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.For more information on Skin-Cap, call toll free: 1-888-6-Skin-Cap. Charles E. Crutchfield III, M.D. ----------------- I am very interested in this product as well, and have been happilysurprised to see that it seems to work, when similar zinc prythioneproducts, such as Head and Shoulders shampoo does not seem to have thiseffect. You mentioned chromatographic studies. Is the company willing to allow youaccess to records that might disclose anything else about the ingredientsin this product? Why should this product have an effect that other similarproducts do not?I remain skeptical and am a bit concerned about your enthusiasm. It isimportant to maintain a dispassionate approach to the testing of anyproduct, especially if the funding is from the company that makes it. I must admit that your inclusion of a telephone number in your note soundsa bit like an advertisement.As regards the comparison to Dovonex, it is my experience that a 100gm tubeof Dovonex goes a lot longer way than a can of Skin-Cap. Perhaps spray andointment applications cannot directly be compared. Additonally, incomparison to other products containing similar substances, Skin-Cap seemsgreatly over-priced.Having said this, I look forward to any well done study that might give memore information about whether this product has true therapeutic value. Jerry Eisner ---------------- My results parallel yours, and I am excited that you are working onobjectifying these anecdotal responses. I agree Skin-Cap appears tooutperform Temovate and Dovonex. Mark Valentine --------------- << The listed ingredients are:([activated]zinc pyrithione, sodium lauryl sulphate, isopropyl myristate, and propel 45 (propellant)).>What are the concentrations and what is the difference between "activated"zinc pyrithione and non-activated? Is activated zinc pyrithione availableto pharmacists for compounding? Walter H. Wood, M.D. ------------------- I called the toll free number given here for "Skin-Cap" (888 6 SKIN CAP) and got an answering machine message that said it was for "dermatitis". I left a message, first as a dermatologist, that I'd like to get some. There was no response in 2 days time. I called again as a layperson, again with no response in 2 days. I then got the local number and address in Miami from the information operator for Cheminova America. The first time I called I got an answering machine message that did noyt identify who or whom I was calling, but said that I should leave a message and they would call back, which that have yet to do. The local, Miami, number for Cheminova is 305 825 7008; the local address is 6073 NW 167th Street, Miami FL 33015. I may try to visit if I get an extra half hour to waste. Michael Fetterman ---------------- The toll free number that I have been giving to patients is 888-469-7546. They seem to be getting a good response at this number. I have now suggested this for 4 patients, including a physician. All have had dramatic responses. I'll be happy when I see a controlled study. It sounds too good to be all placebo/ moisturizing effect... I hope it doesn't turn out to be just the latest "fish oil." Mark Crowe, MD ----------------- Has anyone had any positive results with Skin Cap spray? I recall someearlier discussions on the list a few weeks ago regarding this. I had apsoriasis patient recently who has tried PUVA, MTX, Dovonex, topicalsteroids, etc. who elected to go to Memphis to Dr. Rosenberg for hisantimicrobial treatment (antibiotics + Nizoral + Nystatin). This patientwas only minimally improved on the regimen, and flared when he tried todecrease his methotrexate dose. When I spoke with Dr. Rosenberg about this,he mentioned that he was seeing good results with Skin Cap spray - in factenough that his psoriasis clinic had been cut in half due to the success ofthis OTC product. I have started a few patients on it but have not yet seenthem back. It has to be ordered through the mail from an 800#. Has anyoneelse had success or failure with this product? Mike Crowe, M.D. ---------------- I have been selling Skin Cap Spray in my office for about two months. Eithermy patients are conspiring to delude me or this is the most effective topicalproduct for psoriasis that is available in the USA at this time. Once theyfind out how effective it is, patients never again complain that theirinsurance won't pay for it. I see patients regularly who had disappointingresults with PUVA, Tegison, and any topical you can name, who are clearingdramatically with Skin Cap alone. It is orders of magnitude quicker thanphototherapy, and I really think it ranks second only behind methotrexate andcyclosporine in effectiveness. I am usually a skeptical therapist, andhave never in 20 years felt this degree of enthusiasm for any new therapy,excepting when Accutane became available for acne......Try it if you don'tbelieve me. I have no financial interest in this product, except as adispensing physician. In fact, I anticipate losing a fair amount of incomefrom patients who will no longer need phototherapy. We sold a can one Fridayafternoon to a 25 year old, a 15 year veteran of psoriasis therapy. She waswaiting on our doorstep Monday morning bouncing with excitement and eager toshow us how the Skin Cap was already working better than everything she hadever tried after just 60 hours. You can order the stuff wholesale fromInterstate Drug Exchange and save your patients the hassle of getting it bymail, and you can save them a few bucks in the process. Mark Valentine ---------------- I've been reading the messages about this stuff for quite some time, both with amusement and bemusement.I just had a patient come back from Mexico, and his widespread psoriasis is spectacularly better now that he's using Skin Cap. He's certainly better then the anthralin, Dovonex, and topical steroids I've prescribed ever got him! He's convinced it's this product, and not the anthralin and Mexican sun, that made him so much better. We'll see. Robert I. Rudolph, M.D., FACP ------------------- I'd be interested to know the serum zinc levels of people treated with SkinCap - if there is enough inhaled or taken up through the skin the serum zinccould perhaps reach toxic levels. Kevin C. Smith MD FRCPC ------------------------- Hope I am not totally wrong, but the thing is called Capsoft here. It is produced by a rather small company in Hamburg. About one year ago, they had a big scene in a quite popular TV talk show. There, the Capsoft fans (and the company for sure) complained that no medical center was ready to perform clinical trials without getting paid for that. On the other hand, on my request they just sent one specimen, so I couldn't make experiences with this magic product. And who would recommend the patients to buy a rather expensive spray instead of prescribing a conventional drug for free?Hans J. KammlerJena, Germany, LazyEuropeI have their address and phone no. at the office and will post it tomorrow if no one else posts it sooner. The latest study I read was in The Townsend Letter, an alternative healing journal, and I believe was written by a Vet. I can getreprints or more info if anyone desires--I have not used this product to date. Walter Yourchek -------------------- Phone # 888-469-7546; also available thru mail order house IDE(Interstate Drug Exchange) Jerry Bock --------------- For those who have asked me about purchasing Skin Cap:I buy it from IDE Interstate, Inc. Their phone 1-800-666-8100, or fax themat1-800-433-3291. Mark Valentine --------------- I had my pharmacist mix up a number of different formulations ofzinc pyrithione. The next step is to see which one works. If oneconsiders azeleic acid: It only works if the mitochondria arefuntioning. On can prove this in bacterial cultures by adding sodiumazide (which kills mitochondria) If one adds sodium laurel sulfate tothe bacteria nothing happens. If one adds azeleic acid nothing happens.If one adds them together the bacteria should lyse (as they do incultures not treated with sodium azide) Again nothing happens. Thisshows azeleic acid is actively transported into the cells, sincestopping the respiratory machinery stops its action. I realize theazeleic acid analogy is odd here but the take home lesson is that thereis probably an interaction between the zinc pyrithione and one of theother ingredients, rather than a pure zinc effect, just as there is aninteraction between azeleic acid and the sodium laurel sulfate. Azeleicacid does nothing by itself. Zinc pyrithione probably doesn't either.I'll let you know when I figure it out. Haines Ely ------------- According to the Psoriasis Foundation, the original Skin Cap Spray containeda steroid as well as ZNP. The steroid has now been removed, and the FDA isinvestigating the product further. Please, you European dermatologists, tellus more about the product. Yelva Lynfield -------------- The source I found was Progressive Labs in Irving Texas-1(800)527-9512.I called them today, and their Spray is about $21 (for3.33 oz) to the Doc. The propellant is butane. They stated that they now have a U.S. version in an environmentally safe pump bottle for about $12.50 for 4 oz.,so I ordered some to try. The article I read (with impressive before and after pictures) was in The Townsend Letter, Jan. 97, and written by Morton Walker, DPM, Stamford, Conn. Anecdotally, I saw a severe psoriatic this am who has been using Skin Cap Spray to one side of her body for two weeks and with very impressive results--I'ma sceptic, but will give it a fair evaluation, and report back later. Walter Yourchek ------------------- I have a sample of "ecological" Skin Cap from Cheminova U.K. Ltd. Customerservice 800 61 spray (77729)It has 2 mg zinc pyrethrone and 1 mg methyl ethyl sodium sulfate per ml. "forrelief of itching, irritation, redness, flaking and scaling associated withskin conditions." No mention of psoriasis. No advice about how often itshould be applied. Kevin C. Smith MD FRCPC ------------------ I have yet to have any patients tell me about it.However, another dermatologist in the group had several patients with good response to it, and about twice that number who failed to respond to it(so he tells me).A lot us us will be at World Congress in Sydney, where presumably we'll hear about anything remarkably good and new. Michael Fetterman ------------------ While this is clearly belaboring the point, I still want to keep talkingabout Skin Cap. I too have now had several patients return/call withglowing reports, including two who were on systemic therapies and are nowoff them, and reportedly clear (in one case, truly clear, confirmed on myexam). I of course see my professional career treating and researchingpsoriasis vaporizing as Skin Cap revolutionizes dermatology. A couplequestions are raised:1. If this stuff is really so good, and has been available in Europefor a decade, why don't European derms talk about this stuff??? Do they know something we don't about toxicity or efficacy, or is this a conspiracy to deprive patients of a drug which would cut their practices by 50%? (see Dr. Crutchfield's original post in which he states it'seffective for LP, LSC, atopic derm, seb derm, etc etc). I wish we could get more feedback from Europe: anyone visiting over their soon?2. If it truly is this good, I believe this represents a pharmacologicalparadigm shift which would be equivalent to proving that homeopathic remedies are indeed effective. Mind-boggling to claim that zinc pyrethione can do all of this.3. It also would essentially negate the unbelievable volume of research into diseases such as psoriasis, as it is hard to believe a simple productlike this works through traditional immunological or microbiological mechanisms.Keep me in touch with any comments or experiences you all have with this stuff, directly or via the list. Thanks! Mark Ling, M.D., Ph.D. -------------------- Mark, Our friend and semi-guru, Al Kligman, says that everything works at least once in dermatology. That may be what's going on here. It is hard to believethat ZPT in teensy concentrations would not help dandruff (look what happenedto the effectiveness of Head & Shoulders when P&G lowered the conc of ZPT)but would clear psoriasis. Guy Webster ---------------- Mass spec or NMR would be dandy, but liquid chromatography cheaper and more readily available in any highschool chem lab.I'd suspect something like that, but even so, TCA in my hands is no miracle drug. Michael Fetterman ------------------- Also have had a couple of psoriasis patients come in with "glowing"reports of clearing with Skin-Cap-one in particular claimed to have required mtx in the past, but now controlled with Skin Cap. My response was to provide a sample of DHSshampoo with Zinc(label states contains 2% ZNP) and to compare.Patienthas not returned so I'm assuming complete satisfaction. Pierre Jaffe, MD ------------------- Just opened my Jan-Feb 1997 issue of JGD(J Geriatr Dermatol1997;5(1):21-4) byCrutchfield et al titled "The effective use of topical zinc pyrthione inthe treatment of psoriasis: a report of three cases.Impressive photos depictingsignificant and rapid improvement. Possible mechanisms discussed.Is itthe zinc? or is it the vehicle?is it the combination of the above?A funread on a gloomy saturday afternoon. Pierre Jaffe, MD ----------------- Would someone with patients responding to Skin Cap please check a few serum zinc levels and report back to us. I wonder how much uptake the patients are getting through the skin and by inhalation. Hope there is no heavy metal or arsenic in the spray (arsenic of course works great for psoriasis but hasfallen from favor because of a poor long-term side effect profile).Maybe look for adrenal suppression too - that might pick up an obscurecorticosteroid derivative that could be missed if you didn't know what tolook for on the mass spec / gas chromatography. Kevin Smith ------------ When we discussed Skin-cap, I think I told you that the ZNP bar is great forseb derm, and that I started to recommend it to psoriatics. About half adozen of my chronic plaque psoriasis patient have returned for followup afterusing the bar for a month, and neither the patients nor I was impressed withits action except as a shampoo. Yelva Lynfield, MD ----------------- Read "The Effective Use of Topical Zinc Pyrithione in the Treatment ofPsoriasis: a Report of Three Cases" published in The Journal of GeriatricDermatology Jan/Feb 1997 by Chas. Crutchfield et al from the Univ. of MinnesotaDept. of Derm. In this peer-reviewed journal they describe dramatic successwith Skin Cap Spray used b.i.d. on one side vs. triamcinolone oint. or placeboointment on the other. In one case, near clearing occurred in 8 days. They havea bigger study underway.Like everyone else, I was surprised but this product does seem efficacious.They did acknowledge that other ingrediants like the propellant may be afactor. Philip Hughes, M.D. ------------------- I saw a patient today who I have been treating for psoriasis for severalmonths. He had failed to improve on Dovonex or Temovate or a combination ofboth and had many inflammatory, eruptive, and pruritic lesions all over thebody. I started him on Tegison two months ago at a low dose, 25 mgm daily,and raised the dose to 25 mgm BID one month ago. Two weeks ago, whilevisiting his psoriatic aunt in Puerto Rico, he was given a can of Skin Cap. He used it only on the left leg below the knee. The change was dramatic. The right leg had improved no more than 25% on Tegison whereas the left legwas completely clear! I don't know how this stuff works, but it seems towork better than almost anything in our current armamentarium. Isaac Novick, MD ------------------ No personal or clinical experience with Skin-Cap, but one of the other guys in the group says he had several patients show phenomenal clearing of scalp psoriasis and seb derm with it..but then found that like lots of other products, was helpful for maybe an estimated third of patients. Michael Fetterman ------------------ May I hear from anyone who has seen a failure to respond to Skin Cap? Also, how about side effects? And success in non-classic plaque psoriasis? The manufacturer claims a success rate of 85%, and I think this may beaccurate, as I've seen four patients with negligible benefit out of the fortyor fifty patients who have tried it in my practice, and it is safe to assumethere are a few more failures out there who have yet to report back to me.No one has discovered any side effects yet. I intend to check zinc levels on any patients who are steady users of large quantitities of the stuff, buthaven't yet had the opportunity. Anemia from copper deficiency is the only theoretical side effect I am aware of.I haven't tried it on pustular or erythrodermic cases yet. I have anerythrodermic PRP patient and a refractory lichen simplex chronicus patientwho are trying it, but no reports yet on results. I also don't know how itperforms on palmoplantar areas yet. Scalps respond well to it. We've sent afew patients home with the pump-spray formulation from Progressive Labs tocompare with Skin-Cap, but again too early for any feedback. Mark Valentine -------------- I am delighted to see some feedback regarding the Skin Cap-typeformulation from Europe, where these zinc pyrethione products haveapparently been available for years. I am still struggling with theconcept of a product which is 85% effective, according to a recent post,yet which has not apparently swept Europe by storm. I've given about 40or 50 of my most recent psoriasis patients over the last month info reSkin Cap so I presume in a month or two I'll have more substantiveexperience to report. More European comments?? Mark Ling, M.D., Ph.D .