage)
psoriasis (1-3%, elbows, knees, scalp, ears, waist, small of theback,
chest, scrotum) for the last dozen or so years. Steroidal creams and
ointments have at best held things at bay. Mydoctor has run me past Lidex
(fluocinonide), Topicort (desoximetasone),Utravate (halobetasol
propionate) and of course, good ole'hydrocortisone. For the scalp, we have
tried several including Tegrin,Head & Shoulders, Nizoral (ketoconazole),
and on my own, I have recentlyfound that Neutrogena T/Gel extra strength
seems to have done the best.Given that, and the lack of local availability
to find SkinCap, andbeing aware of several other psoriacs who have had
some luck with coaltar, I have tried MG217, an over-the-counter from
Triton ConsumerProducts which contains 10% coal tar USP, or 2% coal tar.
Whilesomewhat greasy, it seems (after 5 days) to be helping.I found a
drugstore which CLAIMS it can get SkinCap in 2 days, but If Ican get away
with the coal tar, I'll stick with it for the time being.Keep up the good
work. Will you be gathering publishable data as aresult of your care? It
sounds like medically acceptable literature isstill scanty.Best regards,

Ralph Czerepinski
-------------------


For what its worth: I have a 3rd yr family practice resident rotatingthru
my office thesepast 2 weeks...it so happens he has fairly stable, but
widespread plaquetype psoriasis...He has in the past used mtx(describes
self as "mtxfailure"),usesa Jordan light box for home therapy.After a
discussion of skin-cap andreview of KC's info sheet,he agreed to a
pair-comparison-lt arm sites skin-cap,rt arm sitesdermazinc...after
approx 10 days both sides improved, " a lot", but weboth give the edge to
skin-cap.Also he notes no scent with skin-cap, buta distinct
"alcohol"scent with dermazinc.no irritation with either product.

Pierre Jaffe, MD
---------------------


Cheminova Internacional, S.A.Macarena 14C/. Felix Boix, 828036
MadridSpainFAX 350 92 92Teleph. 359 40 30 - 359 40 54

Annemette Oxholm
----------


At approx 2 weeks now, we both agree that the Skin Cap side has improved
even more compared to the Derma Zinc sites.No irritation with
eitherside.The skin cap site has no scaling and obviously resolving
erythema,where the dermazinc side has persistant but clearly decreasing
amounts ofscaling...the FP resident's comment,"Skin Cap is definetly
pulling away" .I'll f/u in a couple of weeks.

Pierre Jaffe, M.D.
---------------


One of my patients managed to get SkinCap spray from a London pharmacy
--incidentally in the UK it is NOT an OTC item. She used it for her
intractablechronic plaque psoriasis on her legs and it almost cleared.
Very impressive.However, she ran out a week ago. I saw her today. The
rebound is quite severe,and it reminds me of the rebound patients get with
superpotent topical steroids.I shall definitely be going to the archives to
look up Dr. K. Smith'sinformation sheet for patients on SkinCap!

Melinda Tong, MRCP
----------------


Skin Cap is just getting off the ground here. I had a patient in the other
daywho had tried it on her own, improved a bit, then had a terrible flare
(theworst she'd been in years).I've sent copies of my Skin Cap "LACK OF
INFORMATION" handout to all the localpharmacies, and I'm giving it to my
psoriasis patients as they come through,making it clear that this for
information and (except in rare cases) I am NOTrecommending Skin Cap.
The handout has been much appreciated by the patientsand pharmacies.I am
trying it for a few things like vitiligo and alopecia areata.I'm attaching a
copy of my handout. Feel free to use or modify it

.Kevin C. Smith MD FRCPC - Dermatology
--------------------

FOR: ___________________________ DATE: __________
Recently some patients have been asking about a product called Skin Cap
(andabout some other similar zinc pyrithione-containing products). Skin
Cap can bevery effective in controlling a number of unrelated
inflammatory skinconditions, including psoriasis, lupus and lichen planus.
Unfortunately thereare many things which we will need to learn before
Skin Cap can be safelyrecommended. I have prepared this
"lack-of-information" sheet to help youdecide whether or not you are
willing to accept the risks and problems whichcould be associated with
using Skin Cap.Skin Cap appears to be a VERY potent broad-spectrum
anti-inflammatory andperhaps immunosuppressive or immune-modulating
medication. Medications whichare very potent often also have a great
ability to cause serious problems undersome circumstances.Other
medications which are as potent as Skin Cap or even less potent
(eg.clobetasol propionate - Dermovate) can cause serious side effects
such asthinning of the skin, excessive hair growth and occasionally may
even causecrippling problems with the bones and joints or other body
systems if not usedproperly. It is certainly possible that when more
information is available SkinCap will be found to cause equally serious
(but perhaps different) problems insome cases.Some people think that:
"Because Skin Cap has the same active ingredient asHead and Shoulders
Shampoo (zinc pyrithione) it must be as safe as Head andShoulders." This
may not be a safe assumption:1. It is not known whether the zinc
pyrithione or the other chemicals in SkinCap is responsible for the very
potent anti-inflammatory effect of Skin Cap.Because Skin Cap is not a
prescription medicine the manufacturer is not requiredto tell anyone the
names of the other chemicals in Skin Cap.2. The anti-inflammatory
effects of Skin Cap are very different from and muchgreater than the
effects produced by other zinc pyrithione containing products,and it is
likely that Skin Cap will eventually turn out to produce harmfuleffects
different from and greater than those caused by other zinc
pyrithionecontaining products.3. Because the effects of Skin Cap on skin
diseases such as psoriasis, lupusand lichen planus are vastly greater than
and different from the effects ofother zinc pyrithione containing products
Skin Cap should be regarded as a NEWmedicine by patients and physicians,
and perhaps also by the goverment agencieswhich deal with the safety of
medicines.Some people think that: "Because tens of thousands of cans of
Skin Cap arebeing sold every month, and there has been little news of
problems, Skin Capmust be pretty safe." This may not be a safe
assumption.Because Skin Cap is not a prescription medicine the
manufacturer and distributorare not required to maintain a detailed record
of reports of adverse reactionsto Skin Cap. Because animal and human
experiments and followup studies of thequality necessary for prescription
medicines have not been done, it is verylikely that the frequency, severity
and kinds of adverse reactions to Skin Caphave not been adequately
studied and publicized.Because Skin Cap is not a prescription medicine we
do not have the informationfrom the laboratory experiments, experiments
with animals, or experiments withhumans that are available for virtually
all of the other medicines and othertreatments that we use in
dermatology. Because medical and scientificinformation on the safety of
Skin Cap is not available:
1. I do not know how Skin Cap works.
2. I cannot predict what kinds ofproblems you may develop after
long-term (months to years) or in some cases evenshort-term (days to
months) exposure to Skin Cap.
3. I do not know if there isa safe limit to the amount of Skin Cap you can
be apply every day.
4. I do notknow if there is a safe limit to the number of days or weeks
Skin Cap can beapplied.
5. I do not know if there are some parts of your body where Skin
Capshould not be applied.
6. I do not know if Skin Cap might make some diseasesworse (for example
skin infections or skin cancer).
7. I do not know if thereare some people (for example children, pregnant
women, or old people) who may beat increased risk for problems if they
are exposed to Skin Cap.
8. I do notknow if there could be an increased risk of problems (for
example, skin cancer)if Skin Cap is used in combination with or following
other treatment, such asultraviolet light, methotrexate, cyclosporine or
corticosteroid creams.
9. I do not know if inhaling traces of Skin Cap while it is being sprayed,
orabsorbing it though the skin, could cause internal problems. For
example, it is possible that the potent anti-inflammatory and possibly
immunosuppressive effectof inhaled Skin Cap could increase the risk of
yeast infections in the mouth andairway, and perhaps also increase the
risk of dangerous lung infections likePneumocystis carinii. The animal
and human experiments which are necessary todeal with these issues (and
which would have been required if Skin Cap was aprescription medication)
have not been done.Because the risks of Skin Cap are unknown, it is not
possible to accuratelyweigh the risks against the benefits.Because Skin
Cap is not a prescription medicine, it is not required to bemanufactured to
the same high standards we expect of prescription medicines, andthe
manufacturer of Skin Cap may deliberately or accidentally change the
amountsand types of chemicals in Skin Cap without telling anyone.Because
there are a number of unanswered questions and unknown risks most of
mypatients prefer to avoid using Skin Cap for the time being. There are a
fewpeople with very bad skin conditions which are have not responded
adequately to better understood treatments, and some of these people are
willing to accept the possible risks and unknowns associated with using
Skin Cap.You should not use Skin Cap unless you are willing to accept the
possible risks and side effects (including risks and side effects we are
not aware of yet.) If you decide to use Skin Cap, please keep a diary of:
1. when you start and stop using Skin Cap.
2. the amounts of skin Cap youuse.
3. the other medications and treatments you use in addition to Skin Cap1.
when you start and stop using Skin Cap.
4. the areas you apply Skin Capto.
5. The lot number (printed usually on the bottom of the can), in casethere
are changes from batch to batch in the mixture of chemicals in Skin
Cap.Please give me a copy of this information when you come to see me, so
I can takeit into account when I am working with you. Please keep me
informed of your progress, If you have problems related to SkinCap please
let me know and I will try to help you.

