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Phase III Study Demonstrates Sebazole Is More Effective Than Seboride
The two blinded, placebo controlled Phase III trials enrolled more than 900 patients in approximately 50 centers in the United States and Europe. Each study compared the safety and efficacy of the following treatment arms: Sebazole (Barrier’s proprietary gel containing 2% of the antifungal known as ketoconazole); Barrier’s gel containing 0.05% of the steroid known as desonide; 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.
Although the studies were initially designed primarily for Seboride and were conducted following FDA regulations for combination product development, 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.
“When we began these trials, the expectation was that the combination product Seboride would have emerged as the best treatment,” said Geert Cauwenbergh, Ph.D., Chairman and Chief Executive Officer of Barrier Therapeutics. "The results determining that Sebazole is superior are a pleasant surprise and particularly interesting in that it is a non-steroid treatment, providing an additional safety benefit to patients. Furthermore, our proprietary formulation allows for Sebazole to achieve a therapeutic benefit within a two-week time frame with only a once-a-day dosing. This less onerous regimen, that also has a fast onset and is long-acting, is a key advantage when compared to treatments currently available.”
Additionally, in a cumulative irritation patch study in volunteers that was recently completed, Sebazole was approximately 5 times less irritating than a cream containing 2% ketoconazole, which is one of the most widely used products for this indication.
Barrier has scheduled a meeting with the U.S. Food and Drug Administration in February to discuss the findings of these two Phase III studies and to agree on next steps for Sebazole.
About Seborrheic Dermatitis
Seborrheic dermatitis is a chronic inflammatory skin condition characterized by a red, scaly, itchy rash primarily occurring on the face, scalp, hairline, eyebrows and trunk. The disease affects 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.
Source: Barrier Therapeutics, Inc.