------------------ In Germany there is a product called "Capsoft Regulativ-Spray".I don¥t know if it is identic to Skin cap, but it containsZink-Pyrithion like this. Unfortunately I have no personally experiencewith this product, but i read about it in "Pso Magazin", the journal ofa german psoriatic group. Several psoriatics write about their badexperiances with Capsoft. They describe it as skin irritating.Dermatologists of the University of Hamburg saw four cases withpsoriasis pustulosa after use of capsoft. Andreas Eisenmann --------------- It certainly isn't the zinc pyrithione in Skin Cap which makes it work. Ihave mixed up gels, liquids, and creams with varying strengths of ZPwithout much effect compared to the brand name stuff. I deleted themessage about the propellant of Skin Cap spray so I couldn't ask theauthor to e-mail me directly but I am extremely curious. What is it?Haines ElyI just got back from visiting Vanderbilt Psoriasis Center. Nurses statethat results with Skin Cap Spray have been mixed but generally positive.They state that many patients have been more impressed with a productcalled Apis. I am getting more information.Anybody heard of it? Trey Truett, MD ------------------- Isopropyl myristate is a synthetic oil found in many cosmetics, and in fact in some acne topicals, I think! I knew a dermatologist who thought it to be comedogenic.My money is on the sodium methyl ethyl sulfate, or some moiety derived from it, as being the (still) secret ingredient. Can anyone here comment on (potential) carcinogenicity of alkyl sulfates ? Michael Fetterman ---------------- This might help those of you who are running literature searches:In my handy Sigma chemical catalog (every derm office should have one - mineis kind of old - 1988) isopropyl myristate is listed as: myristic acid ethylester (a synonym is: ethyl myristate).Myristic acid has a synonym: tetradecanoic acid.In 1988 isopropyl myristate sold for 24.70 / 100 g for the 99%, and 24.00 /liter for the 95%. Certainly much cheaper in bulk. Kevin C. Smith MD FRCPC --------------- Isopropyl myristate is "Liquid Wrench" I think it is also a maincomponent of WD40. It is the agent which induces perioral dermatitis inmost makeups sold as "oil free". What a coup! Thank you sooo much forthis information. Liquid wrench is a lot cheaper! Haines ElyIndeed, I believe there was a tabloid story a year or two ago about WD40 for psoriasis. I believe everything I read. Haines Ely ------------ Don't you believe the zinc has anything to do with it? Will you have yourpatients put on Head & Shoulders and spray with WD40? (is it really trueabout WD40 or is this just another "urban" myth?). Eliot Mostow ------------- As I mentioned in a previous note I've had my pharmacist mix up zincpyrithione in every vehicle I can think of with only minimal results. Imight add, only the solution with added B6 had any effect. Haines Ely ------------- Hans, as far as I can see, FK-506 have very different properties. FK-506 works as a topical agent on psoriasis. Cyclosporin doesn'teven work when injected intralesionally in Psoriasis. Rhett Drugge, M.D. ------------------- After noting the possible association between Skin-Cap and WD40, one of our Rheumatologists told me that many of his arthritis patients spray WD40 on an inflammed joint and get temporary relief of pain. He believes it works but also thinks that it may have caused one case of neuropathy. Today, I recieved my first mass mailing for ordering Skin-Cap. The need for credible data on safety and efficacy is clear! John Melski MD ------------- I hope it is forthcoming. However, I was able to speak with someone at theFDA dermatology division Thursday, and she wasn't able to tell me much. Iasked if I might be kept abreast of any investigation into the safety of SkinCap. Apparently it is strictly against FDA regulations torelease any information whatsoever about investigations or new drugapplications that are pending. She was categorically unable to even discloseif Skin Cap currently has any applications filed with the FDA. My concernsabout patient safety seemed to not count for much in the FDA scheme ofthings. She suggested I contact the office on Advertising and Communicationsand lodge a complaint because of the illegal advertising for psoriasiswithout an FDA indication. This I am not prepared to do. Knowing how theFDA works, they would probably determine that it was entirely safe, and thenproceed to confiscate all the product, since they value form over function bya 10 to 1 margin.Meanwhile, my first feedback (one patient only) on the zinc pyrithione sprayfrom Progressive Labs in Texas is that it is not effective, at least whencompared with Skin Cap. This is as Haines predicted. I also saw threepsoriasis patients yesterday who, much to my dismay, failed to see muchbenefit from Skin Cap. Mark Valentine ----------------- I recently had a patient in with psoriasis resistant to topical therapies but as it was not too severe she did not want to try anything else...yes, she was in last week clear, using skin cap...as her lesions did not respond to temovate it makes me wonder, despite a biopsy consistent with psoriasis, if we are not dealing with more than one cause of psoriasis, even though the clinical/histological pictures are the same...so that type 2 for example, may be steroid/mtx/etc resistant but skin cap responsive... any comments?... Steve Emmet -------- Well, I've finally bowed to my own curiosity and started to use Skin Cap Spray. Just a few patients, paired comparisons with one side being treated in the usual fasion for that patient, and the other with Skin Cap...very informal, careful observations and phone calls.Preliminary thoughts...impressive results. Some of the " light patients " with resistant areas have cleared. The untreated areas, no change. Patients on Mtx with some residual plaques...cleared on the treated sides, no change on the other. No experience yet with nail problems, looking for more date on scalp psoriasis.Continuing to study, more information in a few weeks. Elliot Puritz ------------- Skin Cap seems to be working ok here in south hemisphere,too. One 75 yr oldpatient with widespread psoriasis had some control,before,but taking manydrugs,etc. Like magic, his only 15 days applying S cap has lead him to morethan 50% clearing - we are all amazed! He complains of the price, but he'svery happy.Hope you don't find any bad thing about this product. George Leal ------------ Dear all,one of my psoriatic patients brought me today the insert of SKIN CAP, newlymarketed in Brazil (supposedly the same). It says- "S Cap is a modernproduct, made of A TENSOACTIVE (METHYL ETHYL SODIUM SULPHATE) THAT HASANTISEPTIC AND KERATOLYTIC PROPERTIES (ELIMINATES EXCESS OF EPIDERMIS IN ALARGER THAN NORMAL SCALE). THIS TENSOACTIVE RECEIVES A POTENCIALIZATIONFROM ZINC PIRITHIONE, that reforces ist antibacterial and antifungal actions(alas , decisive for the control of the affection).I am doing a little research on methyl ethyl sodium sulphate, but so farunproductive. George Leal ------------- I have received the following communication from Richard Faiola, M.D.,Medical Director of "Noble Products, Inc." a Distributor of Skin Cap in theU.S. According to the letterhead he is a family practice doctor andmanaging partner of L.G. Steck Memorial Clinic in Chehalis, WA. Subj: Re: Skin CapDate: 97-03-10 02:52:57 From: FaiolaR@localaccess.com (Richard Faiola) To: WHWoodII@aol.com Per the manufact. they have appropriate registration with FDA and anational drug identification # (its on the package). FDA "approval" of aspecific product like SkinCap is not required and has neither been soughtnor granted. Its ingredients are from among those for which the FDA haseither granted a "generally recognized as safe" designation or has apermissive "monograph" on. In other words, manufactures are free to usethe ingredients of Skin Cap without specific additional FDA review. It isan OTC product. It does not require New Drug Application, norsafety/efficacy data when labeled for the cosmetic indications of"Dandruff" and "Seborrhea." They can not label it for the medicalindication of "psoriasis" The FDA removed "the heartbreak of psoriasis"from the cosmetic to the medical several years ago. That does not mean Ican not share with me colleagues its utility for symptoms associated withthat disease, but our consumer advertising will be careful to make clearthat it is for the symptoms of "itching, flaking, inflammation" associatedwith various skin disorders. A double blind placebo controlled study isbeing completed in now, by an American researcher, independent of thecompany. I believe, but have not first hand confirmation that the resultsare confirmatory. The researcher had a bit on the Internet 2 or 3 weeksago, responding to a question, and reported the results as promising andalso that he expected to be presenting to the Derm meeting in SanDiego. The company sponsored some studies in Latin America--I have reviewed them. They showed good results, but they do not meet my own or usual scientificstandards. The active ingredients are those listed in my letter. ZincPyrithione, sodium laurel sulfate (an irritative detergent in toothpasteand several other hygiene products. There is some alcohol and otherpresumed inactive excipients and propellants. The zinc portion is, ofcourse, the same as in "Head and Shoulders." I personally believe the SLSfacilitates the absorption of the zinc, while acting as a directkeritolytic (SLS has been shown to permit the dangerous absorption ofnickel transdermally in foundry workers, no known studies directly on zinc,but then unlike nickel zinc is a desirable nutrient). Bottom line: Thestuff is relatively cheap compared to some of our other options, looks likeit should be reasonably safe, and IT WORKS. About 50,000 persons are orhave used it in the US ---------- i have a very cooperative japanese patient with basically total body psoriasis, untreated, (mentioned as i don't know if japanese skin may respond differently from caucasian)...who used skin cap bid on one arm and temovate cream bid on the rest of his body...at three weeks of temovate and two weeks of skin cap, the skin cap was clearly better, with flatter plaques, less redness, less itching.... Steven D. Emmet, M.D. --------------- Another glowing report. 55 year old with 25-30% surface area psoriasissince l959, recalcitrant to many rx's in the past including PUVA. CLEARafter one month, and 6 cans, of Skin Cap aerosol. No kidding.IWe will see if it will be the second non-prescription drug put on theformulary. The first being Unibase. Diane D Thaler --------------- A few weeks ago I suggested to a half-dozen psoriasis patients that they tryLiquid Wrench on their psoriasis ( eg. Wal-Mart, $4.99, mostly isopropylmyristate) and the first one came back yesterday -- happy lady: not amiracle, but considerably improved. Kevin C. Smith MD FRCPC -------------------- Another glowing report for Skin cap spray here also........56 yo recalcitrantpsoriatic who we have been keeping maintained with modified Goeckermantherapy, topical steroids and dovonex. One week and two bottles of skin capspray and she is TOTALLY CLEAR...........I am impressed!I have just place 5 more patients on it and will report later. Jeff Marmelzat ----------------- ... personal experience. I've given SC to between 50 and 100 patientsover the last two months. My experience is that it is an unbelievablyeffective drug for a SUBSET of patients, perhaps 50% in my estimation.They get dramatic clearing, often within a few days of starting, andwithin a month generally are to the point where it's tough to see wherethe psoriasis used to be. Phenomenal. Others simply don't respond, or evendevelop a significant irritant dermatitis. I worry about the stuff a lot,since I don't believe it's just another Head and Shoulders, but it is soeffective that at least until someone demonstrates potential toxicity itis hard for me to justify not using it. Still, I'm keeping my ears open.The demand is so great now that the Nova folks are 4 weeks back ordered.Finally, I had some patients try a "knock-off" in a pump spray bottle. Wassupposed to be just as good as SC. It was 100% ineffective, a totalfailure. BTW, the local distributor, a former patient, apparently admittedto one of my current patients who had tried the knock off, that he hadbeen forced to start using "real" SC again to control his psoriasis Mark Ling, M.D., Ph.D. -------------------- I understand that there is good efficacy and tolerability in early trialswith calcipotriol (know as calcipotriene in the US) in an isopropyl myristatebase for scalp psoriasis.Isopropyl myristate is of course the same stuff found in Skin Cap. It is saidto greatly enhance permeability of the scalp to calcipotriol. Kevin C. Smith MD FRCPC ---------------------- the steroid rumor has surfaced with Skin-Cap repeatedly: I think thearchives may contain prior discussion. Dr. Crutchfield at U. Minn. has hadit analzyed with GC and clearly states there is no steroid peak identifiable. That of course does not mean that Skin-Cap might not cause striae. Mark Ling, M.D., Ph.D. -------------------- For those who may have missed out on the earlier discussion, Skin Cap is anOTC spray product that contains zinc pyrathione (the stuff in Head &Shoulders shampoo) in an organic base that is largely isopropyl myristate.Apparently this base is important for allowing penetration of the zinc tothe deeper layers of the epidermis. This product is manufactured byCheminova International Laboratories and distributed in via the Internet byNet Nova Pharmaceuticals (http://www.clearskin.com/).The spray works dramatically in somewhat more than half of patients withplaque-type psoriasis when sprayed on bid. An interesting facet of it isthat the severity of the problem doesn't seem too much of a factor inwhether someone will be good responder or not, meaning it may work on someof your severe longstanding problem psoriasis patients that don't respondwell to much else.I know it sounds like a con game, but it is true. When it works it's betterthan Temovate (works faster too) and (so far) doesn't seem to have thetachyphylaxis problems of topical steroids. It is cheaper to buy in largequantities, so if you are going to start recommending it, you might do yourpatients a favor by being their volume purchaser and reselling it to themat near cost.The toxicity of this preparation has not yet been studied very well,although Zinc is one of the least toxic metals (compared with Cadmium,Mercury, Arsenic, etc.), and has even been used orally to treat a number ofdiseases in the past including Wilson's disease [1-3], cirrhosis [4], andsickle cell anemia [5] to name a few. Dermatological diseases that havebeen treated with it include acne (doesn't really work very well) [6-10],chronic mucocutaneous candidiasis [11] and interestingly enough, psoriasis[12]. Before you all run out and put your psoriasis patients on oral zincsulfate, please note that this double-blind trial with 25 patients wasunsuccessful. 