The study will consist of 90 children between the ages of six months and 18 years of age. In the study, 45 children will receive treatment with EpiCeram and 45 will receive treatment with the steroid for a four-week period. The objective of the study is to determine whether Epiceram can be as effective as a mid-strength steroid in both restoring a more normal skin barrier (as measured by trans-epidermal water loss) and treating the symptoms associated with atopic dermatitis (eczema).
Ceragenix said that it expects to report results from this trial in the fourth quarter of 2006.
EpiCeram, a new prescription-only topical cream, is based on the Barrier Repair Technology, which was licensed by Ceragenix from the University of California. EpiCeram is a non-steroidal treatment for dry skin conditions, consisting of a proprietary formulation of ceramide, cholesterol and free fatty acids in a specific optimized ratio that helps restore a healthy skin barrier.
In April 2006, Ceragenix received clearance from the FDA to market EpiCeram to improve dry skin conditions and to relieve and manage the burning and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis, and other dry skin conditions by maintaining a moist wound and skin environment.