--------------------------------


How long was your patient using Skin Cap?Had she been on it for only a
short period, I wonder if the period before signsof reoccurrence would
have been longer than a week if the duration of therapywas longer. My
thinking is that reoccurrence following cessation of Skin Captherapy may
be similar to reoccurrence post coal tar treatment. It is myunderstanding
that the longer one treats with coal tar the longer the periodbefore
remission occurs after cessation of therapy and that duration of
therapymight be related to knocking out more of the 'activated cells'. The
duration ofSkin Cap therapy may or may not relate to the severity of
reoccurrence. Anythoughts from the others on the list?

Daniel Bucks PhD
The contents of this message are the opinion of the sender and do
notnecessarily reflect the opinion of Penederm Inc. or its management.
-----------------------


I have received several telephone calls today informing me that at the
AmericanAcademy of Dermatology Summer Meeting (New York) today,
Friday, August 1, 1997,Professor Mark Lewohl, Chairman of the
Department of Dermatology of Mt. SinaiSchool of Medicine announced, (in
his presentation on the new treatments forpsoriasis) that his department
had several cans of Skin Cap analyzed and theywere found to contain the
superpotent steroid "clobetasol proprionate" . Iwould assume that the FDA
and Federal Authorities are now being notified for theappropriate
actions.Has anyone else heard of this report by Dr. Lebwohl?

Dr. Crutchfield
--------------------


This, if confirmed, is obviously sad news for all of us who have been
seeingmarvelous results with this agent. Most of you will agree that
Temovate gelnever cleared stubborn psoriatic scalps like Skin Cap does.
The silver liningin the cloud is that now the mystery is solved, perhaps
one of our orthodoxpharmaceutical companies, maybe even Glaxo, will be
able to duplicate theformula and get the stuff FDA approved. I certainly
suspect it should bepossible to prove that this formulation is more
effective than other forms ofclobetasol currently on the market, and if
Tazorac can get away with $200 a tubepricing, then there is clearly money
to be made in this arena once the insurancecompanies are in the
prescribing loop.

Mark Valentine
---------------


Even if the FDA were to "crack down" on Skin Cap spray, we might
considercontinuing to evaluate similar agents. Many of us have remarked
in the pastthat skin cap spray is more effective than high potency
glucocorticoidpreparations. Perhaps there is a synergistic effect between
the glucocorticoidand the zinc pyrethione. What are the in vitro effects of
the combination? Hasanyone tested the combination of these agents to
inhibit a lymphocytephytohemaglutinin stimulation assay?

Rhett Drugge, M.D.
-------------


I do not think we should assume the report of clobetasol in Skin Cap is
accurateuntil confirmed. Sorry, but its still unsubstantiated rumor, even
though we gotto read about it on the Internet.

Jerry Eisner
-----------

The penetration enhancers like isopropyl myristate would probably help
theactive ingredient in Skin Cap get into the skin; and in addition: as
thevehicle evaporates the concentration of residual drug in the Skin Cap
layerwould increase greatly, increasing the concentration gradient driving
drug intothe skin.

Kevin C. Smith MD FRCPC
----------------


The rumor that Skincap contains clobetasol is confirmed----I spoke
briefly withDr. Mark Lebwohl who confirmed this finding at the summer
AAD meeting.For those who are not familiar with him, Dr. Lebwohl is the
Chairman ofDermatology at Mt. Sinai Medical Center in New York City and
has extensiveresearch experience in psoriasis, among other areas of
interest.There was no time for elaboration and I have no additional
information.

Stephen L. Comite, MD
---------------


Perhaps this is one of the reasons that several have noticed an
acneiformeruption on the face, either acne or perioral dermatitis? The
isopropylmyristate as well could cause an irritant acne.

Diane Thaler
--------------


isopropyl myristate is comedogenic

.Michael Fetterman
---------------


Many thanks to Dr. K. Smith for the Skin Cap handout. Today another
patientwith psoriasis who has been using Skin Cap for the past three
weeks said thather menstrual cycle had been affected. According to this
patient, her menstrualcycle is very regular, and the only other times it
has been affected was whenshe was using dermovate extensively. Boy, am
I getting worried about Skin CapSpray!

Melinda Tong, MRCP
---------------


While waiting for the dust to settle on what-is-skincap-anyway, I
recalled apearl from Bill Schorr. Bill always used Kenalog spray when
treating discoidlupus. His instructions were to spray a small amount in
one palm and use thefingers of the other hand to rub it into the lesions
four times a day. Havingseen failures (my own and others) with
conventional supra-potent cortisones thathave responded to Kenalog
spray, I have adopted this treatment, but not tried ityet for psoriasis. I've
always assumed that the vehicle was key.