600 mg/day of oral zinc sulfate is fairly well tolerated withmainly GI side effects, so I am assuming for the moment at least that thisSkin Cap stuff is not going to be too toxic. As well as it works, it's notgoing to go away unless it turns out to be a lot more toxic than Ianticipate, however. Somehow this got by the FDA, I suppose because zinc pyrathione had been around and shown to be safe (Head & Shoulders shampoo).However the Cheminova base is a whole 'nother ballgame and turns zincpyrathione into a sure 'nuff potent topical drug. Stay tuned. References: 1. Hartard C, Kunze K: Pregnancy in a patient with Wilson's diseasetreated with D-penicillamine and zinc sulfate. A case report and review ofthe literature. European Neurology 34(6):337-40, 1994. 2. Heckmann JM, Eastman RW, De Villiers JC, et al.: Wilson's disease:neurological and magnetic resonance imaging improvement on zinc treatment[letter]. Journal of Neurology, Neurosurgery & Psychiatry 57(10):1273-4,1994. 3. Shimon I, Moses B, Sela BA, et al.: Hemolytic episode in a patientwith Wilson's disease treated with zinc. Israel Journal of Medical Sciences29(10):646-7, 1993. 4. Marchesini G, Fabbri A, Bianchi G, et al.: Zinc supplementationand amino acid-nitrogen metabolism in patients with advanced cirrhosis.Hepatology 23(5):1084-92, 1996. 5. Gupta VL, Chaubey BS: Efficacy of zinc therapy in prevention ofcrisis in sickle cell anemia: a double blind, randomized controlledclinical trial. Journal of the Association of Physicians of India43(7):467-9, 1995. 6. Cunliffe WJ, Burke B, Dodman B, et al.: A double-blind trial of azinc sulphate/citrate complex and tetracycline in the treatment of acnevulgaris. British Journal of Dermatology 101(3):321-5, 1979. 7. Michaelsson G: Oral zinc in acne. Acta Dermato-Venereologica.Supplementum Suppl(89):87-93, 1980. 8. Orris L, Shalita AR, Sibulkin D, et al.: Oral zinc therapy ofacne. Absorption and clinical effect. Archives of Dermatology114(7):1018-20, 1978. 9. Weimar VM, Puhl SC, Smith WH, et al.: Zinc sulfate in acnevulgaris. Archives of Dermatology 114(12):1776-8, 1978. 10. Weismann K, Wadskov S, Sondergaard J: Oral zinc sulphate therapyfor acne vulgaris. Acta Dermato-Venereologica 57(4):357-60, 1977. 11. Polizzi B, Origgi L, Zuccaro G, et al.: Case report: successfultreatment with cimetidine and zinc sulphate in chronic mucocutaneouscandidiasis. American Journal of the Medical Sciences 311(4):189-90, 1996. 12. Burrows NP, Turnbull AJ, Punchard NA, et al.: A trial of oral zincsupplementation in psoriasis. Cutis 54(2):117-8, 1994. Mark Naylor, M.D. ------------------ this is an updated report. The patient is the "elevated sgpt psoriasispatient",presented in these lists weeks ago, to whom I started SKIN CAPSPRAY. I AM COMPLETELY AMAZED!!!!!! ASTONISHED! - with just one week of thespray use, he GOT RID OFF ALL HIS LESIONS, SCALP AND BODY!!!! I saw himtoday,he is completely "clean", and we are all very happy! And he hasn'tapplied it for 2 weeks.We are also happy he doesn/t have to take Mtx (or anything else),so far.I hope this thing doesn't cause tachyphylaxis,or anything else, for it wasfantastic. I have some other patients using it,yet to come back.Thanks George Leal Dear Drs. Crutchfield, I have had an excellent success with the few patients to whom I haverx Skin Cap Spray. Now I ask you, once achieved this result, how do youprescribe maintenance therapy? I have told them to apply the spray once aweek, in the places that had the lesions before. Have you seen tachyphilaxis? George Leal -------------- Skin cap spray has produced an acneiform eruption in several of my patients whenused on the face or neck. Not surprising after all the talk about commoningredient in WD 40, Liquid Wrench and Skin Cap Spray. Philip Hughes, M.D. -------------- Diane - there is a primary irritant contact dermatitis that occurs from timeto time with skin cap - I've seen it in one caregiver who developed itwithin 48 hrs on forearms where some of the mist settled - cured by usinglong sleeves and greater care.Other notes on Skin Cap.Local WalMart now has it behind the counter - too much stock "shrinkage"from folks taking a five-finger discount. How many little cans could you fitin *your* pocket or purse? The sign of a successful product, I guess.Helpful money-saving hint. Spray a bit on a china saucer, use a finger toapply dabs quickly to areas you don't want to spray ( e.g. spots on face orguttate lesions or even the returning spots when the disease wants to comeback). If worried about contact, wrap applying finger in SaranWrap then dipand dab.I have now treated three DLEs (BID x 2-4 days then 1/day x a few days thewait and watch) and two non-specific intertrigos in males (single spraytwicw a week only - done in the office for good control and so I can watchcarefully the results. Bill Danby -------------- I now have one patient with extensive psoriasis who is using Skin Cap insome areas & Liquid Wrench in others. She feels there is some efficacy ofLiquid Wrench & she reports that both products have an identical feel onthe skin. However, the Skin Cap appears to be the more effective product. Jerry Bock ----------- I have had a number of patients develop acneiform eruptions (acne venenata) from Skin Cap Spray, which isn't surprising. Philip Hughes, M.D. ----------------- Just an update on my experience with SkinCap. I stock it so as to provide my patients with their first can ( charge $30). I have arranged for a local pharmacy to carry it and ask pts to get more there. I explain that I do not know why it works, and despite lack of knowledge about all the ingredients, have not heard any significant comments from those on this list about serious side effects.The patients are uniformly reporting favorable effects on scalp, body and hands. I have not seen any significant side effects, except for a little dryness in some cases. Jerry Eisner -------------- I've been following the Skin Cap discussions with interest, and havepurchased some and am now having some patients use it. These are allpatients I've seen for years, and who have resistant psoriasis. Theseare the kind of patients we all have a lot of: good patients who havetried many therapies (of all sorts, including the "big guns"), and whoremain active, and difficult to treat.I just got a marvelous letter from a young man with very widespreadpsoriasis who tells me his psoriasis is better now (after one week) oftherapy, then ever before.I asked him to come into the office, and guess what: he's spectacularly better. I have never seen any response in any psoriasis patient like this in 22 years of practice! Ican't wait to hear from other patients. I'll let the group know about the follow-up. As for now I stand amazedand delighted!Had another lady come into the office to show me the effects of Skin Capon her widespread and very chronic scalp psoriasis (which has notresponded well to topical steroids, tars, acid preps, etc. over theyears).After 5 days of use she is clinically almost totally clear of PSO. She and I are pleased andastonished. Robert I. Rudolph, M.D. ------------------- Has anyone seen (not heard of) any significant untoward reaction that they believe is more likely than not due to Skin Cap? I have not seen any. Jerry Eisner >>So far naught but an occasional complaint of stinging in over 225 canssold.....One of my most impressive responses: A man with severe pustular psoriasis ofthe hands, with marked swelling, secondary anonychia, and inability to evenbutton a shirt or zip a zipper, had been completely disabled by his diseasefor at least 8 years, and essentially unresponsive to MTX, PUVA, topicalsteroids, and Dovonex. Symptoms reduced to mild peeling with two cans ofSkin Cap...... Mark Valentine -------------- In response to the question of adverse reactions to Skin Cap: We (I and Drs. Lewis and Zelickson) are currently conducting a 60 patient double blind, vehicle controlled study on the treatment of topical zinc pyrithione spray (skin cap) for psoriasis. We published the results of pilot studies in the Jan/Feb issue of the J. of Geriatric Dermatology (they accidentally reversed the before and after photos-so please "reverse them back" if you read the article), and recently spoke at the clinical research symposium of the American Academy of Dermatology (San Francisco, 1997) and presented at the Society of Investigative Dermatology (Washington DC, 1997) and have a published report that can be viewed on the Dermatology Online Journal;web address: http://matrix.ucdavis.edu/DOJvol3num1/zinc/zinc.html Essentially, in our clinical experience of well over 100 patients, in about 5-10% of patients we have seen a very mild and transient flare of the psoriasis that falls off in the first 1-3 days. I warn my patients about this and tell them to treat through it, unless it becomes severe (which it has not, as of yet). About 20% of patients complain of dryness and/or irritation. For the dryness, I recommend a moisturizer of choice about 1 hour after applying the Skin-Cap. For moderate to severe irritation, I recommend just QD applications. I have had 1 or 2 clinical patients stop using due to irritation. None of the study participants have left the study for adverse reaction reasons. There is a post healing erythema that is replaced by post-inflammatory pigmentation that fades with time. Although I have not personally seen it, I have heard of reports of tachyphylaxis-like reactions from colleagues. Additionally, there have been reports by users on the psoriasis support groups of what they term as a "rebellious psoriasis", i.e. red papules and possibly pustules arising at the periphery of healing plaques. The only explanation that I have for this, (since I have not personally seen it), is a koebnerization reaction secondary to irritation of normal skin included in the "treatment spray area". I have had a few patients who have significant improvement to a point, but don't totally clear. The next time this happens I'll be tempted to try combination therapy (add a potent steroid or Dovonex, or both). I have not tried combination therapy to date, but this may be a good group to try it on. Has anyone else tried combination therapy? I have seen a small group of patients who, with compliant BID applications, don't start to respond until week 5 or 6. For this reason, I don't consider anyone a treatment failure unless they have compliantly adhered to a BID application for 8 weeks.We'll have more to say as we conclude the study (August 1997)and analyze the results. We are also looking at the treatment of psoriatic nails by BID applications above the nail matrix, and also looking at periodic, treatments (once or twice per week) to cleared "trouble areas" to reduce or prevent future flares. We are also initiating cellular studies with Mark Pittelkow at the Mayo Clinic to get a better understanding of the cellular mechanisms of action.What are others experience with the tachyphylaxis/rebellious reactions??? I donít know if there is a "safe" limit to the surface area that can be treated. Cost seems to be the limiting factor at this point.Has anyone had any luck treating palm/plantar pustular psoriasis?? I've had a good response in 1 patient of 2, with a 3rd patient being evaluated currently.What about keratoderma blennorrhagicum? (I haven't tried it on this condition, yet). I have also used it very successfully on lichen planus: 4 of 4 patients with near to total clearing, with a 5th patient being evaluated currently.I understand that there will be several other "knock-off" zinc pyrithione sprays available soon. I'm happy to hear of this, especially if they work. Competition is good, and hopefully will drive the price down, a complaint I constantly hear from my patients who have to pay the OTC price of $30-40 a can, and who can easily go through several cans to gain control.I enjoy reading about the experiences of others, good and bad, of this interesting treatment. Iíll share additional information concerning our research, with the group, when appropriate. Charles Crutchfield III, MD ------------------------ The isopropyl myristate of Skin-Cap is a proven comedogen. However that does not make it "the mechanism". It is fairly well proven, I think, that the major route of penetration of topical agents is via the follicles however.If we can assert that zinc pyrithione under occlusion is capable of this dramatic result in psorisis and other inflammatory dermatoses, then it would be a cheap study to see if topical zinc pyrithione and other comedogens or occlusive dressings do the job.I doubt it.Certainly the isopropyl myristate content along is basis to avoid acne prome regions. Michael Fetterman -------------- I have been using Skin Cap for several months and so far the results areremarkable. In my opinion Skin Cap blocks a step very high up in the cascadeof events that gives rise to a psoriatic plaque and thereby stops the wholeprocess cold. All the other medications we use act to suppress psoriasis atthe end of the cascade. When we find out how it works we will probablyuncover something very basic in the pathogenesis of psoriasis.I order Skin Cap in bulk from Acu-Derm and sell it to patients at cost. Itell them that if the medication works they can order it themselves. Thetoll-free number is on the box. Do I feel bad about giving patients a medication of whose mode of action I amignorant? No, because the vast majority obtain quick and complete relieffrom a bad disease that I have not been able to give them using variousexpensive medications all of which have their own set of side effects. Idon't think I could, in good conscience, start a psoriatic patient onTegison, Methotrexate, PUVA, Cyclosporin, Hydroxyurea, or even UVB withouttrying Skin Cap first. Isaac Novick, MD ------------------ I just wanted to alert the members of some information I became aware of last night. According to an article published in De Telegraaf, May 29, 1997, the Minisrty of Health of the Netherlands pulled Skin-Cap off the market because it was discovered to contain a potent steroid. Early in 1996, Skin-Cap was banned from the Austrian market because if was found to contain high levels of triamcinalone (~0.5%). I received the Austrian information from a posting