CollaGenex Reports Phase III Data Evaluating Oracea as a Treatment for Rosacea

CollaGenex Pharmaceuticals has announced positive results from two Phase III, double-blinded, placebo-controlled clinical trials designed to evaluate the safety and efficacy of Oracea for the treatment of rosacea, a common but little-known disorder of the facial skin.

The trials enrolled a total of 537 patients in 28 centers across the U.S. Patients in the study were administered either Oracea or placebo once a day for 16 weeks. Both studies achieved their primary endpoint by demonstrating a greater reduction in inflammatory lesion count over base-line for the Oracea-treated patients compared to the placebo controls. The differences were clinically and statistically highly significant. In the studies, patients receiving Oracea experienced a 61 percent and 46 percent mean reduction in inflammatory lesions compared to 29 percent and 20 percent, respectively, in patients receiving placebo.

The data from the trials will be presented at the American Academy of Dermatology in Chicago in July.