Ceragenix begins enrollment in pediatric clinical study of EpiCeram in treatment of eczema

By Lisa Kerner

Charlotte, N.C., Aug. 14 - Ceragenix Pharmaceuticals, Inc. started enrolling patients in a multicenter pediatric clinical study to assess the efficacy of its topical cream EpiCeram compared to Cutivate, a commonly prescribed mid-strength steroid, in patients with moderate-to-severe atopic dermatitis (eczema).

In the study of 90 children, ages six months to 18 years, half will receive treatment with EpiCeram and half will receive treatment with the steroid for a four-week period.

Ceragenix said it will measure trans-epidermal water loss to determine whether EpiCeram can be as effective as a mid-strength steroid in restoring a more normal skin barrier. It will also compare EpiCeram's effectiveness in treating itching and inflammation.

Study results are expected in the fourth quarter of 2006.

The Food and Drug Administration granted marketing approval to EpiCeram to treat symptoms of various dermatoses including eczema, irritant contact dermatitis, radiation dermatitis and other dry skin conditions by maintaining a moist wound and skin environment.

"If EpiCeram proves to be as efficacious as a mid-strength steroid, we believe it will be well received by pediatricians and dermatologists," chairman and chief executive officer Steven Porter said in the news release.

"Topical steroids and immunosuppressants represent the majority of the estimated $1 billion market for treating eczema in the United States."

Since EpiCeram is neither a steroid nor an immunosuppressant, it should eliminate certain concerns associated with these treatments, including the recent Black Box warning the FDA now requires on immunosuppressants, officials said.

Ceragenix said it is in discussions to commercialize EpiCeram in partnership with a large pharmaceutical company experienced in marketing dermatology products.

Denver-based Ceragenix discovers, develops and commercializes novel anti-infective drugs.

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