to a psoriasis support group by the Canadian Distributor of Skin-Cap (her name is Patricia Cross, email address:pcross@rideau.carleton.ca). According to an official cheminova company statement, a few lots were accidentally "contaminated" with triamcinalone. They were unsure how this happened and plan to try to reintroduce it back into the Austrian market sometime in the future. Concerning the Netherlands- Recently, a high ranking official at the National Psoriasis foundation did telephone and speak with an official at the Ministry of Health in the Netherlands who was involved with the case and was told that the steroid found was clobetasol proprionate!We are currently finishing a 60 patient, double blind, vehicle controlled study on the use of topical zinc pyrithione (s. cap) to treat psoriasis. Naturally, we were concerned and very interested in this development. Because of early rumors of steroids(which recently went fom rumor to fact by the cheminova/Canadian statement) , we did test the study samples for triamcinalone (HPLC and nmr) and found NO triamcinalone. It is my understanding that it is very difficult to detect any random steroid- it must be looked for specifically, a time consumimg and costly fishing expedition if one is to be thorough, which certainly was beyond the scope of our study. The company stands by its statement that U.S. Skin-Cap contains only: zinc pyrithione, isopropyl mysristae, propel 45 (iso-butane) and sodium-lauryl-sulphate (although initally they claimed that the sodium-lauryl-sulphate was "sodium-methyl-ethyl-sulphate", a situation which is still confusing. I have sent a letter (fax) to Cheminova today (June 13, 1997) asking for an explanation of the Netherlands events and to, once again, confirm that the U.S. product does not contain steroids of any kind. Has anyone seen immediate blanching, steroid atrophy, or tachyphylaxis-like reactions in s. cap patients? I have not, (but I have heard of a few tachy reactions).Does anyone else have any insight into this interesting situation? I will keep the group updated on the response and any additional information that I come across. We will now try to check for clobetasol proprionate, as I am sure others (FDA, etc) will also. Charles Crutchfield ----------- I'm sure all dermatologists have prescribed triamcinolone and clobetasol for a dozen years or more in the hopes of containing and trying to "cure" psoriasis. Has it ever worked? Has it ever worked like Skin-Cap? Never!I have, as we speak, discharged 14 psoriasis patients, some of whom have had their ailment for more than 30 years. I either have discharged them, or they call me and tell me they are cured. And they thank me and some say they pray for me. And these same patients have used, on and off, all the potent steroid creams, ointments, lotions, and sprays, including clobetasol (Temovate -- cream, E-cream, ointment, gel and scalp application). With little, if any, significant results.So if there are a few "drops" of clobetasol in one (or more) of these sprays, how do you account for the almost immediate relief -- subjective and objective -- of psoriatic patches? And thick scalp psoriasis? And you all have used clobetasol, haven't you? Have you gotten similar results?There has to be another answer. Meanwhile, I'm happy that many of my patients are happy with their results. Jerry Litt. ------------------ I can only say that I have never had the results with clobetasol, Dovonex,methotrexate, whatever, that I am seeing with Skin Cap.I have used it successfully on dyshidrotic eczema of the hands that wouldnot respond to clobetasol.I most recently am using it on an elderly woman with intertrigenouserosive and pustular psoriasis. I believe the acute episode was triggeredby her diabetes,indwelling urinary catheter with infection, and possibly yeast. She wasinsevere pain from the erosions and we placed her in the hospital. I amapplying Skin Cap once daily in this area. I am also using Tegison 25mg,IVCipro, oral Diflucan, and topical Desonide (once daily). Within 24 hoursher pain was resolved. Within 48 hours her pustules are resolving and theerythema fading. Whatever is in this stuff, the benefits outweigh therisksso far. The patient thinks I perform miracles. Keep us posted. Jerry Eisner ------------------ I agree with Drs. Litt and Rudolph, I've never seen anything work like skin-cap. Including our study, Iv'e used it in well over 100 patients with only a handful of failures. I've used it against psoriasis (monotherapy and combination therapy with the residual plaques of MTX and PUVA), lichen planus (ESPECIALLY LP-see previous posting), atopic dermatitis, LSC, prurigo nodularis, etc. I have had patients cry in my office at their results!!! The same story we all have had-20 and 30+ years without relief, now clear!!!Yes, I've used triamcinalone and clobetasol p., but I've never used TMC at 0.5% in a novel/unknown liquid vehicle. Same with clobetasol p.-and as we well know, the vehicle can have a tremendous effect on the potency of a steroid, not to mention if the steroid is at higher concentrations than currently used. I don't know how much clobetasol p. was found in the Netherlands version, but I never intended to imply that it was just "a few drops".The facts are plain, and I certainly agree with Drs, Litt and Rudolph, I've never seen any current steroid in use work like s.cap. Assuming that the U.S. version does not contain steroids (and we have not found any steroids in it), we are intiating cellular research with M. Pittelkow at the Mayo Clinic to better elucidate the mollecular mechanism of action.In addition to conducting the only double blind, vehicle controlled, skin-cap study, I've wrtitten papers on skin-cap, spoken at the AAD, and presented at the SID and other medical conferences. I, as well as any other dermatologist, and all of my patients that have benefitted from skin-cap, really wish for the best for skin-cap. I'm happy to have it at my disposal, I use it often, and my patients are delighted. I just thought I would be derelict in my duties if I did not alert the group to the Netherlands and Austrian incidents. If skin-cap works so great, why would they put clobetasol p. in it???? I'll keep the group posted on any new findings.Thanks for your comments. I share your enthusiasm and curiosity. Charles Crutchfield ------------------ I have noticed that several pharmacies in my area are now carrying it,probably as a result of Mark V's and my proselytizing to our patients.However, prices vary from $35 to $45 a can. Mark, a pharmacy in Stanwoodis charging $45 according to one of my patients. Jerry Eisner ------------------ After last comments concerning skin cap I decided to make a trial in two ofmy most unresponsive patients affected of localized scalp psoriasis. It worked in 2-3 days to clear their patches. After using it for 14 days Itold to use it 2 days per week for two more weeks and then stop.I'm really impressed. I wonder how much time will they be free of lesions.Any of you have experience in relapsing times. And what to do in the caseof tachifilaxis? Toni Azon. Cambrils. Spain. ------------------ I can only say that I have never had the results with clobetasol, Dovonex,methotrexate, whatever, that I am seeing with Skin Cap.I have used it successfully on dyshidrotic eczema of the hands that wouldnot respond to clobetasol.I most recently am using it on an elderly woman with intertrigenouserosive and pustular psoriasis. I believe the acute episode was triggeredby her diabetes,indwelling urinary catheter with infection, and possibly yeast. She wasinsevere pain from the erosions and we placed her in the hospital. I amapplying Skin Cap once daily in this area. I am also using Tegison 25mg,IVCipro, oral Diflucan, and topical Desonide (once daily). Within 24 hoursher pain was resolved. Within 48 hours her pustules are resolving and theerythema fading. Whatever is in this stuff, the benefits outweigh therisksso far. The patient thinks I perform miracles. Keep us posted. Jerry Eisner ------------------ Does anyone doubt the credibility of this company?Could arsenic, mercury or some other toxic heavy metal account for the observed effects? Steve Feldman, MD ----------------- In reference to Dr. Smith's post, below, I certainly agree with him, and, as I have posted to the group on several prior occasions, Skin-Cap is extremely effective against LP,( probably as effective against it as it is against psoriasis!). I have tried it on about 10 cases and, without fail, it has worked and given me some of the most happy patients. I recently tried it on hypertrophic LP of the shins and in 3 weeks it worked like magic! (I have before and after photos).BUTas I have recently posted, Skin-Cap was found to contain clobetasol proprionate in the Netherlands!!! Please see that post for details. We have not found steroids in the U.S. version, although we did not look for c.p. specifically. We are now. I'll keep the group posted. Charles Crutchfield ------------------ Tried Skin Cap on a lady whose LP resisted EVERYTHING including PUVA,Vesanoid, intralesional and topical corticosteroids and she's greatlyimproved.I warned her that there are no studies, and no safety data. She is willing toaccept potential unknown and unquantifiable risks. Kevin C. Smith MD FRCPC ------------------- Skin cap has been sold for a long time in Spain. Patients use it morethan dermatologists. It¥s said that it contained a corticosteroid sometime ago, but the formulation changed later. Dermatologists that haveused it for some time say that it works the first times, but it shows atachyfilaxis effect. Ignacio G. Doval ------------------ The past 2 days I have seen 3 patients whose psoriasis no longer responds toSkin Cap Spray. These were all initially dramatically responsive. They haveused it 6-8 weeks. Sounds like tachyphylaxsis in these uncontrolledobservations. Philip Hughes, M.D. ------------------ I have one tachyphylaxis out of about 30 Skin Caps that I know of. Guy Webster ------------------ This is the other shoe everyone has been waiting to drop. So far my 100+patients on Skin-Cap have not noted tachyphylaxis, but I was veryinterested in the comments of the Spanish dermatologist in this regard.I'd love to hear of similar cases, and will post if mine find this too. Mark Ling, M.D., Ph.D. ------------------ I have also seen Skin Cap Spray tachyphylaxis. Perhaps the role of Skin Cap Spray (SCS) will ultimately be as a adjuvant to ultraviolet light as the SCS quickly clears the opaque scale of psoriasis. Rhett Drugge, M.D. ------------------ After distributing 2 cases of skin cap my anecdotal experience I about 75% response. Thick plaque and scalps the best, hands the worst. So far notachyphylaxis but because of prior po stings I am expecting it. Allerganrep was introing tazarotene and made reference to rumors of toxic productsin skin cap--is this going to be the drug co's defence instead of ascientific analysis? It seems somewhat magical for some of the patients. L.J. Gregg,M.D., ------------------ Here at the Canadian Derm meeting in Newfoundland there's lots of talk andspeculation about Skin Cap. A lot of people have stories about wonderful andvery rapid responses, including discoid lupus, lichen planus, intertrigo,perianal dermatitis, and inflammatory acne (a week before the Prom).Several have mentioned that Dr. Crutchfield, his derm department and U. of MNare being sued or threatened with a lawsuit by the US distributors of SkinCap, perhaps because they tried to make a copy of Skin Cap. What are thefacts, and will this affect the publication of the results of Curtchfield'scurrent large study on Skin Cap?I wonder if Skin Cap, which may be the most potent topical anti-inflammatorythe world has ever seen, would be useful for contact dermatitis (eg. poisonivy), vitiligo or alopecia areata.Does anyone know of a medication as potent as Skin Cap which is devoid ofside effects? I'll bet that in the fullness of time problems will bereported. At this meeting are several mentions of striae and hypertrichosis KC Smith MD FRCPC -------------------- I did clinical trials of terbinafine in onychomycosis for Sandoz. One of ourrecorded Adverse Drug Reactions was a florid case of tinea versicoloronsetting, if memory serves, after about two-four weeks on terbinafine. Ibelieve (but cannot prove because M. furfur is everywhere) that if you havepsoriasis *and* you are allergic to your M. furfur population - terbinafinewill trigger psoriasis through the intermediary reaction. Bill Danby -------------------- At the Canadian Derm there was discussion about our liability forrecommending Skin Cap, in view of the fact that it is a VERY potent topicalbroad-spectrum anti-inflamatory and perhaps immunosuppressive. Othermedications which are as potent or even less potent (eg. clobetasolproprionate) can cause serious side effects, and it is thought likely thatwhen long-term safety and efficacy data becomes available problems with SkinCap will emerge. (Sort of like the way we are now seeing serious problemsemerge with the "Fen-Fen" drug combination for obesity.)In the case of Skin Cap, we do not have data from the usual basic science,animal work, Phase I, II, and III studies, and post-marketing surveillancethat we are accustomed to with virtually all of the other drugs and physicalmodalities that we use in dermatology.In addition, the distributors of Skin Cap have showed no interest inproviding this type of data, and have been evasive and un-cooperative.In spite of all of the above, we are responsible (and probably liable) forour recommendations with regard to Skin Cap, just as we are for any otheradvice we give.In the case of Skin Cap, we do not have the control associated with aprescription medication, because we cannot cut off the supply of medicationif we think it should be stopped. The patient can purchase Skin Cap over thecounter, but we are still liable (even though we don't have control) if werecommended Skin Cap.It was suggested that we make up some sortof "Skin Cap information and consent form", which would bring the aboveissues to the patient's attention, and make clear the extent (if any) towhich we take responsibility for their use of Skin Cap and for theconsequences which may flow from that. This might also help the patientsunderstand why we are reluctant to recomend Skin Cap, or to take theassociated responsibility for its use. Here is my first draft, for yourcomments and additions:"Skin Cap information and consent "FOR: (patient name) DATE: __________Skin Cap is a VERY powerful broad-spectrum anti-inflamatory and perhapsimmunosuppressive combination of chemicals which can be applied to the skin.Other medications which are as potent or even less potent (eg. clobetasolproprionate - Temovate, Dermovate) can cause serious side effects such asthinning ofthe skin, excessive hair growth and sometimes crippling problemswith the bones and joints and other body systems. We do not know whatproblems may develop after long-term (or in some cases even short-term)exposure to Skin CapIn the case of Skin Cap, we do not have data from the usual basic scienceresearch, experiments on animals, or research studies on humans, andfollow-up research that we are accustomed to with virtually all of the otherdrugs and other treatments that we use in dermatology. None of the othertreatments we use in dermatology have "secret ingedients" of the sort claimedfor Skin Cap.In addition, the distributors of Skin Cap have showed no interest inproviding this type of safety and effectiveness data, and have been evasiveand un-cooperative.In spite of all of the above, I am responsible (and probably liable) for