Ceragenix approved to begin study of EpiCeram, Cutivate in pediatric eczema

By Lisa Kerner

Charlotte, N.C., June 27 - Ceragenix Pharmaceuticals, Inc. said it has received Institutional Review Board (IRB) approval to begin a multicenter study comparing the use of Ceragenix' EpiCeram, a non-steroidal skin barrier cream, to Cutivate, a commonly used mid-strength topical steroid, in 90 children (six months to 18 years) with moderate-to-severe atopic dermatitis (eczema).

The company expects to begin the study in July at private dermatology offices in California and New Jersey.

Both EpiCeram and Cutivate will be applied twice daily to affected skin areas. Outcome measurements will include EASI, Scorard and Ossad scores as well as trans-epidermal water loss, an indicator of the skin barrier's integrity.

"The market for prescription products used to treat eczema is close to $1 billion in the United States," chairman and chief executive officer Steven Porter said in a company news release.

"We are optimistic that this study will demonstrate at least comparable efficacy of EpiCeram to a mid-strength steroid, and thereby offer patients and their families an effective way to obtain symptomatic relief without the risks associated with topical steroid use."

Denver-based Ceragenix develops and commercializes novel anti-infective drugs based on its proprietary class of compounds, Ceragenins.

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