New Foam Treatment Effective for Moderate to Severe Acne
A recent study found that a topical minocycline foam, FMX 101 4%, was safe and effective for the treatment of moderate to severe acne.
The 2 identical phase 3 studies included a total of 961 participants with moderate to severe acne vulgaris. Participants were randomized to once-daily FMX 101 4% foam or vehicle for 12 weeks. Changes in inflammatory lesion count from baseline to week 12 and treatment success rate, defined as Investigator’s Global Assessment score of 0 or 1 (clear or almost clear), at week 12 were assessed as the primary endpoints.
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In both studies participants treated with FMX 101 4% foam experienced significantly greater reductions in inflammatory lesions compared with those treated with vehicle. Additionally, noninflammatory lesion count was significantly lower among participants treated with FMX 101 4% foam compared with vehicle. The pooled analyses of both studies showed statistical significance on both endpoints.
Skin-related adverse events were reported in less than 1% of participants who received FMX 101 4% foam.
“FMX101 4% topical minocycline foam appears to be a safe and efficacious treatment for moderate to severe acne,” the researchers concluded.
Gold LS, Dhawan S, Weiss J, Draelos ZD, Ellman, H, Stuart IA. A novel topical minocycline foam for the treatment of moderate-to-severe acne vulgaris: results of two randomized, double-blind, phase 3 studies [published online August 27, 2018]. J Am Acad Dermatol. doi:10.1016/j.jaad.2018.08.020