myrecommendations with regard to Skin Cap, just as I am for any other advice Igive you.In the case of Skin Cap, I do not have the control associated with aprescription medication, because I cannot cut off the supply of medication ifI think it should be stopped. You can purchase Skin Cap over the counter, butI may liable (even though I don't have control) if I recommended Skin Cap.For these reasons, I am making a record in your chart that I am NOTrecommending Skin Cap in your case. If you decide to accept the uncertain andpossibly serious problems which could be associated with using Skin Cap Iwill be happy to continue helping to take care of your skin problems, but Iwill not accept responsibilty for any problems Skin Cap causes you. YOU SHOULD NOT USE SKIN CAP if you are not willing to accept the risks andproblems (including risks and problems we are not aware of yet) which couldbe associated with using Skin Cap.If you decide to use Skin Cap, please keep a diary of when you start and stopusing Skin Cap, the amounts you use, the other medications and treatments youuse in addition to Skin Cap, and the areas you apply it to. Please keep me informed of your progress. If you have problems related toSkin Cap please let me know and I will try to help you. Once again I remindyou I AM NOT RECOMMENDING THE USE OF SKIN CAP, AND I DO NOT ACCEPT ANY RESPONSIBILITY FOR ANYTHING (GOOD OR BAD) THAT COMES FROM YOUR USE OF SKINCAP. KC Smith MD FRCPC -------------------- Even with your concerns, it does not have to be couched in this manner. What I dislike most about it is that you are actually recommendingsomething to a patient while telling them that you are not reallyrecommending it- so as to avoid any responsibility.I share my concerns with patients verbally and document the conversation. I tell them I do not know all the substances in Skin Cap and that I can nottell them anything about possible future dangers. I also tell them thatthis is indeed amazing stuff, but should be used carefully. I have even hadsome patients buy respirators (painting filters) at the hardware store sothey don't have to breathe fumes when applying it. I promote the use of Skin Cap because so far it seems safer than lots ofthe internally applied meds, and more effective than most topical ones.I document my notes as to the discussion. Jerry Eisner -------------------- Re the FDA status of Skin Cap:based on my personal understanding as well as conversation with Dr. J.Wilkins at the FDA Liaison Task Force meeting at the Academy meeting, itis my belief that Skin Cap is not in any effective manner "FDA-approved,"despite advertising to that effect. It is currently marketed OTC based onthe listing of zinc pyrethione as the active ingredient. Any product usingzinc pyr. as its active can make claims that it is generally recognized assafe and effective for seb derm/dandruff (but NOT for any other conditionincluding psoriasis, again despite at least one distributor's advertisingto the contrary). The big question is that given the extraordinary efficacy of this productthere is the possibility that this still needs to be regarded as a newdrug, and thus would necessitate filing of an NDA with all the attendantclinical testing. Of course, since the product is not patented, I suspectthat the manufacturer would never foot the multimillion dollar cost offiling an NDA, and thus may lead to a strange situation where Skin Capbecomes an illegal drug. We'll see: I suspect the FDA will make a decisionin the next year. Mark Ling, M.D., Ph.D. -------------------- I had a patient appear in my office three weeks ago with erythrodermicpsoriasis. The story was that he had mild plaque psoriasis for many yearsand had controlled himself with OTC tar and other preparations. He is in hislate sixties and prior to a trip from Rochester, NY, to "the middle ofnowhere," Tennessee, he had experienced a mild flare up of the disease butduring his stay with relatives down there he had flared terribly and had indesperation driven himself back home. When I saw him, he had 70% of the bodycovered with erythrodermic psoriasis. I started him on Soaks andtriamcinolone ointment after noting to him that he had significant evidenceof stasis change on the lower legs and extracting from him a history of theproblem starting to flare on the legs suggestive that the long trip hadflared an underlying stasis tendency as the cause of the psoriatic flare. Hereturned partially improved in one week and I gave him a single dose of MTXto attempt to "cool off" the still persistent areas on the legs. He was muchbetter on the third visit and decided to forego the second dose of MTX. Thisweek (two days ago) he returned with a significant flare up of one arm andsheepishly told me that prior to leaving for Tennessee he had purchased a canof Skin Cap spray OTC at the suggestion of a friend and was using it for thesmall flare that started prior to his trip. He continued to use it down inTennessee even when he began to flare. On his return to Rochester he hadstopped the Skin Cap when he came to me and started on the soaks andtriamcinolone but after he had improved he tried the Skin Cap on the one armand had experienced a terrible flare there over the next twenty-four hours. I've seen a number of dramatic responses to the Skin Cap and this is thefirst dramatic side effect. Pat Condry -------------------- Excellent. Much less self-defensive. Very informative for the patient. Furthermore, your attempt has given me the stimulus to try some ideas for a form of my own. I would like permission to borrow some of your ideas. I have only two suggestions for your form which I have included below. I remove the categorical statements about Skin Cap's power, since we admittedly do not know how it works - remember, it just might be quite benign compared to some of what we already use. Penicillin was once a radically powerful drug against bacteria, and except for severe allergy, has little physiological effect.---- Jerry Eisner -------------------- Excellent. Much less self-defensive. Very informative for the patient. Furthermore, your attempt has given me the stimulus to try some ideas for a form of my own. I would like permission to borrow some of your ideas. I have only two suggestions for your form which I have included below. I remove the categorical statements about Skin Cap's power, since we admittedly do not know how it works - remember, it just might be quite benign compared to some of what we already use. Penicillin was once a radically powerful drug against bacteria, and except for severe allergy, has little physiologicaleffect. Jerry Eisner -------------------- Here in Brasil we have the same trade mark : "Skin Cap" in shampooand spray ( that contains Zinc Pyritione ) and a lot off pacients areusing by their owns for Psoriasis, because they can buy it very easily. We don't have yet serious studies about this product and in fact I'mafraid of using it. MARILUCE D. MOLL , MD. -------------------- "the medicine is FDA approved, or at leastit is not disapproved. Thus, legally, the medicine can be used withsome modicum of safety."I love Dr.Smith's analogy of fuel oil and fertilizer also being safe independently and unsafe when mixed. OTC products do not give the same assurances of safety as prescription drugs. The FDA says that in general, Zinc pyrithione is safe in certain concentrations. Companies can then market it in those concentrations without any study of their product's safety. Noone may know if the actual formulation, with whatever so-called inactive ingredients, is safe because there could be unknown interactions between the active ingredient and the inactives.In the US, one guarantee of safety is the reputation of the manufacturer. When you buy Tylenol brand acetominophen from the McNeil/J&J, you know it's going to be safe. They have a lot to lose if it isn't. Do you think you have the same degree of assurance when buying Skin Cap? I don't.When the product is as potent as some here are finding, there must be something going on. It concerns me. I relay that concern to patients thinking about using the product and am very reluctant to recommend the product as that would give the patient the impression of safety (based on my good reputation instead of the company's [perhaps this is the safety equivalent to my concerns about efficacy when recommending an alpha hydroxy acid product]).Still, I agree that a consent form is over doing it.(BTW, I asked one of the toxicologists at the local cigarette company to do a toxicology study on some Skin Cap. I put some in a plastic tube for him. He picked up the stuff and took it back to his lab. Unfortunately the stuff ate through the plastic before he could study it. The solvent must not have been compatible with the plastic. We'll try again tomorrow with a glass container.) Steve Feldman, MD -------------- Thanks to all who helped with the refinement of my Skin Cap Info Sheet. Hereis the final version, which should contribute to the informed consent processand at the same time reduce the risk of misunderstandings that could lead to litigation:"Skin Cap information sheet "FOR: (patient name) DATE: __________ Recently some patients have been asking about a product called Skin Cap (andabout some other similar products). I have prepared this information sheet tohelp you decide whether or not you are willing to accept the risks andproblems which could be associated with your decision to use Skin Cap.Skin Cap is a mixture of chemicals including methyl ethyl sulfone (also knownas isopropyl myristate) and zinc pyrethrone. The individual chemicals (methylethyl sulfone and zinc pyrethrone) are considered to be reasonably safe whenapplied to the skin, but the risks of applying the mixture of chemicals soldas "Skin Cap" are unknown.Skin Cap appears to be a VERY powerful broad-spectrum anti-inflamatory andperhaps immunosuppressive combination of chemicals which can be applied tothe skin. Skin Cap seems to reduce inflammation in a number of unrelated skinconditions, including psoriasis, lupus, and lichen planus. Other medications which are as powerful as Skin Cap or even less powerful(eg. clobetasol propionate - Temovate, Dermovate) can cause serious sideeffects such as thinning of the skin, excessive hair growth, and occasionallymay even cause crippling problems with the bones and joints or other bodysystems if not used properly. Medications which are as powerful as Skin Capgenerally have the ability to cause serious problems under somecircumstances.Because Skin Cap is not a prescription medicine we do not have informationfrom the scientific studies, experiments with animals, or experiments withhumans which are available for virtually all of the other medicines and othertreatments that we use in dermatology.Because medical and scientific information on Skin Cap is not available:1. We do not know how Skin Cap works.2. We cannot predict what kinds of problems may develop after long-term (orin some cases even short-term) exposure to Skin Cap. 3. We do not know if there is a safe limit to the amount of Skin Cap whichcan be applied every day.4. We do not know if there is a safe limit to the number of days or weeksSkin Cap can be applied.5. We do not know if there are some parts of the body where Skin Cap shouldnot be applied. 6. We do not know if Skin Cap might make some diseases worse (for exampleskin infections or skin cancer).7. We do not know if there are some people (for example children, pregnantwomen or old people) who may be at increased risk for problems if they areexposed to Skin Cap.Because Skin Cap is not a prescription medicine, it is not required to bemanufactured to the same high standards we expect of prescription medicines,and the manufacturer of Skin Cap may deliberately or accidentally change the amounts and types ofchemicals in Skin Cap without telling anyone.Because there are a number of unanswered questions and unknown risks mostpeople prefer to avoid using Skin Cap for the time being, but there are a fewpeople with very bad skin conditions which are not reponding adequately toordinary treatment, and in some of these cases people are willing to acceptthe possible risks and unknowns associated with using Skin Cap.YOU SHOULD NOT USE SKIN CAP if you are not willing to accept the risks andproblems (including risks and problems we are not aware of yet) which couldbe associated with using Skin Cap.If you decide to use Skin Cap, please keep a diary of:1. when you start and stop using Skin Cap2. the amounts of Skin Cap you use3. the other medications and treatments you use in addition to Skin Cap4. the areas you apply Skin Cap to. 5. The lot number (printed usually on the bottom of the can), in case thereare changes from batch to batch in the mixture of chemicals in Skin Cap.Please bring this diary when you come to see me, so I can take it intoaccount when I am working with you.When you return for followup visits please keep me informed of your progress.If you have problems which might be related to Skin Cap please let me knowand I will try to help you. KC Smith MD FRCPC ------------------- As I pointed out, the good news about Skin Cap is that: "Skin Cap seems toreduce inflammation in a number of unrelated skin conditions, includingpsoriasis, lupus, and lichen planus." I have no doubt that Skin cap isEFFECTIVE in many cases, and I have seen patients respond remarkably well toit. My concerns are related to short term (weeks to months) and long-term (monthsto years) adverse effects. I think that it is very important for my patientswho are considering Skin Cap to be aware of the many issues concerning thesafety of Skin Cap which have not been dealt with yet. Basically, thisinformation sheet is an attempt to help them cover THEMSELVES, and minimizeTHEIR risks, because if Skin Cap related problems develop THEY will be theones who suffer.Zinc pyrithione as a single agent is relatively benign (and relativelyimpotent) when applied to the skin. The comparison of Skin Cap with the zincpyrithione in Head and Shoulders is misleading. Skin Cap is a mixture ofchemicals, and the effect of this mixture is completely different from theeffect of zinc pyrithione when it is used as a single agent.Skin Cap appears to be AT LEAST AS POTENT AS THE MOST POTENT TOPICAL STEROID CREAMS, and I am suggesting that generally in medicine potent medications can also cause serious side effects in some cases. I listed as an example of this some of the problems steroid creams can cause, and I am suggesting that Skin Cap MAY eventually be found to cause equally serious (but perhaps different) side effects. The information that patients and physicians require in order to make informed decisions about the safety of Skin Cap is not available. Because the safety of Skin Cap is unknown, it is not possible to accurately weigh the risks against the benefits.It is important for people considering the use of Skin Cap to be aware of vast lack of information about Skin Cap.I am comparing medications in terms of their clinical effects, not in termsof their chemical composition.I would be very reluctant to prescribe a medicine with so many unanswered questions, and I certainly reluctant to recommend Skin Cap until safety data (comparable in quality to data on the other equally potent medications I prescribe) is available. The short reports in the Online Journal of Dermatology and in the Journal of Geriatric Dermatology fall far short of meeting my needs (and the needs of my patients) for safety data. It is correct that the formulation of Skin Cap has been changed from time to time by the manufacturer, and some formulations of Skin Cap have been banned in some countries in Europe after being found