John Melski MD
---------------


One of my patients obtained a can of skin cap from Madrid and the
listedingredients were Zn Piritionato 2mgm/ml and Metil etil Sulfato(de
Sodio) 1mgm/ml. I could translate most of the label and assume Caspa is
the name forSebborhea and Zinc Pyrithione was not difficult,however I
would appreciate aSpanish understanding colleague to tell me what Metil
etil Sulfato(de Sodia) isand its purpose.

Stephen Wiener
-------------


I called Dr. Lebwohl today (August 4,1997) and he confirms that
clobetasol wasfound in Skin Cap - albeit at a "lower concentration then
Temovate". He feelsthe other ingredients are playing a part in the results
obtained by many withthis product.Hopefully we'll hear more about this in
print!Can someone contact him by E-mail, and ask him to comment in this
forum?

Robert I. Rudolph, M.D., FACP
--------------------


Here is another way to explain the vehicle effectof Skin Cap spray.The
lipid elements of the stratum corneum melt temporarily and reform
quicklywith greater airtightness. This transient stratum corneum
meltdown allows theactive ingredients to penetrate into the epidermis in
the window of opportunitybefor the stratum corneum reseals. This
hypothesis accounts for the short-livedburning sensation which many
patients report which I interpret as a transientincrease in transepidermal
water loss.I wonder if this is only isopropyl myrsitate, or is it also in
part the spraypropellant.

Rhett Drugge, M.D.
-----------


In addition to isopropyl myristate (IPM) acting as a potential
penetrationenhancer to facilitate the percutaneous absorption of 'active
agent(s)' inSkin Cap as KC Smith wrote, sodium lauryl sulfate (SLS), if
present, can alsoact as a very potent penetration enhancer by disruption of
lipid bilayers anddenaturation of proteins comprising the stratum
corneum. IMHO combinations ofIPM & SLS can be very irritating to the
skin. R Drugge also raises the issueas to potential activity associated
with the propellent.The addition of clobetasol dipropionate to an IPM/SLS
vehicle may reducethe frequency and severity of irritation expressed.
Addition of clobetasoldipropionate to Skin Cap Spray may account for the
recent posts regardingrebound following termination of treatment (Drs.
Tong and Thaler).It would be of interest if Dr. Crutchfield could have
samples of Skin CapSpray used in his psoriatic clinical trials analyzed for
the presence ofclobetasol dipropionate.

Daniel Bucks
The contents of this message are theopinion of the sender and do not
necessarily reflect the opinion of Penederm Inc. or its management.
------------------------


Skin Cap just shows that if you administer enough corticosteroid
psoriasis andother inflammatory disorders will back off. Big deal. We
knew THAT 40 yearsago. If Skin Cap was a prescription drug and had
proper data to back it up I'dstill be very reluctant to recommend it,
because we have other better and safertreatments for psoriasis and other
inflammatory disorders. I doubt that it would ever get licensed, if for no
other reason than because an aerosolof clobetasol propionate could be
inhaled or get in the eyes (see below).What's needed today is an algorithm
we can use for the patients who will be inthe office TOMORROW, some of
whom may have used large amounts of clobetasolpropionate (who knows
what concentration?) for up to 18 months, in apenetration-enhancing,
rapidly evaporating vehicle system which includedisopropyl myristate.I
would not minimize the potential problems or be too reassuring.Here's my
first iteration. As always, your input is needed to refine thisthing:a.
explain and document the risks of long-term high dose clobetasol
propionate-- including in particular adrenal suppression, osteoporosis and
avascularnecrosis of bone (AVN). (The liability clock -- "discovery &
disclosure" --probably STARTS ticking as soon as you tell them this stuff,
then runs out in12-24 months, depending on your jurisdiction).b. get a 24
hour urine for cortisol to see if they are adrenal suppressed. If they
appear suppressed, they'd best see an endocrinologist for formal
determination of the degree of suppression and appropriate advice and
therapy ofthat issue.c. cover them with other therapy (eg. cyclosporine,
methotrexate, etretinate /acetretin, UV-B or PUVA, Dovonex, Taxorac) to
reduce the risk of rebound whenthe Skin Cap is stopped.d. there may be
considerable anger and reactive depression (possiblysuperimposed on
steroid-associated mental changes) when Skin Cap is withdrawn.Patients
should be monitored for this, and treated / counselled / referred
asappropriate. My guess is that out of this large a patient population
there willbe some suicides, and a number of other lesser problems (job
loss, marriagebreakdown). With good pro-active psych care we should be
able to minimize theincidence of these problems in the subset of patients
we care for.e. Depending on duration of use and amount used bone
densitometry to assessosteoporosis could be appropriate. Unfortunately
most corticosteroid-associatedbone loss happens in the first 6 months of
therapy, so there may not be a lotthat can be done with calcium / vitamin
D / alendronate or other bisphosphonatesat this point in time. The
endocrinologist can maybe help in this area.f. If there is joint pain, in
particular affecting the head of the humerus orthe femur, rapid referral
for assessment and treatment of avascular necrosis(AVN) of bone will be
important. MRI of suspecious joints about the mostsensitive and specific
test that is readily available, and if there is evidenceof AVN ***rapid***
referral for core decompression of the affected joint canreduce long-term
disability and reduce the risk that joint replacement surgerywill be
needed.Patients should be counselled that the symptoms of AVN can come
on months oreven years after corticosteroids have been stopped, and if
they notice symptomssuggestive of AVN (eg. sudden onset of pain,
difficulty weight bearing, reducerange-of-motion) they should seek
immediate medical advice and rapid treatment)- from you or from an
orthopod, not just from some random doc who may not befamiliar with
AVN. They should be told that the risk of AVN may be reduced byavoiding
obesity, smoking and alcohol consumption, and current status withregard
to those risk factors ought to be documented.g. If a lot of Skin Cap spray
has been used, in particular on the chest, faceor scalp, it might be worth
having an ophthalmologist rule out glaucoma and / orcataracts; and you
might want to cover the patients for steroid-induced acnerosacea (eg.
Minocin 100 mg hs or bid, and Metrogel or Sulfacet-R lotion bid).h. The
rip-artists will be out in force trying to capitalize on the demise ofSkin
Cap. A flat warning to patients about quack remedies could be helpful.The
NIH puts out a brochure about Quack Remedies, which I have found
quitehelpful in my attempts to "immunize" my patients who have chronic
conditionslike psoriasis against the quacks who are endlessly trying to
prey on them.It is useful with people who have had psoriasis for a long
time to say: "Manyof my patients with psoriasis who have had psoriasis
for a long time have seen alot of quack remedies and ripoffs come and go
over the years. What has yourexperience been?" This usually puts things
in perspective, as they list for meall the time and money wasting
over-the-counter, "health-food-store" and"natural" remedies they have
tried. Currently most bitching is about Exorex --very expensive, not very
useful, manipulative 1-800 "support line", etc.......

