Phase II study of incyclinide for treatment of acne

Journal of Drugs in Dermatology, May, 2007 by Marissa Heller

CollaGenex Pharmaceuticals, Inc recently announced positive results from a phase II dose-finding study of the safety and therapeutic range of incyclinide for the treatment of acne. The phase II study was a double-blind, placebo-controlled trial of 302 patients with acne at a total of 27 centers. Patients were divided into 4 arms of the study and treated with a 20-mg incylinide capsule, a 10-mg incyclinide capsule, a 5-mg incyclinide capsule, or a placebo capsule. All patients took their capsules once daily for 12 weeks. Patients were then assessed at baseline, weeks 3, 6, 9, 12, and 16 (after the final capsule).

Results of the study indicated that the minimum effective dose of incyclinide for treatment of acne was 10 mg per day and that greater efficacy was demonstrated at 20 mg per day. Incyclinide was well-tolerated in all groups, and its safety profile was similar to that of placebo.

CollaGenex plans to engage in further studies at the end of this year to investigate the maximum effective dose of this medication. In addition, phase III clinical trials are planned for the first quarter of 2008.