CollaGenex Reports Positive Outcome of Study Evaluating COL-3
CollaGenex Pharmaceuticals has announced the results of a double-blinded, placebo-controlled Phase II clinical study designed to evaluate the safety and efficacy of COL-3 for the treatment of rosacea.
Col-3 is a second-generation IMPACs compound that has demonstrated a range of potent anti-inflammatory activities. This was a small, Phase II, proof-of-principle study that enrolled 13 patients who received either COL-3 or a placebo for 28 days. Patients were evaluated at baseline and at Days 14, 28 and 42.
Inflammatory lesion counts and assessments of erythema (redness) and overall clinical disease severity were obtained at each of these time points. At all time points during the course of the study, patients receiving COL-3 had significantly fewer inflammatory lesions than those on placebo. At Day 42, patients treated with COL-3 experienced a 69 percent reduction in lesion counts compared to an increase of 12 percent in the placebo group.
A treatment benefit was also apparent in the overall clinical severity score and less pronounced in the assessment of erythema, which trended toward improvement. No serious adverse events were reported.