Efficacy and safety of a novel topical minocycline foam for the treatment of moderate to severe acne vulgaris: A phase 3 study
Tooraj Joseph Raoof, Deirdre Hooper, Angela Moore, Martin Zaiac, Tory Sullivan, Leon Kircik, Edward Lain, Jasmina Jankicevic, Iain Stuart, Tooraj Joseph Raoof, Deirdre Hooper, Angela Moore, Martin Zaiac, Tory Sullivan, Leon Kircik, Edward Lain, Jasmina Jankicevic, Iain Stuart
Abstract
Background: FMX101 4% topical minocycline foam has been shown to be an effective and safe treatment for acne vulgaris (AV).
Objective: To further evaluate the efficacy and safety of FMX101 4% in treating moderate to severe acne vulgaris.
Methods: A 12-week, multicenter, randomized (1:1), double-blind, vehicle-controlled study was conducted. Coprimary end points were the absolute change in inflammatory lesion count from baseline and the rate of treatment success (Investigator's Global Assessment score of 0 or 1 with a ≥2-grade improvement).
Results: There were 1488 participants in the intent-to-treat population. The FMX101 4% group had significantly greater reductions in the number of inflammatory lesions from baseline (P < .0001) and a greater rate of treatment success based on Investigator's Global Assessment (P < .0001) versus the foam vehicle group at week 12. FMX101 4% was generally safe and well tolerated.
Limitations: The efficacy and safety of FMX101 4% were not characterized in participants with mild AV.
Conclusion: FMX101 4% topical minocycline foam was effective and safe for the treatment of moderate to severe AV.
Keywords: acne vulgaris; clinical study; efficacy; foam; minocycline; randomized; safety; topical administration.
Copyright © 2019 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.
Source: PubMed