Kevin C. Smith MD FRCPC
-------------


I would not minimize the potential problems or be too reassuring. >>
Kevin, Asusual your comments are complete, scientifically valid, and well
reasoned, butthe idea that patients who have used SkinCap have absorbed
enough Clobetasol tocause all the side effects you mention is a big leap
from the discovery of alittle clobetasol in a few cans. Patients on
systemic steroids USUALLYexperience clinically apparent Cushingoid
features before they experienceosteoporosis, avascular necrosis, and
severe adrenal suppression. If there aredozens of patients out there at
risk for these dire complications, then thereshould be hundreds of
patients with Cushingoid facies, buffalo humps, andobesity, and I've not
heard of a single such case.While it may be appropriate for physicians to
keep all your warnings in theirheads, I would hate to see all the patients
who have used Skin Cap subjected toan Alar-like scare campaign.Obviously
the FDA had to remove this product from the market because of
itsdisreputable origins. However, unlike you, I still harbor the strong
suspicionthat we are seeing more than just a steroid effect with this
product, and thatsomething similar could pass muster as a reasonably safe
prescription remedy forpsoriasis.

Mark Valentine
-------------


Thanks for posting the entire article: a huge help to SkinCap users like
me.BTW, I'm struck and pretty unhappy over the hysterical tone the NPF
appears tohave taken. One, just because there's clobetasol in there doesn't
mean that'sthe active: anyone who's used this stuff knows it is infinitely
more effectivethan any Temovate formulation. Two, to overemphasize the
risks of topicalclobetasol the way this press release does (makes it sound
worse than cisplatinum) is unnecessary.

Mark Ling, M.D., Ph.D.
---------------


This morning's local papar had a wire service blurb on Skin Cap spray,
sayingthat the FDA was warning nationwide about it containing powerful
steroids, andfor all patients to consult their physician regarding safely
tapering off ofthem. The FDA is also having customs stop any new
shipments from Spain. It isinteresting that they used "This unapproved
product" as a desription in thearticle, since many of us were led to believe
that the FDA allowed this to beclassified as OTC. The other question is:
can Skin Cap still be dispensed byphysicians as a presription product (ie
clobetasol spray), since we deal withclobetasol on a regular basis.
Hopefully there will be some attempt to get itapproved (?Glaxo), but will
the FDA be so angry that they will not approveit. I assume that web pages
will sprout up outside the US, with psoriasispatients ordering Skin Cap
offshore and having it mailed to them, to useunmonitored. An interesting
situation.

Mike Crowe, M.D.
-------------


It is interesting that they used "This unapproved product" as a desription
in the article, since many of us were led to believe that the FDA allowed
this to be classified as OTC.It was OTC under the monograph for seb derm,
not psoriasis. So it was"unapproved" for this usage.>> The other question
is: can Skin Cap still be dispensed by physicians as a presription product
(ie clobetasol spray), since we deal with clobetasol on a regular basis.I
doubt it. It will have to be tested to show that the ZPT doesn't add risk
anddoes add benefit, just like any other combination drug eg benzamycin.
Any drugcompany that tests it will run the risk that its results will be
used to supportthe OTC usage for psoriasis and will have wasted its $$.
As a combination withanother Rx drug is a possibility though.

Guy Webster
------------


The email is starting to flow in from patients who've found my Skin Cap
"lack ofinfo" sheet on the net.This is my reply to one such question:To:
ksmithderm@aol.comI was just made aware of the FDA warning regarding
Skin Cap today. I have beenusing this product for approximately a year and
a half. As a result of thatwarning, my husband and I began searching the
internet for information. I cameacross your e-mail message dated 7/2/97
regarding this product. While Skin Caphas all but "cured" my psorasis, I
have recently noticed that I bruise easilyand have experienced unexplained
joint pain. As most people do, I associatedthis with other things, i.e.
growing older, etc. (I am a 36 year old female).I am very concerned over
yesterday's FDA ruling, and do not know who to contact.Should I see a
dermatolgist, internal medicine dr., etc? Any comments orinformation
you can provide will be greatly appreciated. Debbie Reply:Depending on
how much Skin Cap (highly absorbed praparation of clobetasolpropionate -
an ultrapotent corticosteroid) you've been using, you could belooking at big
trouble. There are a lot of things that can go wrong, but inparticular get
your doctors to look for ADRENAL SUPPRESSION, OSTEOPOROSIS,
and(worst) AVASCULAR NECROSIS OF BONE (notably in the shoulder and
hip). All ofthese very serious problems have already been described in
patients who wereusing large amounts of clobetasol propionate on the
skin.You'd best see a dermatologist and perhaps also an internist.Maybe
print this for your doctors, together with my Skin Cap "Lack
ofInformation" Sheet.

Kevin C. Smith MD
----------


In this group some have reported that Skin Cap has helped patients who
hadsevere psoriasis refractory to other treatments. Certainly this will
make somefeel the need to support the availability of the product.This
should be weighed against the argument that we shouldn't
supportunscrupulous manufacturers who would make available through
OTC channels aproduct which contains a potent topical corticosteroid.
How many of us thinktriamcinolone should be available OTC?
Fluocinonide? Clobetasol proprionate?!Can we possibly support a company
that would make clobetasol proprionateavailable in a manner not subject
to physician supervision, worse still, tellingpatients (and their
physicians) that use of the product avoids the need fortopical steroids and
their inherent risks? And if the product does deliver theclobetasol
proprionate in such a way as to have greater efficacy than
Temovate,surely the risks of side effects are even higher. And would you
trust such acompany not to put other toxic agents in the product, to
produce the product ina safe manner, or to have any degree of quality
control whatsoever?I don't see this as a plot by "strong steroid"
companies. In the U.S. we havea system that has allowed us great
confidence in the products we prescribe orrecommend to patients. The
breakdown of this system would adversely affect ourability to care for all
our patients. While I can see that if my patients withsevere disease were
benefitting from this product it would hurt them to loseaccess to the
product, it is probably much worse to let this kind of abusecontinue. If
dermatology were to support this kind of abuse, what otherdeceitful,
dangerous products might we see next.

