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news.CollaGenex Pharmaceuticals' COL-3 has achieved positive results in a phase II clinical study in rosacea, significantly reducing inflammatory lesions compared to placebo.
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The double-blinded, placebo-controlled phase II clinical study was designed to evaluate the safety and efficacy of COL-3 for the treatment of rosacea, an inflammatory skin condition.
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% reduction in lesion counts compared to an increase of 12% 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 towards improvement. No serious adverse events were reported.
“While this was a relatively small study, the magnitude of the drug effect is extraordinary,” said Dr Klaus Theobald, senior vice president and chief medical officer of CollaGenex. “Compared to other therapies, there was a rapid onset of the treatment benefit, which is very encouraging for patients seeking to quickly resolve the unattractive manifestations of this disease.”
CollaGenex also revealed that it is planning to initiate a proof-of-principle phase II study of COL-3 in acne shortly.