Frequently Asked Questions about Skin-Cap
(with a footnote on Skin Zinc)
What is Skin-Cap?
Skin-Cap is a topical drug manufactured in Madrid, Spain by the pharmaceutical company Cheminova International, for the treatment of skin diseases. It is controversial because its mysterious effectiveness as a temporary treatment for psoriasis is inconsistent with any known formulation of its claimed active ingredient, Zinc Pyrithione. The manufacturer claims that the true formula is secret and has not properly identified all of the ingredients. In 1997, the product was tested and verified to contain a potent steroid at prescription doses. On that basis, it was banned from import and sale by the US FDA. Skin-Cap is currently banned in several countries. Cheminova has refused a USA FDA inspection, virtually ensuring that the restrictions will last indefinitely. Canada apparently reintroduced a non-steroidal version of the product through DermLabs in January 2000, but then discovered that Cheminova was again adding a different superpotent steroid, and banned the product again in March 2000.
Cheminova and its distributors have been defendants in over fifty personal injury suits, yet they continue to illegally promote Skin-Cap. Several clone products have appeared that compound various ingredients with an optional prescription steroid. Despite company claims in 1996 that the product had been in use by 'millions' of European customers for ten years, Cheminova's trademark filing sets the date of first use at 3/15/93. However, Cheminova has sold a product in Spain called AnasilPiel which contains the antifungal neomycin undecylenate plus triamcinolone acetonide .1%, a class 3 steroid. Anasilpiel (translates to non-acetic-skin?) has been on the market since 1982.
Who wrote this FAQ?This info is provided by Ed Anderson who helped create the global alt.support.skin-diseases.psoriasis Usenet discussion newsgroup. Full text search and browsing of the archives is available at the author's http://pinch.com/skin/ page. This non-commercial web site is run as a volunteer effort and its author has no affiliation with any drug companies nor any conflict of interest regarding Cheminova products.
What's the point?
The purpose of this FAQ was originally to be a counterpoint to Skin-Cap advertisements in national newspapers and marketing on the Internet. Since the product ban, the ads still persist on the net in what has become an underground black market. Positive testimonials about Skin Cap are easy to find while reports of adverse effects were often discounted by advocates as random variations of the skin condition due to other causes or as misuse of the product. This may be understandable from the point of view of a euphoric user who has seen his severe skin condition clear for the first time in years and needs to justify continued use of the product. All psoriasis sufferers are looking for a safe, reliable, treatment for their condition. Ignoring adverse effects and recommending the product for general use before it has been safety tested could be potentially harmful to many innocent people.
Isn't the product FDA approved?Despite the marketing claims, the FDA has never acknowledged any approval. Cheminova and its distributors have not provided any support for their claims. Cheminova distributors base their claims on Zinc Pyrithione being allowed by the FDA for OTC drug topical use in certain skin diseases other than psoriasis. The FDA has specifically banned the sale of Zinc Pyrithione for the treatment of psoriasis.
What other companies are involved?
Most notably, one company apparently NOT involved is the the agro and pesticide manufacturer with the original Cheminova trademark in Denmark. The manufacturer, Cheminova Internacional, S.A. in Madrid, Spain, has sold exclusive marketing rights to many overlapping regions. Cheminova America was based in Miami, Florida. That same office is now occupied by EuroExim, with plans to market a similar product line. One of the major dealers was Nova Medical in Fort Lauderdale. Another early distributor was Net Nova Pharmaceuticals in New Jersey, operated by Andy Kanter who vigorously promoted and defended the product in the psoriasis group.
Many other dealers jumped in to make a quick buck, despite the growing controversy over the unexplained effects and evidence of past product fraud and steroid "cross-contamination" by Cheminova Intl. The product was distributed worldwide, with over a hundred thousand customers. Many former Skin-Cap dealers like Dr Richard Faiola now sell "clone" products and many opportunists are willing to compound the less-than-effective zinc pyrithione "clones" with potent steroids, even though the promotion of specific compounded drugs is now illegal. They use "click and print" prescription forms for customers to have their doctors sign before mailing in the order. Most of the clone products are based on private labels of the same Derma-Zinc product sold by Dermalogix Partners in Maine. There are reports that the president of Dermalogix plead guilty to tax evasion in 1997 for hiding money made in dealing illict drugs.