Steve Feldman, MD
-----------


TYPE OF ALERT : Detention Without Physical Examination(Note: This
import alert represents the Agency's current guidance to FDA
fieldpersonnel regarding the manufacturer(s) and/or product(s) at issue.
It does notcreate or confer any rights for or on any person, and does not
operate to bind FDA or the public.)
PRODUCT : Skin-Cap Spray, Shampoo and Cream
PRODUCT CODE : Spray: 61SAQ99, 61SAQ01, 61HBQ05, 62SAQ01, 53J02
Shampoo: 61HBL05, 62SAL01, 53E06 Cream: 62SAJ01, 53L03
PROBLEM : Product is an OTC product containing a prescription
strength corticosteroid (clobetasol propionate).
PAC FOR COLLECTION : 61D800
COUNTRY : Denmark (DK, 315) Spain (ES, 830)MANUFACTURER/ SHIPPER
: Manufacturer: Laboratorios Cheminova Laboratorios Cheminova
International Laboratorios Internacional, S.A. Madrid, Spain
FEI#3000384282
Shipper: Cheminova Holding A/S P.O. Box 9 DK-7620 Lemvig, Denmark
FEI# 647 FEI# 1000195766 FEI# 1000645258
CHARGE : This article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to be a new drug within the
meaning of Section 201(p) without an effective new drug
application (NDA)[Unapproved New Drug, Section 505(a).]
RECOMMENDING OFFICE : CDER, Office of Compliance, Division of Labeling
andNon-Prescription Drug Compliance, HFD-310
REASON FOR ALERT : Skin-Cap, an over-the-counter (OTC) drug for
psoriasis wasfound by FDA analysis to contain prescription levels of a
potent medication, thetopical steroid, clobetasol propionate, which can
cause serious side effects ifused incorrectly or unknowingly. Users would
be unaware of the presence of thisingredient, as it is not declared on the
labeling for the products. Side effects from long-term use of potent
topical steroids can include stretch marks,thinning skin, and tiny dilated
blood vessels. Use of large amounts, overuse orlong-term use of potent
topical steroids can also cause more serious sideeffects.
Skin-Cap is an over-the counter (OTC) drug sold in various forms (spray,
cream,shampoo) that is manufactured by Cheminova International
Laboratories, Madrid,Spain, and is available through several U.S.
distributors.Psoriasis is a chronic skin disorder that can be painful and
disabling. It is characterized by inflamed, red, scaly lesions, caused when
affected skin cellsreproduce six times faster than normal skin
cells.According to Cheminova International, the active ingredient in
Skin-Cap is zincpyrithione (ZnP). ZnP is the same active ingredient found
in some dandruffshampoos, for which there is no history as an effective
psoriasis treatment.Zinc pyrithione (ZnP) has never been found safe and
effective for the treatmentof psoriasis. ZnP is acceptable as an OTC
product for the treatment ofseborrheic dermatitis and dandruff only.
GUIDANCE : Districts may detain, without physical examination all
shipments of Skin-Cap Spray, Shampoo and Cream.For questions or issues
concerning science, science policy, sample collection,analysis,
preparation, or analytical methodology, contact the Division of
FieldScience at (301) 443-3320 or 3007.If private laboratory analysis
DOES NOT INDICATE the presence of clobetasolproprionate, please contact
Robert Eshelman of CDER's Division of Labeling andNon- Prescription
Compliance at (301) 594-1065.
PRIORITIZATION GUIDANCE : IFOI : No purging is required.KEYWORDS :
Cheminova, dandruff, psoriasis, seborrheic dermatitis,
unapproved prescription drug, corticosteroid,
OTCPREPARED BY : Deborah Browning/Fredda Shere-Valenti, HFC-172,
(301) 443-6553
DATE LOADED INTO FIARS : August 8, 1997
OTC psoriasis drug potentially harmful, warns National Psoriasis
FoundationSkin-Cap, a popular over-the-counter (OTC) drug used for
psoriasis, may containan undisclosed superpotent prescription medication
which can cause serious sideeffects if used unknowingly. The National
Psoriasis Foundation (NPF) is urginganyone using this product to consult
with their dermatologist.FDA analysis has shown this product contains
prescription levels of asuperpotent topical steroid, clobetasol propionate,
and the agency is warningpeople about the product. Mass spectrometric
analyses of Skin-Cap performed by investigators at the Mayo Clinic in
Rochester, Minnesota, also suggest thepresence of clobetasol propionate.
In addition, tests performed by labs atGlaxo Dermatology, a division of
pharmaceutical company Glaxo Wellcome Inc.,found clobetasol propionate
in Skin-Cap, and Glaxo confirmed those findings withan outside
independent laboratory.Anyone using Skin-Cap should immediately discuss
these findings with theirdermatologist. When used as prescribed by a
physician, clobetasol propionatecan be a safe and highly effective
treatment for psoriasis. However, sideeffects from long-term use of
potent topical steroids can include stretch marks,thinning skin, and tiny
dilated blood vessels. High doses, overuse or long-termuse of potent
topical steroids can cause very serious internal side effects.Note: If you
have psoriasis, you should not stop using any product containingtopical
steroids without the guidance of a dermatologist, because
abruptwithdrawal from topical steroids can significantly worsen
psoriasis, and causethe disease to flare.Skin-Cap is manufactured by
Cheminova International in Madrid, Spain. It hasbeen available in the US
through several distributors. Cheminova Internationalclaims that the
active ingredient in Skin-Cap is zinc pyrithione (ZnP). ZnP isan active
ingredient found in some dandruff shampoos, which have no history
aseffective psoriasis treatments. Cheminova has repeatedly denied the
presence ofcorticosteroids in Skin-Cap, most recently in a letter to the
NPF dated August4.ZnP has never been found to be safe or effective for the
treatment of psoriasis.As an OTC product, Skin-Cap has never been
approved by the FDA. ZnP is approvedas an OTC active ingredient for
seborrheic dermatitis and dandruff only.Previous reports from several
European countries that Skin-Cap contained topicalsteroids led the NPF to
ask investigators to perform tests in the US. The DutchHealth Ministry
ordered Skin-Cap banned from sale in late May because theproduct
contained unreported steroids. Psoriasis is a noncontagious, chronicskin
disorder that can be painful and disabling. Over six million individualsin
the US are affected by psoriasis. Uncontrolled, psoriasis can limit
aperson's ability to walk, bend, grasp, or sit. In rare instances, people
candie from complications of psoriasis.Psoriasis is characterized by
inflamed, red, scaly lesions caused when affectedskin cells reproduce six
times faster than normal skin cells. Approximately 10%of people with
psoriasis also develop a form of arthritis (psoriatic arthritis).There is
currently no known cure for psoriasis, which is believed to be
anautoimmune disease like rheumatoid arthritis.The NPF is a lay,
nonprofit health organization with a mission to provideinformation and
support to people with psoriasis. Through public education, theNPF hopes
to stimulate research to find a cure for the men, women, and childrenwho
suffer from this disease.For more information on all treatments for
psoriasis, call NPF at1.800.723.9166.

----------------


Three scenarios:
1. For patients who have used a small amount for shortperiods: Stop
using the product. See your physician for other treatmentoptions. Risks
of stopping are unlikely.
2. For patients using large amounts for short periods (less than 2 weeks):
Stop the product. See your physician for other treatment options. If you
experience signs of adrenal insufficiency (nausea or vomiting, abdominal
pain, muscle weakness or fatigue), contact your physician. If you are in an
accident or require surgery, let your physician know in case supplemental
stress doses of corticosteroids are indicated.
3. If you have been using large amounts for prolonged periods: Stop
the product under the guidance of your physician. See your
dermatologist for other treatment of your psoriasis (as the disease may
flare when stopping the medication). See your internist for consideration
of testing for adrenal suppression and/or long-term corticosteroid taper
to prevent acute adrenal insufficiency. If you have any unusual
symptoms of hip or shoulder joint pain, see an orthopedist for evaluation
of avascular necrosis. If you experience signs of adrenal insufficiency
(nausea or vomiting, abdominal pain, muscle weakness or fatigue), contact
your physician. If you are in an accident or require surgery, let your
physician know in case supplemental stress doses of corticosteroids are
indicated.Does that sound reasonable?

