(11f) Reply to David Boyce
Published Web Locationhttps://doi.org/10.5070/D35nv6t82s
(11f) Reply by Charles Crutchfield MD
|Dear Editor, Dermatology Online Journal:
We were shocked and very disappointed to recently learn of the presence of the potent corticosteroid, clobetasol propionate, in Skin-Cap Spray. Moreover, we are deeply disturbed at the shameless disregard for patient safety displayed by the makers of Skin-Cap.
Prior to initiating the our clinical research study, Skin-Cap's manufacturer, Cheminova International, S.A. and Cheminova America Corporation assured us that the product contained absolutely no corticosteroids. We had no reason, at that time, to doubt those assurances.
In May of 1997, due to several anecdotal reports from other countries that Skin Cap was found to contain corticosteroids (specifically triamcinalone), we again asked the manufacturer about the presence of any steroids in Skin Cap Spray. The manufacturer refused to answer our questions. At that point we terminated our informal relationship with the company and truncated the research study. We then had skin cap specifically for the presence of triamcinalone and hydrocortisone, and both assays were negative. Unfortunately, at that time, we did not suspect nor test it specifically for clobetasol. To detect a steroid in a solution, as we later learned, one must look specifically for that exact steroid, not just any member of the family, or risk missing it's detection, which turned out to be the case in our efforts.
Recently, our colleagues at the Mayo Clinic, Glaxo Labs and other independent labs (associated with the FDA), used the most sophisticated and appropriate analytical tests to confirm the presence clobetasol propionate in Skin Cap. In light of this finding they also were able to detect the same ingredients in the cans provided to us by Cheminova for research purposes. These findings were forwarded to the FDA for the appropriate actions.
We applaud the outstanding efforts of the FDA, American Academy of Dermatology, Mayo Clinic, and Glaxo Labs relating to this situation.
We, like everyone else, were repeatedly mislead by Cheminova America Corp. and Cheminova International, S.A. in that they intentionally misrepresented to us that Skin Cap contained no steroids.
In order to better evaluate this preparation and to determine the potential side effects and complications of this product, we will complete our truncated clinical research study and submit the results for publication.
We encourage all physicians to arrange an appropriate taper for any patients known to be using this product.
Charles Crutchfield III MMB, MD
Eric Lewis MD, PhD
Brian Zelickson MD