In patients with moderate to severe acne vulgaris (AV), treatment with FMX101 4% topical minocycline foam is well tolerated and effective for reducing the number of inflammatory lesions. This is according to a randomized trial published in the Journal of the American Academy of Dermatology.
Patients who presented with 20 to 50 inflammatory lesions, 25 to 100 noninflammatory lesions, ≤2 nodules on the face, and an Investigator’s Global Assessment score of grade 3 or grade 4 AV were enrolled. Minocycline, a semisynthetic, second-generation tetracycline, was developed into a topical foam vehicle and was administered to a random sample of patients with moderate to severe AV (n=738). Another group of patients with AV were randomly assigned to foam vehicle control (n=750). Treatment and foam vehicle control were applied once per day for 12 weeks.
Safety and efficacy assessments were performed at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment. The absolute change in the number of inflammatory lesions from baseline to week 12 comprised the primary efficacy endpoint.
Treatment with FMX101 4% was associated with a significantly greater reduction in the number of inflammatory lesions from baseline to 12-week follow-up compared with vehicle control (−16.93 vs −13.40, respectively; least-squares mean difference, 3.65; 95% CI, 2.46-4.83; P <.0001). A significantly greater number of patients in the FMX101 4% group achieved an Investigator’s Global Assessment score of clear or almost clear with a ≥2-grade improvement from baseline to week 12 (30.8% vs 19.6%; risk ratio, 1.58; 95% CI, 1.32-1.88; P <.0001).
A similar proportion of treatment-emergent adverse events were reported in the active therapy and control groups (26.2% vs 24.5%, respectively). Almost all the treatment-emergent adverse events reported during the 12-week period were considered mild to moderate in severity and were transient in nature. Treatment-related adverse events were 3.8% in the FMX101 4% group and 4.0% in the control group. The FMX101 4% and control groups reported hyperpigmentation in 14.4% and 17.3% of participants, respectively.
The lack of patients with mild AV represents a limitation of the study.
Although the researchers believe minocycline presents a lower risk for resistance compared with antibiotics, they suggest that “additional studies are needed to fully characterize the antibiotic resistance potential of topical minocycline.”
The authors report research funding from Foamix Pharmaceuticals, Inc.
Raoof TJ, Hooper D, Moore A, et al. Efficacy and safety of a novel topical minocycline foam for the treatment of moderate-to-severe acne vulgaris: A Phase 3 Study [published online June 1, 2019]. J Am Acad Dermatol. doi:10.1016/j.jaad.2019.05.078