Steve Feldman, MD
-------------


I really like your practical stepwise approach to the problem of getting
peopleoff Skin Cap.I'd add that where Skin Cap was used on the face or
forehead for more than a fewweeks an eye exam to rule out glaucoma
and/or cataracts might be useful.If a lot (eg. 1 can per week?) of Skin
Cap has been applied for more than acouple of months, I'd get a bone
densitometry to assess for osteoporosis, andthen if necessary send them
to someone who knows about that problem for adviceand therapy.Does
anyone know the concentration of clobetasol in Skin Cap? eg. if it
is0.05%, then 200 grams of Skin Cap = probably MORE than 200 grams of
Temovate /Dermovate, because absorbtion of clobetasol from the
penetration-enhancerdelivery system of Skin Cap is probably higher than
from cream or ointment.If Skin Cap is 0.1% clobetasol propionate, then
200 grams of Skin Cap probably =more than 400 grams of Temovate /
Dermovate. And so on up the scale, dependingon what the clobetasol
concentration turns out to be. In a worst case scenario,where the dose in
a can of Skin Cap was equivalent to say 400 grams of Temovate/
Dermovate per week, a wide range of serious problems could be
anticipated withhigh frequency, starting after a month or two.People with
experience with Skin Cap please: what is the typical range ofamounts and
durations of use of Skin Cap? What proportion of patients arelikely to
have used more than half a can a week for more than a month or two?You
see why I am kind of spooked by the potential risks.

Kevin C. Smith MD
-----------


I've always warned pts about risks of the unknown with SkinCap. I'm just
alittle concerned that the current response, which I find a bit
overwrought, willend up losing a real opportunity to help explore psoriasis
therapy. I useTemovate a ton, and with a little discretion don't feel it
poses a significantrisk to my pts. I understand the regulatory issues well,
but wish the psoriasiscommunity in dermatology was willing to debate
this further (as we are doinghere) before issuing a final stance, a la NPF.

Mark Ling, M.D., Ph.D.
-----------


Nope, as a heavy SkinCap user I beg to disagree, Steve. One of many
anecdotes:female pt with worst scalp psoriasis I've ever seen. Absolutely
no response to,among other things, MTX, cyclosporine, Accutane, PUVA
(she was compliant enoughto shave her entire scalp and wear a wig for
months!), RePUVA usingisotretinoin, gallons of topical Temovate lotion
faithfully applied, Dovonex,anthralin, oral antibiotics, long course of
suppressive Diflucan, and a fewother things I cant remember. Huge,
hyperkeratotic plaques, often staphsuperinfected to the point of focal
scarring alopecia. Repeatedly biopsied andconfirmed as psoriasis. Bottom
line: she's CLEAR on NOTHING but SkinCap now.Compared to what she's
been on before, SkinCap is like water from a safetystandpoint. She would
be crazy to stop using it. I've got plenty of otherstories which I feel
strongly argue that this stuff isn't just compliantTemovate.

Mark Ling, M.D., Ph.D.
-------------


Mark, I'm sure you're right, both about this and about the need for
moderationwith respect to warning patients. However, I don't thing the
zinc is the activeingredient in Skin Cap; otherwise, this horrendoma story
you describe would havecleared with Head and Shoulders. Up to now, the
only thing that makes any senseis the clobetasol. Now perhaps your
patient absorbed enough to have a systemiceffect with a response (and
presumably potential for side effects) akin to whatwould have happened if
you put her on oral prednisone in high enough doses. Ithink the patient you
described is the best reason yet to be very worried aboutthe systemic
corticosteroid side effects of Skin Cap.

Steve Feldman
---------


The first two patients I saw this morning were herded in here by thescare
stories on the evening news. One I had treated for psoriasis with
chronicintertrigo. He brought in an empty tube of Nizoral and said since it
didn'twork he used Skin Cap from the health food store. He has been using
itintermittently in the groin for a year+.Now I ask, have any of you seen a
potentsteroid used in the groin for a year NOT produce striae? I have seen
striaefrom Lotrisone repeatedly, even after one month usage.If this stuff
isclobetasol, why don't wee see the usual steroid side effects?

Haines Ely
-------------


Let me clarify before I give a very incorrect impression. I think that Skin
Capis "like water" regarding toxicity COMPARED TO WHAT SHE'S BEEN ON
BEFORE(cyclosporine, MTX, etc). I'm still not convinced that this effect is
systemicsteroids. She is able to keep her scalp in control with a once a
day 1/2 secondspray to about 1/3 of her scalp. A bottle is about a two to
three month supply.Roughly this means she's using perhaps 0.5 to 1.0 cc of
spray a day. At aputative concentration of 0.1%, she is getting up to 1 mg.
of clobetasol a day.Given that a substantial portion is sprayed onto hair,
her husband, the mirroretc., and presuming that total absorption of the
clobetasol that actually getsonto the skin is less than 100%, the total
steroid she's absorbing is rathersmall I suspect. I'll check a number of my
pts for evidence of adrenalsuppression in the coming weeks/months, and
if I'm wrong and it is happening youall will be informed immediately.
Very interesting if annoying situation: asalways I am indebted to the list
for keeping me current.

Mark Ling, M.D., Ph.D.
------------


Before we all (including the FDA I might add) conclude from one report
byapparently one observer that skin cap = clobetasol, why not do
somethingscientific like sample a dozen or so different lots to see if this
is real ornot. My understanding is that it has been assayed for steroid
before and nonehave been found. Now that we have a single positive report
we are supposed tobelieve that over all of the negative ones? Even if the
stuff is clobetasol itseems to work better than any topical steroid I have
ever seen, and I hope thatthe makers of clobetasol come out with a similar
approved product, becausewhatever Skin Cap turns out to be, I still
consider it a major advance intopical therapy and probably the most
potent topical ever for psoriasis. Thatmuch seems true, regardless of the
ethical or unethical behavior of themanufacturer. Our patients will be the
losers if the drug is withdrawn from themarket permanently.

Mark Naylor, M.D.
----------


For sure. I thyink the story, from Holland to here, is that steroids
haveintermittently been in SkinCap (in Holland I think they reported
triamcinolone,here clobetasol), but that is sort of besides the therapeutic
point ( though notthe ethical or legal ones).I'll join the speculative fray
and repeat that I suspect skin cap contains apotent, unidentified
antimetabolite (as opposed to antiinflammatory) agent.

Michael Fetterman
-----------


Having had a night to sleep on this, let me amend some of my comments:I
do agree fully with Steve Feldman that the unethical behavior of the
companyis highly unethical, and dangerous, and I agree fully with taking it
off themarket while this is clarified. I also agree that patients on Skin
Cap need tohave information made available on what the implications of
these findings are,and at least until the steroid issue is worked out, need
to be weaned off.There's no way in the world I want clobetasol available
OTC!Still, I am in the "something besides steroid" camp on this stuff.
Based onCharles Crutchfield's experience, I suspect I'll see how DermaZinc
works in myhand. I'll also follow up with any potentially steroid related
side effects asI see my patients again.

