CollaGenex drug meets trial goal

The drug, Col-118, is a topical formulation that incorporates a compound believed to reduce erythema, a bright skin redness, by constricting enlarged blood vessels in facial tissue. The Phase II clinical study demonstrated a highly statistically significant dose-response relationship of Col-118 in the reduction of erythema, with a side effect profile similar to the vehicle control.

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 primary clinical endpoint of this study was a reduction in average clinical erythema assessment (CEA) score across all visits compared to baseline. The CEA is a five-point scale ranging from zero to four, with grade zero described as clear skin with no signs of erythema and grade 4 described as severe erythema characterized by a fiery redness. At baseline, all patients had moderate to severe erythema and scored either grade three or four.

Klaus Theobald, chief medical officer of CollaGenex, said, “At peak efficacy, 38% of patients in the high dose group had CEA scores of zero or one, indicating that they were clear or near clear of erythema. Clinically, these results are very meaningful and, with this data in hand, we expect to begin our phase III testing in the first quarter of 2008.”