A novel topical minocycline foam for the treatment of moderate-to-severe acne vulgaris: Results of 2 randomized, double-blind, phase 3 studies Linda.

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Date of download: 6/21/2016 Copyright © 2016 American Medical Association. All rights reserved. From: Adapalene Gel, 0.1%, as Maintenance Therapy for Acne.

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A novel topical minocycline foam for the treatment of moderate-to-severe acne vulgaris: Results of 2 randomized, double-blind, phase 3 studies Linda Stein Gold, MD, Sunil Dhawan, MD, Jonathan Weiss, MD, Zoe Diana Draelos, MD, Herman Ellman, MD, Iain A. Stuart, PhD Journal of the American Academy of Dermatology Volume 80, Issue 1, Pages 168-177 (January 2019) DOI: 10.1016/j.jaad.2018.08.020 Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

Fig 1 Subject disposition. AE, Adverse event. Journal of the American Academy of Dermatology 2019 80, 168-177DOI: (10.1016/j.jaad.2018.08.020) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

Fig 2 Coprimary end points. A, Absolute change in inflammatory lesion count from baseline at week 12 in study 04, study 05, and the pooled analysis. B, Proportion of subjects achieving treatment success according to the Investigator's Global Assessment (score of clear [0] or almost clear [1] with at least 2 grades of improvement from baseline) at week 12 in study 04, study 05, and the pooled analysis. aAnalysis of covariance (ANCOVA) analysis, intent-to-treat (ITT) population, multiple imputation. bCochrane-Mantel-Haenszel test (risk ratio [RR], FMX101 4%/vehicle), ITT population, multiple imputation. Journal of the American Academy of Dermatology 2019 80, 168-177DOI: (10.1016/j.jaad.2018.08.020) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

Fig 3 Percentage reduction in inflammatory lesion count from baseline by visit in study 04 and study 05. aAnalysis of covariance (ANCOVA) analysis, intent-to-treat (ITT) population, multiple imputation. *P ≤ .0001. †P ≤ .001. ‡P < .01. Journal of the American Academy of Dermatology 2019 80, 168-177DOI: (10.1016/j.jaad.2018.08.020) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

Fig 4 Absolute change in noninflammatory lesion count from baseline at week 12 in study 04, study 05, and pooled analysis. aAnalysis of covariance (ANCOVA) analysis, intent-to-treat (ITT) population, multiple imputation. Journal of the American Academy of Dermatology 2019 80, 168-177DOI: (10.1016/j.jaad.2018.08.020) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

Fig 5 Results of the subject satisfaction questionnaire at week 12 (pooled analysis, N = 534). Journal of the American Academy of Dermatology 2019 80, 168-177DOI: (10.1016/j.jaad.2018.08.020) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions