Clinical Trials Resource Center

Cutaneous Lupus Erythematosus

August 27, 2007

Collagenex announced positive results from a phase II trial of Col-118 for the treatment of erythema. This double-blinded, placebo-controlled trial enrolled 110 subjects who were treated with one of three doses of Col-118 or placebo. Subjects applied Col-118 or placebo daily throughout the 28-day treatment period. On days 1, 14 and 28, each subject applied Col-118 once in the investigator's office and was assessed at set intervals during the day using various scores, including Clinical Erythema Assessment (CEA). The primary endpoint was a reduction in average CEA scores across all visits compared to baseline. This primary endpoint was met and demonstrated a strong dose-dependent relationship. At day 28, the average CEA reduction in the Col-118 high dose arm was 1.6 at peak efficacy compared to an average peak reduction in the placebo arm of 0.7, (p less than 0.001). At day 28 the average CEA reduction in the mild dose Col-118 arm was 1.3 (p less than 0.05), and the average reduction in CEA in subjects in the low dose Col-118 arm was 1.0 (p=0.2). Based on the results, Collagenex plans to commence phase III trials in Q1 of 2008.

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