Barrier Therapeutics released the results of two Phase III trials for its drug Sebazole, indicating the drug's effectiveness in the treatment of facial seborrheic dermatitis. Seborrheic dermatitis is a chronic inflammatory skin condition affecting about 3% of the United States adult population. Currently-approved prescription therapies require twice-daily application and must be used for four weeks or until remission.
Results from the 50-center 900 patient trial determined that Sebazole is effective in the treatment of facial seborrheic dermatitis with a once-daily treatment regimen of only two weeks. The blinded, placebo-controlled Phase III trials compared the safety and efficacy of the following treatment arms: Sebazole (Barrier's proprietary gel containing 2% ketoconazole, an antifungal); Barrier's gel containing 0.05% desonide, a steroid; Seboride (Barrier's gel containing a combination of 2% ketoconazole and 0.05% desonide); and a placebo consisting of Barrier's gel with no active ingredient. Patients were treated once daily for a period of only two weeks. The primary efficacy endpoint was the proportion of patients that were effectively treated ("cleared" or "almost cleared") at Day 28, which was two weeks following the end of treatment.
Sebazole emerged as the best treatment from among the treatment arms. In both studies. Sebazole achieved statistical significance in the primary efficacy endpoint against the placebo gel (U.S. study: p=0.002 and EU study: p=0.021). Furthermore. Sebazole was found to be comparable to the gel containing desonide and to Seboride, the combination of ketoconazole with desonide, indicating that adding a steroid to the topical regimen does not provide additional benefit in this patient population at two weeks post treatment. Good symptom suppression was maintained with Sebazole for the two weeks following the end of treatment.
COPYRIGHT 2004 Journal of Drugs in Dermatology
COPYRIGHT 2004 Gale Group
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