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Foamix announces enrollment complete in trials of minocycline foam for acne
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Foamix Pharmaceuticals Ltd. announced that it has completed enrollment in two phase 3 clinical trials to measure the efficacy and safety of FMX101, a topical 4% minocycline foam, for treating moderate-to-severe acne.
The phase 3 programs include simultaneous multi-center trials, each with a target enrollment of 450 patients with moderate-to-severe acne, with a total of 961 patients enrolled between the two trials, according to a press release.
In the initial 12-week double-blind phase, patients were randomized in a 2:1 bases to either received FMX101 or a foam vehicle, according to the release. The absolute change from baseline in inflammatory lesion counts in each treatment group and portion of patients achieving an Investigator’s Global Assessment score of “clear” or “almost clear” with at least a 2-grade improvement from baseline, all at week 12, are the two co-primary efficacy endpoints of the trials.
Foamix announced it expects to report top-line results of the trials in the first half of 2017.
Reference: www.foamixpharma.com