The following article is part of coverage from the American Academy of Dermatology’s Annual Meeting (AAD 2020). Because of concerns regarding the coronavirus disease 2019 (COVID-19) pandemic, all AAD 2020 sessions and presentations were transitioned to a virtual format. While live events will not proceed as planned, readers can click here to view more news related to research presented during the AAD VMX 2020 virtual experience.
A novel topical minocycline foam was effective in the treatment of moderate to severe facial papulopustular rosacea, according to study results presented at the American Academy of Dermatology’s Virtual Meeting Experience (AAD VMX) 2020, held online from June 12 to 14, 2020.
This 40-week open-label extension study began at the end of 2 Phase 3, randomized clinical trials of topical minocycline foam for the treatment of rosacea. The foam—FMX103 1.5%—is intended to reduce inflammatory lesions and other rosacea symptoms. Patients initially enrolled in the FMX103 arm of the randomized clinical trials were offered to continue in the open-label extension period. Patients in the placebo arm were also offered to switch to active treatment for the open-label study. Safety, efficacy, and tolerability were assessed over 40 weeks.
Of 504 patients enrolled in the extension period, 81.3% completed 40 weeks of follow-up. Mean reduction from baseline to week 40 in absolute inflammatory lesion count, and the percent change at week 40, was 22.8 and82.3%, respectively. Treatment success, defined by the Investigators Global Assessment Scale, was achieved by 79.8% of participants at week 40. The majority (94.0%) of treatment-emergent adverse events were of mild or moderate severity. Most serious adverse events were determined to be unrelated to treatment. One case of severe pruritus was reported, likely related to treatment. The most common adverse events were burning/stinging, flushing/blushing, and dryness/xerosis.
As study limitations, the investigators acknowledged that, ”Because of the nature of the open-label study, no inference can be made on comparability due to the absence of a vehicle-treated control.”
In line with data from the preceding randomized clinical trials, FMX103 1.5% maintained efficacy and tolerability over the 40-week extension period. No minocycline-induced hyperpigmentation was observed. Satisfaction levels were high, with >80% of patients reporting that they were “satisfied” or “very satisfied” with FMX103 1.5%.
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Mathew M, Del Rosso JQ, Kircik L, et al. Open-label extension study evaluating the long-term safety, efficacy, and tolerability of FMX103 1.5% topical minocycline foam in the treatment of moderate-to-severe facial papulopustular rosacea. Presented at: AAD VMX 2020; June 12-14, 2020. Abstract/Poster 17800.