Skincap Public Opinion

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.
------------------

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

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 T