Peter W. Hashim MD MHS,a Tinley Chen BA,a Julie C. Harper MD,b and Leon H. Kircik MDa,c,d
aThe Icahn School of Medicine at Mount Sinai, Department of Dermatology, New York, NY bThe Dermatology and Skin Care Center of Birmingham, Birmingham, AL cIndiana University School of Medicine, Indianapolis, IN dPhysicians Skin Care PLLC, Louisville, KY
sinus infection. One serious adverse event of bronchitis, moderate severity, was reported and determined to be unrelated to study medication. No therapy was initiated, and the event resolved with no residual effects.
Over a 16-week period, treatment with azelaic acid 15% foam led to decreases in the number of total, inflammatory, and non-inflammatory lesions in subjects with moderate-to-severe facial acne. Subjects showed an average 77% reduction in inflammatory lesion counts, 64% reduction in non-inflammatory lesion counts, and 73% reduction in total lesion counts. Reductions in lesion counts were supported by static physician assessments of facial severity, with a majority of subjects rated as “clear” or “almost clear” by the conclusion of the study. Azelaic acid 15% foam was well-tolerated on the facial area, and questionnaire results indicated that subjects viewed the foam vehicle as easily applicable and cosmetically appealing. Future research should expand upon this work in larger sample sizes and with vehicle control as well as active comparators. This study establishes azelaic acid 15% foam as a promising, safe, and efficacious therapy option for patients with moderate-to-severe facial acne.
Dr. Hashim and Tinley Chen have no conflicts of interest to disclose. Dr. Harper is a consultant, researcher, and speaker for Bayer HealthCare Pharmaceuticals Inc. Dr. Kircik has served as an advisor, investigator, consultant, and speaker for Allergan, Bayer, Galderma, Promius Pharma, Sun Pharma, Stiefel/GSK, LeoPharma, Taro, Valeant, and Warner-Chilcott. This study was funded by Bayer as an investigator-initiated study.
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