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Barrier Therapeutics reported results from a phase III trial investigating Zimycan, a topical antifungal ointment for the treatment of Candida-associated diaper dermatitis. Results showed that Zimycan achieved statistical significance versus vehicle ointment for all endpoints. Data showed that the average reduction in the signs and symptoms score, was 72% with Zimycan versus 25% with the vehicle ointment. More than twice the subjects treated with Zimycan reached the primary endpoint, overall cure at day 14, as compared with vehicle. The double-blind, vehicle-controlled study enrolled 236 infants at 20 sites in the U.S. and Latin America. Subjects were given Zimycan or vehicle for seven days. The study will form the basis of the filing of an amendment to Barrier's pending NDA.
Novartis reported positive results from a late phase trial investigating Elidel (pimecrolimus), a previously approved ascomycin derivative for the treatment of eczema in infants. Results indicated that more than twice the subjects treated with Elidel (54.4%) were clear or almost clear of eczema compared to those treated with inactive cream (23.8%). In addition, subjects in the vehicle groups who transferred to the treatment group achieved similar disease control. Less than 5% of subjects experienced site reactions or skin infections and these events were similar in both the treatment and placebo groups. The randomized, double blind, vehicle controlled study enrolled 186 infants aged 3 to 23 months. The initial double blind portion of the trial lasted for six weeks followed by a 20-week open labeled stage.