to contain corticosteroids (and the presence of corticosteroids was not disclosed on the label). The company now claims that the presence of corticosteroids was an "accident". Such sloppy manufacturing practices, and lack of final quality control, are unacceptable for products seeking my recommendation.With regard to ASA - we know a lot about how ASA works, and we also know a lot about ASA's risks, interations with other treatments, indications for use and contraindications. If I had as much information about Skin Cap as I have about ASA I would be much more comfortable recommending Skin Cap to my patients.I got some email from Dr. Crutchfield a couple of days ago. Dr. Crutchfield has terminated his relationship with the distributors of Skin Cap. The study he is working on will be completed in the Fall, and may be published some time in 1998. The issues of long term safety and of adverse interactions of Skin Cap with previous or concurrent treatments will not be addressed in that study .KC Smith MD FRCPC -------------------- "Skin Cap information and consent "FOR: (patient name) DATE: __________ Recently some patients have been asking about a product called Skin Cap (andabout some other similar products). Skin cap can be very effective incontrolling a number of unrelated inflammatory skin conditions, includingpsoriasis, lupus and lichen planus. I have prepared this information sheet tohelp you decide whether or not you are willing to accept the risks andproblems which could be associated with using Skin Cap.Skin Cap is a mixture of chemicals including zinc pyrithione and possiblyalso sodium methyl ethyl sulfate and / or isopropyl myristate. The individualchemicals (zinc pyrithione, sodium methyl ethyl sulfate and isopropylmyristate) are considered to be reasonably safe when applied to the skin. Thesafety of this MIXTURE of chemicals is unknown.Some people think that because Skin Cap has "the same active ingredient asHead and Shoulders Shampoo (zinc pyrithione) it is as safe as Head andShoulders ..." This may not be a safe assumption. In the same way that relatively benign things like ammonium nitratefertilizer and fuel oil can be mixed to create an explosive, so it ispossible that sodium methyl ethyl sulfate and zinc pyrithione have beencombined to produce a very potent medication with properties and riskscompletely different from the individual components.The beneficial effects of Skin Cap are very different from and much greaterthan the effects produced by other zinc pyrithione containing products, andit is possible that Skin Cap may turn out to produce harmful effectsdifferent from and greater than those caused by other zinc pyrithionecontaining products. Skin Cap appears to be a VERY potent broad-spectrum anti-inflamatory andperhaps immunosuppressive combination of chemicals. Medications which arevery potent generally also have a greater ability to cause serious problems. Other medications which are as potent as Skin Cap or even less potent (eg.clobetasol propionate - Temovate, Dermovate) can cause serious side effectssuch as thinning of the skin, excessive hair growth and occasionally may evencause crippling problems with the bones and joints or other body systems ifnot used properly. It is certainly possible that when more information isavailable Skin Cap will be found to cause equally serious (but perhapsdifferent) problems in some cases.Some people think that because "tens of thousands of cans of Skin Cap arebeing sold every month, and there has been little news of problems, Skin Capmust be pretty safe." This may not be a safe assumption.Because Skin Cap is not a prescription medicine the manufacturer anddistributor are not required to maintain a detailed record of reports ofadverse reactions to Skin Cap. Because animal and human experiments andfollowup studies of the quality necessary for prescription medicines have notbeen done, it is very likely that the number, severity and kinds of adversereactions to Skin Cap have not been adequately identified and publicized.Because Skin Cap is not a prescription medicine we do not have theinformation from the laboratory experiments, experiments with animals, orexperiments with humans that are available for virtually all of the othermedicines and other treatments that we use in dermatology.Because medical and scientific information on the safety of Skin Cap is notavailable:1. I do not know how Skin Cap works.2. I cannot predict what kinds of problems may develop after long-term(months to years) or in some cases even short-term (days to months) exposureto Skin Cap in your case. 3. I do not know if there is a safe limit to the amount of Skin Cap which canbe applied every day.4. I do not know if there is a safe limit to the number of days or weeks SkinCap can be applied.5. I do not know if there are some parts of the body where Skin Cap shouldnot be applied. 6. I do not know if Skin Cap might make some diseases worse (for example skininfections or skin cancer).7. I do not know if there are some people (for example children, pregnantwomen, or old people) who may be at increased risk for problems if they areexposed to Skin Cap.8. I do not know if there could be an increased risk of problems (forexample, skin cancer) if Skin Cap is used in combination with or followingother treatment, such as ultraviolet light, methotrexate, cyclosporine orcorticosteroid creams.9. I do not know if inhaling traces of Skin Cap while it is being sprayed, orabsorbing it though the skin, could cause internal problems. For example, itis possible that the potent anti-inflammatory and possibly immunosuppressiveeffect of inhaled Skin Cap could increase the risk of yeast infections in themouth and airway, and perhaps also increase the risk of dangerous lunginfections like Pneumocystis carinii. The animal and human experiments whichare necessary to deal with these issues (and which would have been requiredif Skin Cap was a prescription medication) have not been done.Because the risks of Skin Cap are unknown, it is not possible to accuratelyweigh the risks against the benefits.Because Skin Cap is not a prescription medicine, it is not required to bemanufactured to the same high standards we expect of prescription medicines,and the manufacturer of Skin Cap may deliberately or accidentally change theamounts and types of chemicals in Skin Cap without telling anyone.Because there are a number of unanswered questions and unknown risks most ofmy patients prefer to avoid using Skin Cap for the time being. There are afew people with very bad skin conditions which are have not respondedadequately to better understood treatments, and some of these people arewilling to accept the possible risks and unknowns associated with using SkinCap. If you decide to use Skin Cap, please keep a diary of:1. when you start and stop using Skin Cap.2. the amounts of skin Cap you use.3. the other medications and treatments you use in addition to Skin Cap 1.when you start and stop using Skin Cap.4. the areas you apply Skin Cap to. 5. The lot number (printed usually on the bottom of the can), in casethere are changes from batch to batch in the mixture of chemicals in SkinCap.Please give me a copy of this information when you come to see me, so I cantake it into account when I am working with you.Please keep me informed of your progress, If you have problems related toSkin Cap please let me know and I will try to help you. YOU SHOULD NOT USE SKIN CAP if you are not willing to accept the risks andproblems (including risks and problems we are not aware of yet) which couldbe associated with using Skin Cap. KC Smith MD FRCPC -------------------- Thanks for the information about the chromatographic analysis of Skin Cap.It still doesn't explain the spectacular results which I've been personally seeing in the chronic psoriatics who have been using the product.I've used super-potent steroids, and other high potency steroids, under occlusion, and in every other way imaginable, and never saw results like I'm presently seeing. There must "be something else" which is responsible.I'm telling my patients that I don't know what's in Skin Cap, that we don't know about any long term side effects, and we have no information about rebound. I tell them of the results in other patients, and then tell them they can try it if they like. When I mention the product, they've virtually all heard about it, and many were already using it. I've recently seen it in a mail order catalogue.Despite our concerns many of the patients remain thrilled, and wish to keep using the product.The final disposition will be interesting for all concerned!Robert I. Rudolph, M.D., FACP -------------------- I'll reiterate that my patient/scientist did blind analysis and found Nosteroid, only zinc pyrithione and isopropyl myristate. He took can Igave him and gave it to a colleague w/ psoriasis who has had usualresponse (he love it). This IS a bad problem, as we like to know whythings work. I tell patients I'm really tired of people telling me itworks so well, but they keep telling me and I'd be remiss if I didn'toffer them skin cap as an OTC option. I think company may haveproblems re: honesty, but I agree w/ comment below that says steriodsalone just not as good, so why would it work this way here. I agree w/Rhett that psoriasis centers need to respond to our need to understandthis highly effective topical agent. Eliot-- Eliot N. Mostow, MD -------------------- (Changes marked with ***).***"Skin Cap Lack-of-Information Sheet" ***FOR: (patient name) DATE: __________*** Recently some patients have been asking about a product called Skin Cap (andabout some other similar zinc pyrithione-containing products). Skin Cap canbe very effective in controlling a number of unrelated inflammatory skinconditions, including psoriasis, lupus and lichen planus. There are manythings which we will need to learn before Skin Cap can be safely recommended.I have prepared this "lack-of-information" sheet to help you decide whetheror not you are willing to accept the risks and problems which could beassociated with using Skin Cap.Skin Cap appears to be a VERY potent broad-spectrum anti-inflamatory andperhaps immunosuppressive or immune-modulating medication. Medications whichare very potent often also have a great ability to cause serious problemsunder some circumstances. Other medications which are as potent as Skin Cap or even less potent (eg.clobetasol propionate - Temovate, Dermovate) can cause serious side effectssuch as thinning of the skin, excessive hair growth and occasionally may evencause crippling problems with the bones and joints or other body systems ifnot used properly. It is certainly possible that when more information isavailable Skin Cap will be found to cause equally serious (but perhapsdifferent) problems in some cases.Some people think that: "Because Skin Cap has the same active ingredient asHead and Shoulders Shampoo (zinc pyrithione) it must be as safe as Head andShoulders." This may not be a safe assumption. Skin Cap contains extremely small particles of zinc pyrithione. This form ofzinc pyrithione and the manner of application of zinc pyrithione in Skin Capis very different from other zinc pyrithione containing products like Headand Shoulders Shampoo, and the risks of using Skin Cap are unknown.Because the particles of zinc pyrithione in Skin Cap are much smaller thanthose found in other zinc pyrithione containing products the zinc pyrithionein Skin Cap may be absorbed by the skin to a much greater extent. Absorption of zinc pyrithione by the skin may also be greatly increasedbecause Skin Cap is intended to be left on the skin all day ("put-on,leave-on"), while other zinc pyrithione containing products like shampoos areintended to be put on, and then rinsed off after a couple of minutes("put-on, wash-off"). Over the years various formulations of Skin Cap have been marketed in Europeand more recently in North America. In addition to zinc pyrithione, theseformulations have included a variety of chemicals which are collectivelyreferred to in the pharmaceutical industry as "penetration enhancers". Theseare chemicals which are used to increase the absorption of medications likezinc pyrithione by your skin. Because Skin Cap is not a prescriptionmedication the manufacturer of Skin Cap is not required to let you know thenames of the other chemicals (for example, the "penetration enhancers") inSkin Cap.It is likely that extremely-small-particle zinc pyrithione and apenetration-enhancer delivery system have been combined in a "put-on,leave-on" type of productto produce a very potent medication -- Skin Cap --with properties and risks completely different from previously availableforms of zinc pyrithione.Policies which permitted the non-prescription marketing of poorly absorbedlarge-particle zinc pyrithione-containing products for application to theskin for a few minutes ("put-on, wash-off") may not be appropriate for theform of zinc pyrithione being marketed as Skin Cap.The anti-inflammatory effects of Skin Cap are very different from and muchgreater than the effects produced by other zinc pyrithione containingproducts, and it is likely that Skin Cap will eventually turn out to produceharmful effects different from and greater than those caused by other zincpyrithione containing products. Because the effects of Skin Cap on skin diseases such as psoriasis, lupus andlichen planus are vastly greater than and different from the effects of otherzinc pyrithione containing products, and because the absorption of zincpyrithione from Skin Cap by the skin is almost certainly MUCH greater, SkinCap should be regarded as a NEW medicine by patients and physicians, andperhaps also by the goverment agencies which deal with the safety ofmedicines. Some people think that: "Because tens of thousands of cans of Skin Cap arebeing sold every month, and there has been little news of problems, Skin Capmust be pretty safe." This may not be a safe assumption.Because Skin Cap is not a prescription medicine the manufacturer anddistributor are not required to maintain a detailed record of reports ofadverse reactions to Skin Cap. Because animal and human experiments andfollowup studies of the quality necessary for prescription medicines have notbeen done, it is very likely that the frequency, severity and kinds ofadverse reactions to Skin Cap have not been adequately studied andpublicized.Because Skin Cap is not a prescription medicine we do not have theinformation from the laboratory experiments, experiments with animals, orexperiments with humans that are available for virtually all of the othermedicines and other treatments that we use in dermatology.Because medical and scientific information on the safety of Skin Cap is notavailable:1. I do not know how Skin Cap works.2. I cannot predict what kinds of problems may develop after long-term(months to years) or in some cases even short-term (days to months) exposureto Skin Cap in your case. 3. I do not know if there is a safe limit to the amount of Skin Cap which canbe applied every day.4. I do not know if there is a safe limit to the number of days or weeks SkinCap can be applied.5. I do not know if there are some parts of the body where Skin Cap shouldnot be applied. 