Topical ketoconazole (KTZ) 2% cream was moderately effective for reducing mild acne in adult women, according to study data published in the Journal of Dermatology.
Investigators conducted a randomized double-blind placebo-controlled study at a single tertiary care center in Bangkok, Thailand. Patients with mild adult female acne (AFA) were enrolled and randomly assigned 1:1 to receive KTZ 2% or placebo cream twice daily for 8 weeks. At the end of week 8, patients discontinued the study product but continued with routine skincare for a 2-week post-treatment period. Study assessments were conducted at weeks 2, 4, 6, 8, and 10. The primary end point was percent change in acne count from baseline to week 8. Clinical acne severity was measured using the AFA Scoring Tool (AFAST) for the face (AFAST-F) and submandibular area (AFAST-S). Treatment success rate was calculated as the percentage of patients who achieved 0 (“clear”) or 1 (“almost clear”) AFAST scores at weeks 8 and 10.
The study enrolled 41 women with mild AFA, of whom 39 (95.1%) completed the 10-week study period. Patient age ranged from 25 to 49 years, with mean values of 35.2 and 34.1 years in the KTZ and placebo groups, respectively. Mean acne counts at week 8 were significantly lower than at baseline in both the KTZ (P <.001) and placebo (P =.002) groups. The mean percent change of acne counts was not significantly different between groups (P =.268). The percentage of patients achieving a 1-grade reduction in AFAST from baseline to week 8 was greater in the KTZ group vs the placebo group (42.9% vs 9.5%; P =.015). In addition, 45.0% of patients receiving KTZ achieved AFAST scores of 0 or 1 at week 8 compared with just 14.3% of the placebo group (P =.043). No significant between-group differences were observed in AFAST-F scores during the post-treatment period or in AFAST-S scores at weeks 8 and 10. No serious or major adverse events were reported during the trial. The most common adverse events in the KTZ group were itching (25%) and dryness (15%), which spontaneously resolved without KTZ discontinuation.
The data support the efficacy and safety of KTZ monotherapy for mild AFA. Study results are not generalizable to women with moderate and severe AFA, adolescents with acne, or men with acne. The short treatment period may also limit study conclusions; the long-term efficacy of KTZ cream could not be ascertained.
“Future studies of topical KTZ or other antifungals are required to confirm the promising efficacy, including [studies with] larger sample sizes, longer follow-up periods and more varied clinical settings,” the investigators wrote.
Chottawornsak N, Chongpison Y, Asawanonda P, Kumtornrut C. Topical 2% ketoconazole cream monotherapy significantly improves adult female acne: a double-blind, randomized placebo-controlled trial [published online October 9, 2019]. J Dermatol. doi:10.1111/1346-8138.15113