17800 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

Document Type

Conference Proceeding

Publication Date

12-2020

Publication Title

Journal of the American Academy of Dermatology

Abstract

Objective: To assess the long-term safety, efficacy, and tolerability of FMX103 1.5% in moderate to severe facial papulopustular rosacea.

Methods: Eligible subjects were enrolled in a 40-week open-label extension (OLE) study at the final study visit of 2 identical phase 3, randomized, double-blind, vehicle-controlled, 12-week studies. Subjects initially enrolled in the FMX103 group continued to receive active treatment, while those previously in the vehicle group crossed over to receive active treatment in the OLE. Safety and efficacy and tolerability were assessed over 40 weeks.

Results: Of the 504 subjects enrolled, 81.3% of subjects completed the OLE. The majority of TEAEs were mild to moderate in severity (overall 94.0%). Except for one case of severe pruritus (probably related), all severe TEAEs and all serious adverse events were considered to be unrelated to the study treatment. At week 40, most subjects from both groups reported no symptoms or only mild symptoms of burning/stinging (100%), flushing/blushing (94.5%), dryness/xerosis (98.5%), itching (99.5%), peeling/desquamation (99.0%), or hyperpigmentation (99.3%). Overall, the mean reduction from baseline in absolute inflammatory lesion count, and the percent change at week 40 was 22.8 and 82.3%, respectively. The IGA treatment success rate from baseline of the double-blind study to week 40 was 79.8%.

Conclusions: FMX103 1.5% demonstrated efficacy in the treatment of moderate to severe facial papulopustular rosacea and appeared to be safe and well tolerated for up to an additional 40 weeks of treatment.

Volume

83

Issue

6

First Page

AB199

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