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A 10% glycolic acid containing oil‐in‐water emulsion improves mild acne: a randomized double‐blind placebo‐controlled trial
Author(s) -
Abels Christoph,
Kaszuba Alexandra,
Michalak Iwonna,
Werdier Dieter,
Knie Ulrich,
Kaszuba Andrzej
Publication year - 2011
Publication title -
journal of cosmetic dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.626
H-Index - 44
eISSN - 1473-2165
pISSN - 1473-2130
DOI - 10.1111/j.1473-2165.2011.00572.x
Subject(s) - tolerability , glycolic acid , medicine , placebo , acne , randomized controlled trial , clinical trial , adverse effect , randomization , dermatology , lactic acid , alternative medicine , pathology , biology , bacteria , genetics
Summary Background Acne is characterized by hyperseborrhea, follicular hyperkeratosis, and growth of propionibacteria. Alpha hydroxy acids depending on the pH of the finished product exhibit comedolytic as well as antimicrobial properties. Objectives The aim of this study was to investigate an oil‐in‐water emulsion‐containing 10% glycolic acid (pH 4; Dr. August Wolff GmbH & Co. KG Arzneimittel, Bielefeld, Germany) as monotherapy in mild acne regarding clinical efficacy and tolerability for 90 days. Patients and methods Patients ( n = 120; 73 f, 47 m) suffering from mild acne (Leeds score 0.25–1) aged ≥12 (mean 21 ± 5.8) were included in this double‐blind, placebo‐controlled, randomized, monocentric trial. The cream was applied once daily in the evening. No additional products were used. Cleansing was standardized by supplying the same product to all patients. Results The number of patients ( n = 115) in the per‐protocol and intention‐to‐treat analysis was the same. Acne improved significantly in the verum group up to day 90. Already at day 45, there was a statistical significant (5% level) difference against placebo. The subjective evaluation of the verum by physicians and patients regarding clinical efficacy and tolerability was favorable. Regarding reported adverse effects, there was no statistically significant difference (5% level) between verum and placebo. Conclusions The 10% glycolic acid containing oil‐in‐water emulsion improved mild acne applied as monotherapy in this study significantly, already after 45 days of treatment. Regarding tolerability, there was no objective or subjective difference between the 10% glycolic acid containing oil‐in‐water emulsion and the corresponding placebo.