Note that any "clone" promoter who claims to have the same formula as the original Skin-Cap is knowingly making a false and deceptive claim. The true ingredients of Skin-Cap were never disclosed, and the formula has undoubtedly been changed more than once.
One of the earliest clones called DermaCap is still being sold, now with compounded steroids. It is produced by Progressive Labs, and distributed by Nutrimed in Dallas, aka the "American Council on Collaborative Medicine", still promoting Skin-Cap on their Nutrimed website.
In 1998, a "sister" company of Cheminova in Madrid called Catalysis began marketing a product called BlueCap. It is generally regarded as ineffective.Oct 2000 update: The FDA found steroids in Blue-Cap, and has banned the product from import. A July 11 warning letter to Catalysis USA describes the findings in detail.Despite the product ban, Cheminova continues to direct market the product illegally to US customers in US dollars via the nebulous Swisspharma Ltd (actually in Delaware, not Zurich), mail, email, and repeated Usenet promotions. Other web sites in the US such as Unique Image are still actively selling the products without any warnings. (March 2000).
There are reportedly at least sixty individual injury suits pending against Cheminova and its distributors. A June 1999 hearing in Southern Florida will determine whether they will be treated as a class action. The author of this FAQ is not involved in any suits, and has no further details. Try contacting the NPF for a referral. One firm that announced their involvement has an online web site listing MDL-1243 as the Multiple District Litigation case number.
What are the true ingredients?
Only Cheminova knows the true ingredients, and they change the formula often. Early reports and pharmacy info from Spain indicate that Skin-Cap originally contained triamcinolone acetonide and neomycin undecylinate. An analysis of a doctored study used by Cheminova clearly shows that references to these drugs were removed from the document, and replaced somewhat randomly with either "zinc pyrithione" or a fictional chemical called "methyl ethyl sodium sulfate". These are the active ingredients listed on the first cans to appear in the USA. When Cheminova was asked through its distributor to identify this chemical, it was likened to sodium lauryl sulfate, and the ingredient was promptly removed from the label. They also disclosed that the product contained isopropyl myristate.
Zinc pyrithione, an esentially insoluble industrial preservative and the active ingredient in many dandruff shampoos, is shown to be ineffective for psoriasis in various combinations of isopropyl myristate and other solvents. Microscopic examination of early Skin-Cap showed none of the zinc pyrithione particulate later found in the cans after questions arose about the ingredients. Tests by the FDA after the zinc was added found that some cans and shampoo contained as little as 13% of the listed quantity. At this point, the FDA sent the first warning letter.
Suspicion that the product contained a potent steroid was repeatedly dismissed, most notably by a Dr Charles Crutchfield III who was testing Skin-Cap for efficacy with funding and support from Cheminova. Crutchfield claimed to have tested for different steroids, and found none. Reports from Spain and other countries about the triamcinilone acetonide steroid were compelling. Tests were conducted by the Mayo Clinic, and later by Glaxo and the FDA, which found clobetasol propionate, a class 1 superpotent steroid and other unidentified compounds. At this point, the product was banned and a warning was widely published. The NPF's 800 number was listed as a resource, and they received thousands of calls from concerned users of the product. Many were upset that the product was banned, and they directed that anger at the NPF, the FDA, and cited wild conspiracies involving Glaxo and the whole pharmaceutical industry. Grassroots campaigns of angry letters were directed.at everyone involved except the sole source of the problem, namely Cheminova. Cheminova has yet to admit to any steroid component in the Skin-Cap products, and in spite of the ban, they continue to illegally market over the net and ship directly from Madrid.
Send in the Clones
Before Skin-Cap was banned, several opportunists attempted to clone the product using the ingredients passed on from Cheminova through Andy Kanter, namely zinc pyryitione, isopropyl myristate, sodium lauryl sulfate, and alcohol..They marketed the product using testimonials from Skin-Cap customers, replacing Skin-Cap with their own brand name, claiming it was just the same. In the wake of the ban, these companies and more began recruiting pharmacies to compound their clone mixture with superpotent steroids. They currently market these products despite FDA and pharmacy association ethical guidelines against the promtion of compounded products. The practice of compounding is a legitimate way for doctors to tailor custom medications for their patients, but the marketing of a product created this way is an unethical end-run around product safety testing. Regulation of pharmacies is handled differently by each state but many have declared the practice illegal.
