Efficacy of Extended-Release 45 mg Oral Minocycline and Extended-Release 45 mg Oral Minocycline Plus 15% Azelaic Acid in the Treatment of Acne Rosacea

March 2013 | Volume 12 | Issue 3 | Original Article | 292 | Copyright © March 2013

J. Mark Jackson MD,a Douglas J. Lorenz PhD,b and Leon H. Kircik MDc-e

aDivision of Dermatology, bDepartment of Bioinformatics and Biostatistics, University of Louisville, Louisville, KY cMount Sinai Medical Center, New York, NY dIndiana University School of Medicine, Indianapolis, IN ePhysicians Skin Care, PLLC, Louisville, KY

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week 8 to week 12 in either treatment group (P≥.06). The ER minocycline group experienced a significant week 8 to week 12 decrease in IGA (P=.04), while the ER minocycline + azelaic acid 15% group did not (P=.22).
Neither treatment was superior with respect to reduction in any outcome variable in any time interval. Specifically, 2-sample comparisons of visit-to-visit changes showed that the ER minocycline and ER minocycline + azelaic acid 15% groups did not significantly differ with respect to visit-to-visit change up to week 12 (P>.31).
After discontinuation of treatment at week 12, there were no significant changes in lesion count, IGA, or CEA in either treatment group to week 16 (P≥.33), and groups did not differ in changes after week 12 on any study outcome (P≥.32).

Safety Analyses

Twenty-seven subjects experienced a total of 44 AEs. Subjects in the ER minocycline + azelaic acid 15% group were more likely to experience an AE (16 of 30, 53%) than those in the ER minocycline group (11 of 30, 37%), although this difference was nonsignificant (CMH test, P=.31). The number of AEs also did not significantly differ between groups (Poisson GLMM, P=.15).
Two AEs were classified as possibly related to the study medication—an upset stomach and generalized urticaria in separate patients both receiving ER minocycline + azelaic acid 15%. Four AEs in 3 patients (all receiving ER minocycline + azelaic acid 15%) were severe but not suspected to be related to the study medication (bilateral oophorectomy with dermoid cyst removal, gastric erosion after lap band surgery, a severe respiratory infection, and cholecystitis).

Sensitivity Analysis of Per-Protocol Population

The PP population was defined at each week of follow-up as those that did not deviate from the study protocol by (1) missing a visit or (2) having a visit outside of the allowable window for the given