Topical minocycline foam (FMX103) is a safe, effective, and well-tolerated treatment in patients with moderate to severe facial papulopustular rosacea, according to the results of a phase 2 randomized double-blind trial conducted at 18 study centers in Germany (ClinicalTrials.gov identifier: NCT02601963) and published in the American Journal of Clinical Dermatology.
Patients age ≥18 with moderate to severe rosacea that had been diagnosed
≥6 months earlier and who had ≥12 inflammatory facial lesions were randomly assigned in a 1:1:1 ratio to one of three treatment groups: 1.5% FMX103, 3% FMX103, or vehicle for 12 weeks. The primary study end point was absolute change in lesion count at week 12. Among other outcomes were ≥grade 2 Investigator’s Global Assessment (IGA) improvement, IGA “clear” or “almost clear” (IGA 0/1), clinical erythema, and safety/tolerability. Efficacy and safety were evaluated at 2, 4, 8, and 12 weeks, with a safety follow-up conducted at week 16.
A total of 232 participants were randomly assigned to treatment, with 213 completing the study. At week 12, a reduction in inflammatory lesion count was significantly greater with the 1.5% FMX103 and 3% FMX103 doses compared with vehicle treatment (21.1 and 19.1 vs 7.8, respectively; P <.001). Both doses of FMX103 were significantly better than vehicle for attaining ≥grade 2 IGA improvement (P <.05 with 3% FMX103 and P <.01 with 1.5% FMX103) and achieving “clear” or “almost clear” skin (P <.05 with 3% FMX103 and P <.01 with 1.5% FMX103) at 12 weeks.
Both FMX103 doses were generally safe and well tolerated. Overall, 4.7% of participants reported treatment-emergent adverse events, with all but one (eye discharge) considered dermal-related and resolved by the end of the study.
The researchers concluded that FMX103 is a safe and effective therapy for facial papulopustular rosacea and larger clinical trials are warranted.
Mrowietz U, Kedem TH, Keynan R, et al. A phase II, randomized, double-blind clinical study evaluating the safety, tolerability, and efficacy of a topical minocycline foam, FMX103, for the treatment of facial papulopustular rosacea. [published online February 2, 2018]. Am J Clin Dermatol. doi:10.1007/s40257-017-0339-0