Formula for Compounding
Many people would like to have available the quick clearing of a topical steroid spray, for use when a flare occurs, or perhaps before an important public appearance. These can be safely used short term, if one is aware of the dangers of overuse and the precautions that need to be taken for eye protection to prevent glaucoma. The legitimate and inexpensive way to experiment with this would be to either use an existing prescription steroid spray such as temovate or kenalog, a topical steroid foam like Olux, or to have a dermatologist prescribe a compounded medication. Only Cheminova knows the exact Skin-Cap ingredients for any batch, but there have been educated guesses. A reportedly accurate lab analysis of a popular knockoff may be a better starting point. For 100g mix::
2 oz isopropyl myristate (increases penetration of the steroid) 2 oz ethanol (SD40B) (another clone uses 2/3 alcohol) 300 mg undecylenic acid (no known benefit for psoriasis) 250 mg zinc pyrithione (irritant - no good evidence for psoriasis) 100 mg sodium lauryl sulfate (watch out, it's an irritant) 50 mg clobetasol propionate (or equivalent superpotent corticsteroid)
Isopropyl myristate is fairly tame, being the top ingredient in Neutrogena "Body Oil", but its penetration of the skin is most likely what makes it an effective vehicle for the steroid. Undecylenic acid is an antifungal agent, the active ingredient in Desenex athlete's foot products. Sodium lauryl sulfate is a common surfactant used in cleaning products.
July 2003 update: A recent clinical trial has been conducted to specifically test for any benefit from the addition of zinc pyrithione to a potent topical steroid treatment. The tests showed that there was no significant improvement from the added zinc. In fact, areas treated with zinc showed slightly less improvement. This shows that the marketing of compounded Skin-Cap "zinc clones" with steroids is not only unethical and based on a huge hoax, but apparently of less benefit than a steroid formula alone.
Patents filed After the Fact
On Oct 26 1999, Dermalogix was granted a patent for their formulation. It details their preferred formulations and confirms the above recipe for private compounding. It refers to Cheminova and the banned Skin-Cap, from which they reverse engineered their formula. It's amazing the patent was granted at all, and it would undoubtedly not hold up to a challenge if they attempted to enforce their patent claim by demanding royalties or preventing the sale or use of any other Skin-Cap "clones". A printable public domain image of the patent may be shared freely. (Adobe Acrobat Reader is needed to view the .pdf document.)
The Dermalogix patent states that for about 40% of all patients with any of various skin conditions they claim to treat, "zinc pyrithione is inadequate to alleviate the symptoms". This is counter to their advertising claims for DermaZinc without clobetasol propionate. Note that psoriasis is generally regarded as much less responsive to ZnP than fungal skin conditions such as dandruff. They claim that "there are strong indications that fungus and/or mold is present in a number of skin conditions including, but not limited to, psoriasis." This is misleading, since a variety of microbes are present in all conditions of skin (thus the value antiseptics whenever there is a break in the skin.)
On Nov 23 1999, Dr. William Rosenberg was granted patent # 5,990,100 for the use of isopropyl myristate in treating psoriasis. Similar to claims in his previous patent # 5,886,038 which covers its use as an active agent, this one claims sole rights to its use as a carrier for any antipsoriatic agent. Again, this formula appears to have been reverse engineered from the banned Skin-Cap product, and the patent is broad enough to cover existing products (such as Cutivate, Psorcon and Nutracort.) The formula for generic clobetasol propionate emollient cream also contains isopropyl myristate. Rosenberg is well known for his microorganism theories of psoriasis. Promotional claims for Andy Kanter's At Last clone are based on unpublished tests of his product by Rosenberg. Note that the patent is assigned to Panda Pharmaceuticals, in Memphis, whose only known product is At Last spray. The formulas in the patent are presumably for the same product, and Kanter likely has an interest in the patent.
