For further information:|
August 8, 1997|
For Immediate Release
OTC psoriasis drug potentially harmful,
Skin-Cap, a popular over-the-counter (OTC) drug used for psoriasis, may contain an undisclosed superpotent prescription medication which can cause serious side effects if used unknowingly. The National Psoriasis Foundation (NPF) is urging anyone using this product to consult with their dermatologist.
FDA analysis has shown this product contains prescription levels of a superpotent topical steroid, clobetasol propionate, and the agency is warning people about the product. Mass spectrometric analyses of Skin-Cap performed by investigators at the Mayo Clinic in Rochester, Minnesota, also suggest the presence of clobetasol propionate. In addition, tests performed by labs at Glaxo Dermatology, a division of pharmaceutical company Glaxo Wellcome Inc., found clobetasol propionate in Skin-Cap, and Glaxo confirmed those findings with an outside independent laboratory.
Anyone using Skin-Cap should immediately discuss these findings with their dermatologist. When used as prescribed by a physician, clobetasol propionate can be a safe and highly effective treatment for psoriasis. However, side effects from long-term use of potent topical steroids can include stretch marks, thinning skin, and tiny dilated blood vessels. High doses, overuse or long-term use of potent topical steroids can cause very serious internal side effects.
Note: If you have psoriasis, you should not stop using any product containing topical steroids without the guidance of a dermatologist, because abrupt withdrawal from topical steroids can significantly worsen psoriasis, and cause the disease to flare.
Skin-Cap is manufactured by Cheminova International in Madrid, Spain. It has been available in the US through several distributors. Cheminova International claims that the active ingredient in Skin-Cap is zinc pyrithione (ZnP). ZnP is an active ingredient found in some dandruff shampoos, which have no history as effective psoriasis treatments. Cheminova has repeatedly denied the presence of corticosteroids in Skin-Cap, most recently in a letter to the NPF dated August 4.
ZnP has never been found to be safe or effective for the treatment of psoriasis. As an OTC product, Skin-Cap has never been approved by the FDA. ZnP is approved as an OTC active ingredient for seborrheic dermatitis and dandruff only.
Previous reports from several European countries that Skin-Cap contained topical steroids led the NPF to ask investigators to perform tests in the US. The Dutch Health Ministry ordered Skin-Cap banned from sale in late May because the product contained unreported steroids.
Psoriasis is a noncontagious, chronic skin disorder that can be painful and disabling. Over six million individuals in the US are affected by psoriasis. Uncontrolled, psoriasis can limit a personís ability to walk, bend, grasp, or sit. In rare instances, people can die from complications of psoriasis.
Psoriasis is characterized by inflamed, red, scaly lesions caused when affected skin cells reproduce six times faster than normal skin cells. Approximately 10% of people with psoriasis also develop a form of arthritis (psoriatic arthritis). There is currently no known cure for psoriasis, which is believed to be an autoimmune disease like rheumatoid arthritis.
The NPF is a lay, nonprofit health organization with a mission to provide information and support to people with psoriasis. Through public education, the NPF hopes to stimulate research to find a cure for the men, women, and children who suffer from this disease.
For more information on all treatments for psoriasis, call NPF at
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