Mark Ling, M.D., Ph.D.
--------------


i have a very compliant japanese patient who used temovate bid to his
rightforearm for 4 weeks with about 15% improvement and skin cap to his
left forearmfor 2 weeks...and the skin cap side was perfectly clear...and i
have a severeatope responding only a bit to oral corticosteroids (from
another md), not atall to temovate...and is clear on skin cap... steve
EmmetCLOBETASOL has been found in Skin Cap by, among others, Mayo
Medical Labs(state-of-the-art) and Glaxo (state-of-the-art), the Dutch
government and a labin Canada.What we need to know is the concentration,
because this will help with riskasessment and drug withdrawl.The US
government ought to ask the Spanish government to lean on the Skin
Capweasles and get proper answers, if qantitative testing here is not
producingadequate answers.

Kevin C. Smith MD FRCPC
--------


Posted on alt.support.psoriasis"Subject: The truth about skin-cap

From: vilana@earthlink.net Date: Mon, 11Aug 1997 20:27:04 -0700
Message-ID: <33EFD808.3334@earthlink.net>
<HTML>The rumors you have heard on the media about the FDA and the
NationalPsoriasis Foundation mentioning harmful effects using Skin-Cap
are not true.We can assure you
FROM THE CHIEF OFFICE OF CHEMINOVA LABORATORIES
(http://home.earthlink.net/~vilana/chemdoc.jpg )- THERE ARE NO
STEROIDS IN SKIN-CAP.The rumors started with an article published in the
National PsoriasisFoundation Newspaper, about a test study published in
the Netherlands, whichstated that there were steroids in Skin-Cap's
formula, which caused a temporaryI interruption of sales in that country .
According to the National PsoriasisFoundation the product seems to be
very effective, their concern is that theycouldn't find any published test
studies in the United States.Cheminova Laboratories, has taken all legal
measures in this matter and wassuccessful in proving that the test was in
error. According to the GeneralManager of Cheminova Mr. Aly Santa
MArta, The Dutch Authorities allowedimmediate return of Skin-Cap to the
Dutch market. Our competition is afraid ofthe success of our product and
is trying to exploit this fact to their favor.Cheminova Laboratories is
conducting right now, in conjunction with the F.D.A.,the development of
American studies to prove the safety and effectiveness of ourproduct and
the absence of any steroids in the formula. There are more than100,000
Skin-Cap users in the United States and millions in over 35
countriesworld wide using the product fir the past 9 years without any
reproted sideeffects. Skin-Cap is the most successful treatment in the
world for severe skindisorders.For more information on the subject,
please feel free to contact us with morequestions at 800 321-SKIN (800
321-7546). If you want, give us your Fax numberand we will send you
more detailed information.The VILANA Company

---------------


For the slightly-paranoid among us, note that today's AAD FAX about skin
capspray said that the initial studies finding steroids in Skin Cap Spray
were doneby Glaxo! I agree with Dr. Ling that this is a remarkable product
and needs furtherstudy.

Philip Hughes, M.D.
------------


Samples of Skin Cap purchased in several Canadian cities were
(surprise!surprise!) all found to contain clobetasol propionate and the
Health ProtectionBranch of our federal government banned Skin Cap
Wednesday 13 August.The Canadian Skin Cap weasels (eg. Andrew
Two-Names, et al.) tried to pre-emptthe feds by "voluntarily withdrawing
Skin Cap" but they still got slapped with a"cease and desist order", and the
feds issued the by-now standard press releaseabout the dangers of
clobetasol propionate, in particular if used in largequantities (eg. more
than half a can of Skin Cap per week) and for longer thana couple of
months.

Kevin C. Smith MD FRCPC
------------


I heard Dr. Koo speak last night on Tazorac but he gave what sounded
likewell-informed commentary on Skin Cap. He said there were four
independent labsthat found clobetasol (I don't remember Glaxo). He said
the zinc concentrationswere all over the map (0.2% to greater than the 2%
listed) and that is part ofwhat got FDA and others even more suspicious if
that was the main "active"ingredient. Like others, I'm still interested in
the truth of this matter,since there is no doubt that the product worked
better than anything else in our"formulary" for psoriasis (especially
scalp).

Eliot Mostow, MD
-------------


2% zinc anything is a strong fixative! Furthermore it is highly corrosive
andwill bubble and strip paint.

Terry L Marshall
------------


have seen about 5 skin cap users so far this week. all have universally
beenhighly upset about losing this treatment, and not very concerned re
toxicity (toa person, they all have used lots of Temovate in the past and
were surprised atthe dangers listed).

Mark Ling, M.D., Ph.D.
--------------


The Dutch DID find clobetasol according to a private email I got from
someone atthe NPF. Betamethasone was also found in one jurisdiction, but
I can't recallif that was the Netherlands. I kind of think it was Austria

.Kevin C. Smith MD FRCPC
-------------


Reading the steady stream of testimonials for Skin Cap on this list and
inalt.support.psoriasis my position remains unchanged. The fact that we
know ithas clobetasol does not make Skin Cap a whole lot safer to use.To
quote from my fatwah on Skin Cap, promulgated in July:Skin Cap can be
very effective in controlling a number of unrelated inflammatoryskin
conditions, including psoriasis, lupus and lichen planus. Unfortunately
there are many things which we will need to learn before Skin Cap can be
safely recommended.Skin Cap appears to be a VERY potent broad-spectrum
anti-inflammatory andperhaps immunosuppressive or immune-modulating
medication. Medications whichare very potent often also have a great
ability to cause serious problems undersome circumstances. Because Skin
Cap is not a prescription medicine we do not have the information from
the laboratory experiments, experiments with animals, or experiments
withhumans that are available for virtually all of the other medicines and
othertreatments that we use in dermatology. Because medical and
scientificinformation on the safety of Skin Cap is not available:
1. I do not know how Skin Cap works.
2. I cannot predict what kinds of problems you may develop after
long-term (months to years) or in some cases even short-term (days to
months) exposure toSkin Cap.
3. I do not know if there is a safe limit to the amount of Skin Cap you can
beapply every day.
4. I do not know if there is a safe limit to the number of days or weeks
SkinCap can be applied.
5. I do not know if there are some parts of your body where Skin Cap
should notbe applied.
6. I do not know if Skin Cap might make some diseases worse (for
example skininfections or skin cancer).
7. I do not know if there are some people (for example children,
pregnantwomen, or old people) who may be at increased risk for problems
if they areexposed to Skin Cap.
8. I do not know if there could be an increased risk of problems (for
example,skin cancer) if Skin Cap is used in combination with or following
othertreatment, such as ultraviolet light, methotrexate, cyclosporine
orcorticosteroid creams.
9. I do not know if inhaling traces of Skin Cap while it is being sprayed,
orabsorbing it though the skin, could cause internal problems. For
example, it ispossible that the potent anti-inflammatory and possibly
immunosuppressive effectof inhaled Skin Cap could increase the risk of
yeast infections in the mouth andairway, and perhaps also increase the
risk of dangerous lung infections likePneumocystis carinii. The animal
and human experiments which are necessary todeal with these issues (and
which would have been required if Skin Cap was aprescription medication)
have not been done.Because the risks of Skin Cap are unknown, it is not
possible to accuratelyweigh the risks against the benefits.You should not
use Skin Cap unless you are willing to accept the possible risksand side
effects (including risks and side effects we are not aware of yet.)

