Topical 2% ketoconazole cream monotherapy significantly improves adult female acne: A double-blind, randomized placebo-controlled trial.

Abstract

The emergence of bacterial resistance is a global crisis. Prolonged use of antibiotics especially in acne is one issue of concern among dermatologists. Ketoconazole (KTZ) cream, a topical antifungal with anti-inflammatory and antiandrogenic actions, can decrease lipase activity of Cutibacterium acnes in vitro. We evaluated the efficacy and safety of KTZ cream in mild adult female acne (AFA) by conducting a randomized, double-blind, placebo-controlled trial using KTZ 2% and placebo cream twice daily for 10weeks. We assessed the improvement of clinical severity, measured by AFA score graded by investigators and participants, and the change of acne count. Forty-one participants enrolled in our study. The proportion of participants with acne improvement from baseline (42.9% vs 9.5%, P=0.015) and the success rate (45.0% vs 14.3%, P=0.043) in the KTZ group were significantly higher than that of the placebo group. The most common adverse events were dryness and itching. The percentage change of acne count decreased significantly compared with baseline but did not differ statistically between the two groups (P=0.268). We concluded that the KTZ monotherapy showed a plausible effect in improving AFA with excellent safety profile. It should be considered as a viable option for mild AFA treatment.