Ketoconazole (KTZ) cream demonstrated significant overall improvement as a treatment in patients with mild adult female acne (AFA) and possesses an excellent safety profile, according to study data published in The Journal of Dermatology.
KTZ cream, a topical antifungal with anti-inflammatory and antiandrogenic actions, can decrease the lipase activity of Cutibacterium acnes in vitro. To demonstrate the efficacy and safety of KTZ on AFA, researchers conducted a randomized placebo-controlled parallel study at a single tertiary care center in Thailand that included 41 patients (age 25-49 years) with mild AFA who applied KTZ 2% and placebo cream twice daily for 8 weeks. To assess the lasting effect of KTZ therapy, patients continued with routine skincare routines during a post-treatment period of 2 weeks. The percentage of patients with acne improvement from baseline (42.9% vs 9.5%, P =.015) and the success rate (45.0% vs 14.3%, P =0.043) in the KTZ group were significantly higher than in the placebo group. The most common adverse events reported were dryness and itching. Interestingly, the investigators noted, the percentage change of acne count decreased significantly compared with baseline but did not differ statistically between the 2 groups (P =.268).
The researchers noted a shorter study period and lack of generalizability of findings to patients with moderate to severe AFA, adolescent acne, or acne in men as study limitations.
“Given the significant efficacy and excellent safety profile, our study revealed a potential role of KTZ monotherapy as a viable acne treatment without concern of antibiotic resistance,” stated the authors. They added that, “it should be considered as an alternative therapy to the standard treatments for mild AFA patients.”
Chottawornsak N, Chongpison Y, Awawanonda P, Kumtornrut C. Topical 2% ketoconazole cream monotherapy significantly improves adult female acne: a double-blind, randomized placebo-controlled trial. J Dermatol. 2019;46:1184-1189.