FMX103 1.5%, a topical minocycline, is superior to vehicle for managing moderate to severe papulopustular rosacea and reducing the number of inflammatory lesions associated with this disease, according to study data published in the Journal of the American Academy of Dermatology. In addition, the study found that the topical formulation of minocycline features a favorable safety profile with no associated serious treatment-related or treatment-emergent adverse events.
These findings were according to an analysis of FX2016-11 and FX2016-12, which were 2 identical 12-week, randomized, vehicle-controlled studies of FMX103 1.5%. In these studies, adult patients with moderate to severe papulopustular rosacea, involving 15 to 75 facial papules and pustules and ≤2 facial nodules, were enrolled. Patients enrolled in these studies also had either a history or presence of facial erythema and/or flushing.
In the first study, a total of 494 patients were randomly assigned to FMX103 1.5% and 256 patients were randomly assigned to vehicle control. The second study randomly assigned 514 patients to FMX103 1.5% and 257 patients to vehicle control. The coprimary efficacy endpoints included the absolute change from baseline to 12 weeks in the inflammatory lesion count as well as the percentage of patients achieving endpoint success.
A significantly greater reduction in the number of inflammatory lesions was observed with FMX103 1.5% vs vehicle in FX2016-11 (-17.57 vs -15.65, respectively; P =.0031) and FX2016-12 (-18.54 vs -14.88, respectively; P <.0001) studies. In addition, the investigators found higher rates of Investigator Global Assessment treatment success with FMX103 1.5% in the FX2016-11 (52.1% vs 43.0%; P =.0273) and FX2016-12 (49.1% vs 39.0%; P =.0077) studies. Neither study reported any serious treatment-related or treatment-emergent adverse events. Only 1 patient who discontinued a study did so because of an adverse event that may have been related to treatment.
Study limitations include the relatively short treatment periods as well as the potential lack of ethnic diversity in the patient cohorts.
Evidence from these studies suggests “that this novel, topical minocycline foam exhibits potential as an appropriate option for the topical treatment of moderate-to-severe papulopustular rosacea.”
Disclosure: This clinical trial was supported by Foamix Pharmaceuticals Inc. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Gold LS, Del Rosso JQ, Kircik L, et al. Minocycline 1.5% foam for the topical treatment of moderate-to-severe papulopustular rosacea: results of two phase 3, randomized, clinical trials. J Am Acad Dermatol. doi: 10.1016/j.jaad.2020.01.043