CollaGenex Pharmaceuticals Reports Results of Col-118 Trial

CollaGenex Pharmaceuticals announced results of a Phase II dose-finding study designed to evaluate the safety and efficacy of Col-118 for the treatment of erythema.

Erythema is a bright skin redness associated with erythematous rosacea and other dermatological conditions. According to CollaGenex, Col-118 is a topical formulation that incorporates a compound that could potentially reduce erythema by constricting enlarged blood vessels in facial tissue.

The double-blinded, placebo-controlled, Phase II study enrolled 110 patients at six centers. The study had four arms, and patients were treated with one of three concentrations of Col-118 or a vehicle control.

The treatment duration involved patients applying Col-118 daily for 28 days, with a 28-day follow-up. On days one, 14 and 28, each patient applied Col-118 once in the investigator’s office and was assessed at set intervals during the day.

The study successfully demonstrated a strong dose response relationship and achieved its primary endpoint, the company said. The average reductions in CEA in patients who had received the mid and the high doses of Col-118 were substantially greater across all visits than that of patients receiving the vehicle control, the company said.