6. I do not know if Skin Cap might make some diseases worse (for example skininfections or skin cancer).7. I do not know if there are some people (for example children, pregnantwomen, or old people) who may be at increased risk for problems if they areexposed to Skin Cap.8. I do not know if there could be an increased risk of problems (forexample, skin cancer) if Skin Cap is used in combination with or followingother treatment, such as ultraviolet light, methotrexate, cyclosporine orcorticosteroid creams.9. I do not know if inhaling traces of Skin Cap while it is being sprayed, orabsorbing it though the skin, could cause internal problems. For example, itis possible that the potent anti-inflammatory and possibly immunosuppressiveeffect of inhaled Skin Cap could increase the risk of yeast infections in themouth and airway, and perhaps also increase the risk of dangerous lunginfections like Pneumocystis carinii. The animal and human experiments whichare necessary to deal with these issues (and which would have been requiredif Skin Cap was a prescription medication) have not been done.Because the risks of Skin Cap are unknown, it is not possible to accuratelyweigh the risks against the benefits.Because Skin Cap is not a prescription medicine, it is not required to bemanufactured to the same high standards we expect of prescription medicines,and the manufacturer of Skin Cap may deliberately or accidentally change theamounts and types of chemicals in Skin Cap without telling anyone.Because there are a number of unanswered questions and unknown risks most ofmy patients prefer to avoid using Skin Cap for the time being. There are afew people with very bad skin conditions which are have not respondedadequately to better understood treatments, and some of these people arewilling to accept the possible risks and unknowns associated with using SkinCap. If you decide to use Skin Cap, please keep a diary of:1. when you start and stop using Skin Cap.2. the amounts of skin Cap you use.3. the other medications and treatments you use in addition to Skin Cap 1.when you start and stop using Skin Cap.4. the areas you apply Skin Cap to. 5. The lot number (printed usually on the bottom of the can), in casethere are changes from batch to batch in the mixture of chemicals in SkinCap.Please give me a copy of this information when you come to see me, so I cantake it into account when I am working with you.Please keep me informed of your progress, If you have problems related toSkin Cap please let me know and I will try to help you. YOU SHOULD NOT USE SKIN CAP if you are not willing to accept the risks andproblems (including risks and problems we are not aware of yet) which couldbe associated with using Skin Cap. KC Smith MD FRCPC -------------------- Zinc pyrithione as a single agent is relatively benign (and relatively> impotent) when applied to the skin. The comparison of Skin Cap with the> zinc pyrithione in Head and Shoulders is misleading for a number of reasons. I recall somebody in the group sayinghe'd bought ZnP in bulk and it was a cloudy precipitate with ZnP in particleslarge enough to be seen under the microscope. If this is true then SC isnot like this (but the earlier formulation of Derma Zinc was). So eitherthere isn't any ZnP in there or it's in the form of smaller particles.One speculation about the mystical electro/electrolytic/electrophoreticprocessing that the company/distributors has claimed at various timesis that it uses electrophoresis to separate out very small particles andthe large ones are reprocessed in some way. At a guess bulk ZnP couldbe a waxy solid and therefore difficult to create small particles bymilling because of frictional heating. I guess spraying molten ZnP froma vapourizer into water could do a better job, but with a wide rangeof particulate sizes. An electrophoretic step could separate out thereally small ones and the larger stuff could be sprayed again.*If* the ZnP is in the form of smaller particles then its penetrationinto the skin may be a lot higher than normal which leads to worriesabout toxicity.The company line on this one (conversation between Owner Mr Santamartaand John Kender reported in the group by John Kender) is that: Some or all of the mixture produced is subjected to 96 hours of electric current, and that this "bioelectrical process changes the polarity of the molecules".Make of that what you will. It could be flim-flam to cover up secretingredients with no such processing, it could be an electrophoreticstep or it could be true electrochemistry generating a mix of unknowncontents.> Skin Cap appears to be AT LEAST AS POTENT AS THE MOST POTENT TOPICAL> STEROID CREAMS, and I am suggesting that generally in medicine potent> medications can also cause serious side effects in some cases.Ummmm. Steroids have the subtlety of a shot-gun. It's not beyondcredibility that something which works in a more subtle and less potentway, directed at the real cause of the problem, could have a similareffect. You can break a glass by hitting it with a hammer, or by singingat just the right pitch. A hammer will generally do more damage thansinging when used as an offensive weapon.I think this is a tenuous conclusion to draw, although I understand whyyou would wish to make the warning.> I listed as an example of this some of the problems steroid creams can> cause, and I am suggesting that Skin Cap MAY eventually be found to cause> equally serious (but perhaps different) side effects. One that has been reported (and I've had) is skin peeling when used onpalms of hands and soles of feet.> It is correct that the formulation of Skin Cap has been changed from time> to time by the manufacturer, and some formulations of Skin Cap have been> banned in some countries in Europe after being found to contain> corticosteroids (and the presence of corticosteroids was not disclosed on> the label). The company now claims that the presence of corticosteroids> was an "accident". Such sloppy manufacturing practices, and lack of final> quality control, are unacceptable for products seeking my recommendation.A history of the formulations that I've seen. When I say can/box/leafletthese were as supplied to me by the UK distributor over 6 months ago - Ido not know what they say currently. The brochure is a recent one from theUS which was reported to the group by Christian Tice.Abbreviations are as follows: ZnP Zinc Pyrithione SMES Sodium methyl ethyl sulphate SLS Sodium lauryl sulphate IM Isopropyl myristate Alc Alcohol Exc Excipients Prop Propellent 45 yes Listed but of unknown quantity no not listed q.s. Quantity sufficient - added to other listed ingredients to dilute them to the stated quantities Brochure Journal Can Leaflet Box DistribZnP 0.2% 0.2% 2mg/ml 2mg/ml 2mg/ml yesSMES no no no 1mg/ml 1mg/ml yesSLS yes 0.1% no no no yesIM yes yes no no no yesAlc yes no no no no yesExc no no q.s. q.s. no noProp no yes no no no no Distributors at various times have stated that the stuff contains ZnP,SMES, SLS, IM and alcohol though none have ever listed all those ingredientsat the same time.> Skin Cap is a mixture of chemicals including zinc pyrithione and possibly> also sodium methyl ethyl sulfate and / or isopropyl myristate.And/or sodium lauryl sulphate which appears in some formulations in thesame quantities as SMES. The IM may or may not be part of the excipients.Is the term excipients in common medical or pharmacological usage or isit something else they've made up?> The individual chemicals (zinc pyrithione, sodium methyl ethyl sulfate and> isopropyl myristate) are considered to be reasonably safe when applied to> the skin.They are? John Kender could not find a supplier for SMES or safety sheetsfor it. Related chemicals diethyl sulphate and dimethyl sulphate areconsidered carcinogens and toxic. There is, however, strong doubt thatthe name SMES is accurate by any widely-accepted chemical namingconventions. The company's own statement on this via a distributor, in thepast, was: Methyl ethyl sulphate sodium is a compound developed by Cheminova in order to preserve the secret of the formula. This is done to avoid the risk of the product being copied by our competitors. Its structure is quite similar to lauryl sulphate sodium as both have a chain of methylic groups attached to a sodium sulphate salt. This type of substance has tensioactive and antiseptic properties as well as being keratolitic, helping Zinc Pyrithione act against skin disorders and heal the skin.MESS (they like shuffling the elements around) is a lot smaller than SLSand it's a big stretch of the imagination to call them similar even ifthey are homologues.What John Kender did find, after about a year of searching, was a chemicalwhich fit that description very well indeed in terms of physical properties,biological properties and similarity to SLS. This is Tergitol 4 which isinjected into varicose and spider veins and causes an immediate blood clotand the filing on of the vein with fibrous scar tissue. Since P requiresabnormal surface capillaries to support it and this stuff could conceivablypenetrate into surface capillaries it could well be very useful in treatingP.This chemical is acutally an isomer of isopropyl myristate and a lot closerto sodium lauryl sulphate than MESS is. One name for it issodium 2-methyl-7-ethylundecyl sulfate-4.^^^^^^ ^^^^^^ ^^^^^ ^^^^^^^> The safety of this MIXTURE of chemicals is unknown.As far as some of us are concerned, the actual formulation is unknown.Certainly something in there caused the leaflet I have to carry thesewarnings: WARNINGS: Avoid contact with the eyes. If this happens wash immediately with plenty of cold water. SIDE EFFECTS: Allergic reactions may occur. POISONING AND TREATMENT: Acute poisoning due to accidental swallowing: anorexia, anaemia, vomiting. Treatment: stomach washout with saline purgative.Some of those things make a lot more sense if you assume that Tergitol 4is in there. Or maybe was in there. It depends if you believe that theydropped SMES from the ingredients or simply stopped listing it.> Some people think that because Skin Cap has "the same active ingredient as> Head and Shoulders Shampoo (zinc pyrithione) it is as safe as Head and> Shoulders ..." This may not be a safe assumption. Not even if that's the only ingredient in their other than alcohol. Becauseif it is in there at all it's at a much smaller particle size than normalZnP. Toxicity data for ZnP is based on the normal particle size which isunlikely to penetrate the skin.> In the same way that relatively benign things like ammonium nitrate> fertilizer and fuel oil can be mixed to create an explosive, so it is> possible that sodium methyl ethyl sulfate and zinc pyrithione have been> combined to produce a very potent medication with properties and risks> completely different from the individual components.You forgot the electro/electrochemical/electrophoretic processing. 96hours of electrical zapping in some unspecified way or another which issupposedly essential to the process.> Because medical and scientific information on the safety of Skin Cap is> not available:> > 1. I do not know how Skin Cap works.Claimed mode of action is that it zaps a yeast. The same yeast which hasbeen found to cause dandruff and of a related species to the one whichcauses sebohrroeic dermatitis. There are some very convincing med-lineabstracts which indicate that this yeast is a causative factor and that P isan immunological response to a infectious agent which the body cannot getrid of rather than an auto-immune disease. Some of them are realsmoking-gun material (I can mail you copies of the abstracts if you haven'tseen them).There was also an interesting article in Science & Medicine Nov/Dec 96about various arthropathies in which the authors didn't quite committhemselves to saying that many arthropathies thought to be auto-immunediseases are either hyper-immune responses to trace levels of infectionor ordinary immune responses to undetected high levels of infection. Theydo indicate that many more arthropathies may be reactive than is currentlythought.> 2. I cannot predict what kinds of problems may develop after long-term> (months to years) or in some cases even short-term (weeks to months)> exposure to Skin Cap in your case.*If* SMES turns out to be Tergitol 4 then the long-term effects of theodd molecule from each session drifting around the bloodstream could benasty for liver and kidneys.> 5. I do not know if there are some parts of the body where Skin Cap should> not be applied.Palms of hands and souls of feet are a good guess, at least in my experience.I ended up with 1/8" thickness of dead skin on the soles of my feet attachedto raw pink new skin in various places. On the palms of the hands I gotsub-millimetre sized spots of what looked like P. With the palms I figuredthis was what the company called `Rebellious P' and sprayed them more.The spots on the palms grew in size and joined and eventually becamesimilar to the soles of the feet in some ways. Stopping with SC in theseareas resulted in the problems eventually going away.--Paul (Paul L. Allen)The following article reveals the concerns of the dermatologist in Spainwho performed the chromatographic analyses which led to the banning ofSkin Cap Spray from Spain and subsequently the Netherlands. Skin CapSpray's European experience has a track record poor enought to justify KevinSmith's skepticism regarding its usage. I would hope that academic centerswhich are studying psoriasis get to work on this evolving pharmacologic issue in order to protect the public by providing studies which can evaluate theefficacy and safety of exclude the use of Skin Cap Spray. Certainly theissue of safety is not to be trusted to the manufacturer. Rhett Drugge, M.D. -------------------- Dear Dr. Drugge:>>I read in the last issue of Dermatolgy Online Journal an article entitled>"The Highly Effective Use of Topical Zinc Pyrithione in the Treatment of>Psoriasis: A Case Report=2>Charles E. Crutchfield III, M.M.B., M.D., Eric J. Lewis, M.D., Ph.D., and>Brian D. Zelickson, M.D>Dermatology Online Journal: 3(1) : 3 ">I am writting to you as Editor of this Journal because I cannot contact>directly with the authors of this article. I would like tell that the>product tested in this article is a recently introduced in USA>antipsoriatic OTC agent named Skin Cap.>Skin Cap was introduced in Spain 5 years ago and was suposedly only Zinc>Pyrithione in an spray. As the authors of the DOJ did I was very surprised of the espectacular>results of Skin Cap when I used this product in psoriatic patients. I was>so surprised of the good result that I could=B4nt believe that Skin Cap>contained only Zinc Pyrithione. For that reason I ordered an cromatographic>analysis of a sample of Skin Cap. Cromatography was performed in the>Department of Farmacology and Dermatology of the General Hospital in>Valencia (Spain) (you may check this information with Dr. Adolfo Aliaga.>Chairmen of the Department of Dermatology of General Hospital. Avenida Tres>Cruces s/n zip code 46009. Valencia. Fax 34 6 386 29 70).>Cromatographic analysis showed that Skin Cap do not contain zinc pirithione. Skin Cap was actually a combination of triamcinolone acetonide>at 0,5%, neomicyne undecilinate at 2% and salicylic acid at 1%. Sanitary>authorities of the spanish Gov. were advised of this irregularity and Skin>Cap was prohibited in our country. Two years after, a similar problem was detected in the Netherlands, with>the same product. Skin Cap was then analized at TNO in Zeist (Netherland)>Of course, the result of this analysis was the same than in Spain. Skin cap>contained triamcinolone acetonide at high concentration. (This information>can be cheked at>TNO Nutrition and Food Research Institute>Postbus 360>NL-3700 AJ Zeist>phone +31 30 694 41 44>fax +31 695 72 24>e-mail Infofood@voeding.tno.nl)>>If Skin Cap is giving now so good results on the USA, I would like call>attention that Skin Cap could not contain only Zinc Pirithione as>previously was detected in several countries in Europe.