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Barrier Therapeutics reported positive results from a confirmatory phase III trial for Sebazole, a topical gel formulation of 2.0 ketoconazole for the treatment of seborrheic dermatitis. The double blind, vehicle-controlled, pivotal study enrolled 459 subjects at 24 sites across the U.S. Results demonstrated that 25.8% (59/229) of Sebazole treated subjects reached the primary endpoint, compared with 13.9% (32/230) of subjects treated with vehicle alone. The primary efficacy endpoint was the proportion of subjects who are effectively treated at day 28, defined as a reduction in the signs and symptom scores for redness and scaling to none or mild, as well as an investigator's global assessment of "completely cleared" or "almost cleared". The mean change from baseline for scaling showed a statistically significant improvement with Sebazole compared to vehicle alone. Another secondary efficacy endpoint, redness and itching, showed improved results compared to the vehicle alone, but were not statistically significant. There were no treatment related serious adverse events and non-serious drug related adverse events were similar in both groups. Based on the drugs complete phase III results the company plans to file a New Drug Application (NDA) for Sebazole by mid-2005.
Barrier Therapeutics reported positive results from two-phase III trials investigating Sebazole, a 2% ketoconazole antifungal for the treatment of seborrheic dermatitis. Results showed that Sebazole was effective in the treatment of facial seborrheic dermatitis with a treatment regimen of two weeks. Sebazole achieved statistical significance compared with the placebo gel and was found to be comparable to the gel containing desonide and to Seboride. Both blinded, placebo controlled trials compared the safety and efficacy of Sebazole, a 0.05% desonide, Seboride (2% ketoconazole and 0.05% desonide) and a placebo gel. The studies enrolled over 900 subjects at 50 sites in the U.S. and Europe. The primary endpoint was the proportion of subjects effectively treated at Day 28.