In August 2000, The maker of Prosanol (based in California, not Sweden) was granted Patent 6,096,326 for a topical product. The marketed product lists isopropyl myristate and various waxlike ingredients, but the patent emphasizes purcellin oil with an embodiment of clobetasol propionate. Purcellin oil is the major component of some species of birds' preening gland. It's even available in pet stores as Bird Bath spray. (For the curious, emus don't produce purcellin oil.)
It should be very interesting to see what other patents will be appearing, and what attempts will be made to enforce them. None of these patents are likely to withstand scrutiny, since the basic patent requirement that a process be novel and not obvious is based on complete disclosure of known prior art. It would seem that a patent for marketing purposes is becoming easy to obtain.
Zinc Sprays Mass Marketed as Psoriasis Treatments
Starting in 1999, there have been several agressive marketing campaigns for topical zinc products such as Skin-Plaque, Skin-Zinc, SkinZinc, Acadia Skin Care, and others. These appear to sprout up around the Scarborough, Maine area. That is coincidentally where DermaZinc is produced. Questions to a telemarketer for the Skin-Zinc product gave hints that Jeff Kral and selfworx.com (whois) is the marketing company behind the SkinZinc campaign. The ads have appeared in USA Today, many newspapers, radio spots, and now half hour infomercials in many cities. They never list the ingredients or price, but they often make claims that the product is patented and FDA approved. This is a deception, because no such products are allowed to claim FDA approval, and makers of topical zinc pyrithione products are in fact specifically banned from making psoriasis treatment claims. [See April 9, 2003 FDA Skin-Zinc Warning Letter.] It is presumed that they are without any added steroids, but the promoters are clearly operating outside ethical boundaries and it's hard to guess how far they are willing to go to make a buck. Note that SkinZinc is marketed using the same before/after photos as DermaZinc with clobetasol. The SkinZinc makers state the ingredients as 0.25% Zinc Pyrithione, Water, Glycerine, Propylene Glycol, with added willowherb, aloe, and quaternium 15. Many people have reported returning these zinc products as ineffective, with almost no reports of success (except by shills) either publicly or privately. The $15 shipping fee isn't refundable, and Selfworx suggests insuring and package-tracking any returned products, or they will not be responsible for providing a refund.
Some collected References and Links:
Public reports about Skin-Cap by the author of this FAQ
Ongoing Usenet Discussions about Skin-Cap or Cheminova
FDA: Warning and ban on Blue-Cap Spray. Steroids found. 7/11/2000
Skin-Cap Class Action Suit upheld by Alabama Supreme Court 6/30/2000
Health Canada: Warning not to use Skin-Cap Spray 3/17/2000
Clinical testing shows that zinc pyrithione does NOT enhance steroid effectiveness for treating psoriasis 7/2003
National Psoriasis Foundation reports and press releases
The NPF's investigation into Skin-Cap 4/19/2000 (archived)
NPF: Skin-Cap pulled from Canadian market again 3/23/2000 (archived)
NPF: An update on Skin Cap 5/12/99 (archived)
NPF Forum report: Testing of Skin-Cap vs ZnP vs Cobetasol 7/99 (publication not online)
NPF estimates that response to Skin-Cap issues cost members over $45,000 in 97-98 (archived)
NPF update on earlier reports from the Netherlands 9/19/97 (archived)
NPF Skin-Cap Q&A 8/30/97 (archived)
NPF Press Release on the Skin-Cap ban 8/8/97 (archived)
Dermatologists debate Skin-Cap
Dermatology Online Journal - Editorials 12/97
Skin-Cap history in Spain (no Zinc Pyrithione detected in early cans)
Skin-Cap: What Have We Learned ...?
Documented adverse reaction - pustular flare and liver toxicity
Crutchfield denies responsibility for his inaccurate reports
(He claims "no reason to doubt" Cheminova, despite intense public concern.)
Crutchfield responds to journal editors' criticisms with accusations of his own.