Kevin C. Smith MD FRCPC
--------------


In many ways what you're saying is exactly what I say, but with a
differentslant. Imagine a world without lawyers, or fear of malpractice--
a world wherepersonal responsibility for one's own actions is taken for
granted. This wouldbe a world where it was recognized that society can't
be help responsible fordecisions an individual makes, good or bad. In such
a utopian setting, I wouldargue that the decision to use skin cap would
ultimately be the patient's, andthat our job as physicians would be to
advise capably. The notion that apatient could use a product like Skin Cap,
recognizing full well that thephysician could in no way guarantee safety
for perpetuity, would be just fine inmy mind as long as they realized it
was their decision. Many of my patients areperfectly clear in their minds
that this stuff was potentially risky, butelected to make that decision to
use it because the toxicity of theiruncontrolled psoriasis was worse in
their minds. You or I might not choose touse it, but it's sad that our
screwed up societal standards of responsibilitymakes us unwilling to
offer patients opportunities. NOT to say that skin capshould stay on the
market--I believe they were crooked and unethical--but in amore general
sense, this is why I feel the FDA has been much too overprotectivein a
misguided attempt to protect us from any possible risk.

Mark Ling, M.D., Ph.D.
------------


If the isopropyl myristate in SKIN-CAP really enhances
transepidermalpenetration that much, why isn't it more widely used?

Steve A. McClain, MD
--------------


At the Canadian Derm last month Bill Danby reported seeing early striae
andpossibly hypertrichosis, I think after only a few months of use.

Kevin C. Smith MD FRCPC
---------------


I have recently treated a teenage girl with severe linear morphea of one
thighand leg with Lidex cream; she developed striae of the proximal thigh
in lessthan a month, in areas that she was not applying Lidex. I agree it is
puzzlingthat no striae are showing up 2ndary to Skin Cap, supposedly with
a muchstronger steroid. I admit teenagers and young adults seem to
develope striaeeasier, probably from growth spurts, rapid wt. gain,
exercise, etc.

Hal Rehbein
------------


I have actually called a sample of my psoriasis patients to whom I
recommended or monitored the use of Skin Cap. Several have stopped
because of expense.Most are using it with high success only a couple of
times a week, with better control than anything before. One patient has
told me she had a brisk inflamatory reaction to it and stopped. I believe
that any physician who has used this product open-mindedly cannot
helpbut be impressed with the results in an amazing proportion of
difficult patients. Regardless of the alleged transgressions of the
company I think itwould be a shame to throw out the baby with the
bathwater here. If the NPF really cares about its constituency, it should
be using all its clout to get FDA to do appropriate studies on this product,
as is, and find out how it can be used in a responsible and safe manner.
Some of the comments from this group have been examples, I think, of how
not to react in a situation like this. Instead of inflaming the issue with
visions of adrenal insufficiency and suicidal patients ( I have yet to see
atrophy or striae), we should be working toward better understanding of
this product. We should be taking action to protect the best interests of
our patients instead ofperhaps needlessly frightening them - and each
other. I think it is appropriateto keep our patients informed of what we
know about the situation as it unfolds, offer alternatives (such as Derma
Zinc, plus/minus a steroid) where necessary. For myself, I have contacted
a few patients by phone to see the general reaction. I plan to write a
letter and send it to those whom I have placed on it or know are using it.
The letter will outline the current situation as I understand it, outline the
small risk of side effects depending on dose, offerhelp to those who are
concerned they may be at risk for or experiencing sideeffects, and offer
help in finding alternatives until more is known.Other than having sold 50
cans of Skin Cap fom my office approximately at cost, I have no financial
interest in any product.

Jerry Eisner
---------


Sprayed skin cap on my arm, and applied Diprolene. Vasoconstriction
remains 5 hours after application of Diprolene, none where Skin Cap was
applied. And this is from a can which made miracles in one patient.

Diane Thaler
-----------


Received a fax from Cheminova Internacional,S.A. 8-14-97.It was a copy
of a fax forwarded to Mrs Tara Rolstad of the National Psoriasis
Foundation from Aly E. Santa Marta, General Manager(fax 213
3847155).This letter indicated that " tests showing no presence of any
Corticosteroids in our product Skin-Cap as proof of the analysis test of
molecular weight carrying out with Maldi-tof test..." "This analysis
confirm that the component of the Skin-Cap which was in doubt, has a
molecular weight of MW325 so far away from the range of steroids that
oscillate between 380 and 480," "We confirm that Holland authorities have
allowed the return to the Dutch market of the Skin-Cap immediately."
Two pages follow which detail the Maldi-TOF test.... Whatever the
outcome of all this, it IS interesting stuff and hopefully some group ?FDA
?NPF will help define this therapeutic agent so that our pts can have an
additional option

.Pierre Jaffe, MD
---------------


My position is simply that we should apply the same principles to Skin Cap
- and ask the same questions - as we do with any other therapy -
principles we learned in introductory pharmacology. These generally are
the questions I ask drug reps about new meds when they come to my
office. These protect my patients and ME. (I haven't done it, but I have a
piece of software on the Mac that records sound: 1 hour takes 14 MB, and
you can annotate as you go along. Handy for meetings -- could be great
documentation of what was said by a drug rep during a drug launch).These
are the questions I would have asked if a Skin Cap rep had come to see me:
1. Powerful drugs usually have the ability to cause harm. What is the side
effect profile of Skin Cap? How do I detect and deal with these side
effects?
2. What is the mechanism of action? I am going to run a literature search
-will you get me copies of the relevant papers from the scientific
literature if I give you the references? (This line has blown out a couple
of hucksters (eg.glycolic acid salesmen): " .... well, there's nothing
published yet ...."Reply: so, come back when you have data. Goodbye. End
of interview.)
3.. Is there a maximum safe dose?
4. Is there a maximum safe duration of use?
5. What is in this apart from the active ingredient? (eg. it was helpful to
know that some of the older forms of cyclosporine had ethanol in them
--patients on Antabuse needed to avoid that).
6. Are there some parts of the body where this should not be used?
7. Are there some people who should not use this? *Kids (yeah, I know
nothing is ever tested on kids, but are there any data suggesting that kids
should avoid your stuff?) * Pregnant women (as above) * old people (as
above) * people withcancer, herpes, fungi etc?
8. Are there some treatments that should not be used before, with or
after thistreatment? (eg. PUVA)Pity the poor unprepared drug rep who
hits me with a manager in tow, trying to launch a new product. On the
other hand, someone who is prepared to answer these reasonable questions
will look great. I wonder how the Skin Cap rep would have done?

Kevin C. Smith MD FRCPC
----------------

* Information was taken from www.psoriasis.org

 

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