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Phase 3 Clinical Trial Initiated With Sebazole in Seborrheic Dermatitis
The Company expects to enroll approximately 440 patients at 22 centers across the United States. The double-blinded, placebo-controlled study compares once-a-day Sebazole(TM) treatment to placebo (the waterless gel formulation alone) over two weeks of therapy. The primary efficacy endpoint is the proportion of patients who are effectively treated at day 28, which is 14 days following the end of the treatment period. For the purpose of this clinical trial, "effectively treated" means that a patient is "cleared" or "almost cleared" of seborrheic dermatitis, as determined by the physician's observation. This primary efficacy endpoint is identical to that used in the Company's prior Phase III trials for seborrheic dermatitis, noted below.
In January 2004, Barrier reported the results of two Phase III clinical trials for the treatment of seborrheic dermatitis in which Sebazole(TM) achieved statistical significance in the primary efficacy endpoint against the placebo gel (U.S. study: p The current Phase III trial is being conducted in response to a request from the Food and Drug Administration (FDA) for a trial containing only two arms, Sebazole(TM) and placebo. It is expected to be completed by the end of 2004. The trial is subject to a Special Protocol Assessment, under which Barrier and the FDA have agreed on the design of the trial. The results of the study are expected to form the basis of a New Drug Application to the FDA.
Commenting on today's news, Geert Cauwenbergh, Ph.D., Chairman and Chief Executive Officer of Barrier said, "Seborrheic dermatitis can be a severe and chronic disease, making it difficult for some patients to control long-term. As a result, a treatment that would provide long lasting efficacy, and one which would require only one-fourth the number of applications as currently available treatments, could constitute a significant therapeutic advantage in terms of compliance."
Jonathan Weiss, M.D., Assistant Clinical Professor of Dermatology at Emory University in Atlanta, and a clinical investigator for Sebazole(TM), commented, "Seborrheic dermatitis is one of the most common skin conditions facing the dermatological community today. Although a great deal of work has already been done to better understand and address this disease, and while approved prescription therapies are available, most require twice-a-day application and lengthy treatment times. As a result, there is a real need for fast-acting and effective alternatives."
About Seborrheic Dermatitis
Seborrheic dermatitis is a skin inflammation characterized by a red, scaly, itchy rash primarily occurring on the face, scalp, hairline, eyebrows and trunk. The condition often recurs, thereby requiring re-treatment over time. Seborrheic dermatitis affects approximately 3% to 5% of the U.S. population. Barrier estimates that approximately 8.5 to 14.3 million people are affected. Current prescription therapies consist primarily of topical ketoconazole creams and topical steroids. These treatments typically require multiple applications per day over periods of up to four to six weeks to be effective.
Source: Barrier Therapeutics, Inc.