![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » CERAGENIX BEGINS PEDIATRIC TRIAL OF EPICERAM
CERAGENIX BEGINS PEDIATRIC TRIAL OF EPICERAM
Ceragenix Pharmaceuticals has begun enrolling patients in a multicenter pediatric clinical study designed to assess the efficacy of EpiCeram compared with Cutivate, a commonly prescribed mid-strength steroid, in patients with moderate-to-severe atopic dermatitis, or eczema. The company expects to report results of this trial in the fourth quarter of 2006.
The study will consist of 90 children between the ages of 6 months and 18 years of age. Half of the children will receive treatment with EpiCeram, and half 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 normal skin barrier, as measured by trans-epidermal water loss, and treating the symptoms associated with eczema.
Ceragenix received approval from the FDA in April to market prescription-only 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.
KEYWORDS Drug Pipeline Alert
Upcoming Events
-
21Oct