March 2001 discussion of Advances in Psoriasis treatment discusses topical steroids
Misinformation and Propaganda at the Save-Skin-Cap page
Cheminova 3/10/98 Response to FDA
User input to SaveSkinCap shows up as Swisspharma testimonials
Swisspharma adds confusion to the controversy as they continue selling Skin-Cap
USA Today - article on Skin-Cap and BlueCap 7/23/99
A public response from Cheminova through one of its distributors
Banned almost everywhere else, now heavily marketed in Russia
World Health Organization Alerts and UK vectoring of impure alcohol hoax
Health Canada - Skin Cap Warning 9/13/97
Mayo Clinic Lab Analysis with mass spectrum comparison 7/22/98
Mayo Clinic Editorial 8/20/97
Crutchfield again, testing clones this time 6/19/98
Click and Print your own prescriptions online for the opportunistic knockoffs
Anasilpiel, a possible precursor Corticosteroid/Antibiotic product - public response
History of Skin-Cap in Denmark and Holland 1/98
Ezcema list comments, Asthma rebound, FDA reports 9/97
Article on Lawsuits from Skin & Allergy News 4/98 (free Medscape reg required)
Skin-Cap Timeline (not entirely accurate) Fall 1997
Trademark lawsuit filing by Cheminova against DermaCap, an early clone 7/24/97
CBC - Canadian Broadcast Corp MarketWatch video segment (protesting the Canadian ban) 12/8/97
AAD - American Academy of Dermatology joins in with a press release 8/12/97
Tests and recall in the UK 9/4/97
Dermatology Times of Canada report on Crutchfield's AAD conference "Miracle" April Fools Day, '97
Dermatology in Practice - article on Skin Cap Controversy vol 6, no 2 March/April '98
Italian ban on the product 12/2/97 (in italian of course)
Health Canada warns consumers of clobetasol propionate in Miralex. Nov 18, '99Info at the US FDA site:
FDA warning letter to Jeffey Kral and Selfworx about Skin Zinc April 9, 2003
FDA warning letter to SkinTech2000 regarding Blue Cap April 10, 2001
FDA Bans and warnings on Blue Cap May-Sept 2000
FDA 1998 Screening for Corticosteroids in Pharmaceutical Products by HPLC
FDA 1998 Detection of Clobetasol Propionate as an Undeclared Steroid in ZnP Formulations
FDA 3/9/98 Import bulletin: Cheminova dealing banned NSAID - street name "Bute"
FDA 2/20/98 Import alert
FDA 12/17/97 Enforcement report - Cheminova America "recall" of 20,000 units.
FDA 12/97 Consumer Update warning
FDA 8/8/97 MedWatch press release - Skin-Cap warning
FDA 8/8/97 HHS News press release - Skin-CAP warning
FDA search for "cheminova OR skin-cap"
FDA regulation of psoriasis product ingredients and labeling
With the Acrobat Reader plugin, you can view these .pdf documents:
FDA warning letter 3/4/98 to Cheminova in Madrid (pdf)
FDA warning letter 6/18/97 to Cheminova America - Skin-Cap Shampoo (pdf)
FDA warning letter 12/11/96 to Cheminova America - Epigen (pdf)
FDA warning letter 6/18/97 to Nova Medical - Skin-Cap Spray lab tests (pdf)
So what! Where can I get the stuff?
Skin-Cap promoters (Banned, so all are apparently shipping directly from Spain)
FDA rules ban making psoriasis treatment claims for zinc, considered ineffective unless compounded with a prescription steroid which is effective on its own. Most are compounding with clobetasol propionate, one the most potent known synthetic steroids. Those who do promote specific compounded drugs are in violation of federal and state pharmacy laws and the pharmacy associations' code of ethics. However, several compounding pharmacies have successfully sued the FDA, effectively protecting the constitutional rights of promoters to make misleading claims for compounded drugs. The clones continue to have a field day while the FDA regroups to come up with legislation that might fulfill their charter to protect the public health. (Perhaps by broadly requiring all promoters to declare potential health risks, rather than only claiming potential benefits plus some empty disclaimer.)
Also at this site:
The Psoriasis Hall of PShame
The Skin Page for self help research links
Psoriasis Support Newsgroup Introduction and Posting Guide
Please post any new facts regarding this issue to the global psoriasis newsgroup.
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