>>Please, put all this information in contact with the article authors and>the rest of the DOJ editors. Sincerely yours, Onofre Sanmartin, MD. PhD Dermatologist Servicio de Dermatologia Instituto Valenciano de Oncolog Eda I read with interest Dr. Sanmartin's comments about the discovery of triamcinalone at 0.5% in skin cap in Spain a few years ago (see below). I appreciate him posting this information for us. I have 2 comments for the group:Because of the rumors of triamcinalone in skin cap, we had skin cap tested specifically for triamcinalone and hydrocortisone and found that it contains neither. We are currenly evaluating it for the presence of Temovate, (in light of the Netherlands findings). A few weeks ago the producer of Skin Cap has sent me a fax that clearly states that "the U.S. version of s cap has not, and does not contain any corticosteroid". In my heart, I doubt that (U.S.) skin cap contains steroids. I truely believe that the vehicle is making the big difference. Time will tell.Secondly, our current (40-60 patient) vehicle controlled, double blind study evaluating the topical use of zinc pyrithione to treat psoriasis was initiated almost 1 year ago when this formulation of topical zinc pyrithione was just beginning to be noticed as a very effective treatemnt for psoriasis here in the U.S.. In fact, our reports in the Dermatology Online Journal (http://matrix.ucdavis.edu/Vol3num1/zinc/zinc.html) and J of Geriatric Derm (5(1):21-24, Jan/Feb 1997) are the first peer-reviewed reports of this preparation that we can verify, anywhere. At the time we designed the study, our intent was very simple: To evaluate its effectiveness in a controlled setting (i.e. to rule out a plecebo effect). As far as safety issues, we are looking only at cutaneous side effects during the study period. Long term and systemic safety questions must be addressed in other studies. Our study is concluding next month and we will be submitting the results for publication shortly thereafter. (I can report that no participant has left the study due to adverse cutaneous side effects). We will have a poster at the upcoming NY AAD (with histology and electron microscopy), and I will be giving a talk at the National Medical Association Annual Conference early this August. Charels E. Crutchfield III, MMB, MD -------------------- I admire your capability to maintain a sense of humor given how much flak you've taken for the info sheet. I hope in my comments that Ididn't come off negative or offensive - if so, that was NOT my intent.I really think what you have done is very good, and this latest revisionlooks good to me. Just so you can put me into perspective, I'm a 56year old PhD chemist who has had mostly 'mild' (according to the NPF webpage) psoriasis (1-3%, elbows, knees, scalp, ears, waist, small of theback, chest, scrotum) for the last dozen or so years. Steroidal creams and ointments have at best held things at bay. Mydoctor has run me past Lidex (fluocinonide), Topicort (desoximetasone),Utravate (halobetasol propionate) and of course, good ole'hydrocortisone. For the scalp, we have tried several including Tegrin,Head & Shoulders, Nizoral (ketoconazole), and on my own, I have recentlyfound that Neutrogena T/Gel extra strength seems to have done the best.Given that, and the lack of local availability to find SkinCap, andbeing aware of several other psoriacs who have had some luck with coaltar, I have tried MG217, an over-the-counter from Triton ConsumerProducts which contains 10% coal tar USP, or 2% coal tar. Whilesomewhat greasy, it seems (after 5 days) to be helping.I found a drugstore which CLAIMS it can get SkinCap in 2 days, but If Ican get away with the coal tar, I'll stick with it for the time being.Keep up the good work. Will you be gathering publishable data as aresult of your care? It sounds like medically acceptable literature isstill scanty.Best regards, Ralph Czerepinski ------------------- For what its worth: I have a 3rd yr family practice resident rotatingthru my office thesepast 2 weeks...it so happens he has fairly stable, but widespread plaquetype psoriasis...He has in the past used mtx(describes self as "mtxfailure"),usesa Jordan light box for home therapy.After a discussion of skin-cap andreview of KC's info sheet,he agreed to a pair-comparison-lt arm sites skin-cap,rt arm sitesdermazinc...after approx 10 days both sides improved, " a lot", but weboth give the edge to skin-cap.Also he notes no scent with skin-cap, buta distinct "alcohol"scent with dermazinc.no irritation with either product. Pierre Jaffe, MD --------------------- Cheminova Internacional, S.A.Macarena 14C/. Felix Boix, 828036 MadridSpainFAX 350 92 92Teleph. 359 40 30 - 359 40 54 Annemette Oxholm ---------- At approx 2 weeks now, we both agree that the Skin Cap side has improved even more compared to the Derma Zinc sites.No irritation with eitherside.The skin cap site has no scaling and obviously resolving erythema,where the dermazinc side has persistant but clearly decreasing amounts ofscaling...the FP resident's comment,"Skin Cap is definetly pulling away" .I'll f/u in a couple of weeks. Pierre Jaffe, M.D. --------------- One of my patients managed to get SkinCap spray from a London pharmacy --incidentally in the UK it is NOT an OTC item. She used it for her intractablechronic plaque psoriasis on her legs and it almost cleared. Very impressive.However, she ran out a week ago. I saw her today. The rebound is quite severe,and it reminds me of the rebound patients get with superpotent topical steroids.I shall definitely be going to the archives to look up Dr. K. Smith'sinformation sheet for patients on SkinCap! Melinda Tong, MRCP ---------------- Skin Cap is just getting off the ground here. I had a patient in the other daywho had tried it on her own, improved a bit, then had a terrible flare (theworst she'd been in years).I've sent copies of my Skin Cap "LACK OF INFORMATION" handout to all the localpharmacies, and I'm giving it to my psoriasis patients as they come through,making it clear that this for information and (except in rare cases) I am NOTrecommending Skin Cap. The handout has been much appreciated by the patientsand pharmacies.I am trying it for a few things like vitiligo and alopecia areata.I'm attaching a copy of my handout. Feel free to use or modify it .Kevin C. Smith MD FRCPC - Dermatology -------------------- FOR: ___________________________ DATE: __________ Recently some patients have been asking about a product called Skin Cap (andabout some other similar zinc pyrithione-containing products). Skin Cap can bevery effective in controlling a number of unrelated inflammatory skinconditions, including psoriasis, lupus and lichen planus. Unfortunately thereare many things which we will need to learn before Skin Cap can be safelyrecommended. I have prepared this "lack-of-information" sheet to help youdecide whether or not you are willing to accept the risks and problems whichcould be associated with using Skin Cap.Skin Cap appears to be a VERY potent broad-spectrum anti-inflammatory andperhaps immunosuppressive or immune-modulating medication. Medications whichare very potent often also have a great ability to cause serious problems undersome circumstances.Other medications which are as potent as Skin Cap or even less potent (eg.clobetasol propionate - Dermovate) can cause serious side effects such asthinning of the skin, excessive hair growth and occasionally may even causecrippling problems with the bones and joints or other body systems if not usedproperly. It is certainly possible that when more information is available SkinCap will be found to cause equally serious (but perhaps different) problems insome cases.Some people think that: "Because Skin Cap has the same active ingredient asHead and Shoulders Shampoo (zinc pyrithione) it must be as safe as Head andShoulders." This may not be a safe assumption:1. It is not known whether the zinc pyrithione or the other chemicals in SkinCap is responsible for the very potent anti-inflammatory effect of Skin Cap.Because Skin Cap is not a prescription medicine the manufacturer is not requiredto tell anyone the names of the other chemicals in Skin Cap.2. The anti-inflammatory effects of Skin Cap are very different from and muchgreater than the effects produced by other zinc pyrithione containing products,and it is likely that Skin Cap will eventually turn out to produce harmfuleffects different from and greater than those caused by other zinc pyrithionecontaining products.3. Because the effects of Skin Cap on skin diseases such as psoriasis, lupusand lichen planus are vastly greater than and different from the effects ofother zinc pyrithione containing products Skin Cap should be regarded as a NEWmedicine by patients and physicians, and perhaps also by the goverment agencieswhich deal with the safety of medicines.Some people think that: "Because tens of thousands of cans of Skin Cap arebeing sold every month, and there has been little news of problems, Skin Capmust be pretty safe." This may not be a safe assumption.Because Skin Cap is not a prescription medicine the manufacturer and distributorare not required to maintain a detailed record of reports of adverse reactionsto Skin Cap. Because animal and human experiments and followup studies of thequality necessary for prescription medicines have not been done, it is verylikely that the frequency, severity and kinds of adverse reactions to Skin Caphave not been adequately studied and publicized.Because Skin Cap is not a prescription medicine we do not have the informationfrom the laboratory experiments, experiments with animals, or experiments withhumans that are available for virtually all of the other medicines and othertreatments that we use in dermatology. Because medical and scientificinformation on the safety of Skin Cap is not available: 1. I do not know how Skin Cap works. 2. I cannot predict what kinds ofproblems you may develop after long-term (months to years) or in some cases evenshort-term (days to months) exposure to Skin Cap. 3. I do not know if there isa safe limit to the amount of Skin Cap you can be apply every day. 4. I do notknow if there is a safe limit to the number of days or weeks Skin Cap can beapplied. 5. I do not know if there are some parts of your body where Skin Capshould not be applied. 6. I do not know if Skin Cap might make some diseasesworse (for example skin infections or skin cancer). 7. I do not know if thereare some people (for example children, pregnant women, or old people) who may beat increased risk for problems if they are exposed to Skin Cap. 8. I do notknow if there could be an increased risk of problems (for example, skin cancer)if Skin Cap is used in combination with or following other treatment, such asultraviolet light, methotrexate, cyclosporine or corticosteroid creams. 9. I do not know if inhaling traces of Skin Cap while it is being sprayed, orabsorbing it though the skin, could cause internal problems. For example, it is possible that the potent anti-inflammatory and possibly immunosuppressive effectof inhaled Skin Cap could increase the risk of yeast infections in the mouth andairway, and perhaps also increase the risk of dangerous lung infections likePneumocystis carinii. The animal and human experiments which are necessary todeal with these issues (and which would have been required if Skin Cap was aprescription medication) have not been done.Because the risks of Skin Cap are unknown, it is not possible to accuratelyweigh the risks against the benefits.Because Skin Cap is not a prescription medicine, it is not required to bemanufactured to the same high standards we expect of prescription medicines, andthe manufacturer of Skin Cap may deliberately or accidentally change the amountsand types of chemicals in Skin Cap without telling anyone.Because there are a number of unanswered questions and unknown risks most of mypatients prefer to avoid using Skin Cap for the time being. There are a fewpeople with very bad skin conditions which are have not responded adequately to better understood treatments, and some of these people are willing to accept the possible risks and unknowns associated with using Skin Cap.You should not use Skin Cap unless you are willing to accept the possible risks and side effects (including risks and side effects we are not aware of yet.) If you decide to use Skin Cap, please keep a diary of: 1. when you start and stop using Skin Cap. 2. the amounts of skin Cap youuse. 3. the other medications and treatments you use in addition to Skin Cap1. when you start and stop using Skin Cap. 4. the areas you apply Skin Capto. 5. The lot number (printed usually on the bottom of the can), in casethere are changes from batch to batch in the mixture of chemicals in Skin Cap.Please give me a copy of this information when you come to see me, so I can takeit into account when I am working with you. Please keep me informed of your progress, If you have problems related to SkinCap please let me know and I will try to help you. -------------------------------- How long was your patient using Skin Cap?Had she been on it for only a short period, I wonder if the period before signsof reoccurrence would have been longer than a week if the duration of therapywas longer. My thinking is that reoccurrence following cessation of Skin Captherapy may be similar to reoccurrence post coal tar treatment. It is myunderstanding that the longer one treats with coal tar the longer the periodbefore remission occurs after cessation of therapy and that duration of therapymight be related to knocking out more of the 'activated cells'. The duration ofSkin Cap therapy may or may not relate to the severity of reoccurrence. Anythoughts from the others on the list? Daniel Bucks PhD The contents of this message are the opinion of the sender and do notnecessarily reflect the opinion of Penederm Inc. or its management. ----------------------- I have received several telephone calls today informing me that at the AmericanAcademy of Dermatology Summer Meeting (New York) today, Friday, August 1, 1997,Professor Mark Lewohl, Chairman of the Department of Dermatology of Mt. SinaiSchool of Medicine announced, (in his presentation on the new treatments forpsoriasis) that his department had several cans of Skin Cap analyzed and theywere found to contain the superpotent steroid "clobetasol proprionate" . Iwould assume that the FDA and Federal Authorities are now being notified for theappropriate actions.Has anyone else heard of this report by Dr. Lebwohl? Dr. Crutchfield -------------------- This, if confirmed, is obviously sad news for all of us who have been seeingmarvelous results with this agent. Most of you will agree that Temovate gelnever cleared stubborn psoriatic scalps like Skin Cap does. The silver liningin the cloud is that now the mystery is solved, perhaps one of our orthodoxpharmaceutical companies, maybe even Glaxo, will be able to duplicate theformula and get the stuff FDA approved. I certainly suspect it should bepossible to prove that this formulation is more effective than other forms ofclobetasol currently on the market, and if Tazorac can get away with $200 a tubepricing, then there is clearly money to be made in this arena once the insurancecompanies are in the prescribing loop. Mark Valentine --------------- Even if the FDA were to "crack down" on Skin Cap spray, we might considercontinuing to evaluate similar agents. Many of us have remarked in the pastthat skin cap spray is more effective than high potency glucocorticoidpreparations. Perhaps there is a synergistic effect between the glucocorticoidand the zinc pyrethione. What are the in vitro effects of the combination? Hasanyone tested the combination of these agents to inhibit a lymphocyt