RESUMO
OBJECTIVE: We investigated the efficacy and tolerability of nicotinamide cream plus an antibacterial adhesive agent and zinc-pyrrolidone carboxylic acid compared to placebo in patients with moderate acne vulgaris (MAV) in Indonesia. METHODS: This was a multicenter, double-blind, randomized, placebo-controlled, parallel-group study conducted in five teaching hospitals in Indonesia from August 2016 to January 2017. Eligible participants included 140 patients with MAV, aged 12 to 50 years, who were enrolled and randomly divided into two groups to receive either adapalene and the study formulation or adapalene and a placebo cream twice daily for six weeks. Clinical response and treatment efficacy were assessed through acne lesion counts, presence of side effects, and patient satisfaction at the second, fourth, and sixth weeks after the first visit. RESULTS: A total of 140 subjects from five different centers (28 subjects in each center) were enrolled. One hundred twenty-seven subjects completed the study, including 63 subjects in the study group and 64 subjects in the placebo group. A significant decrease in the number of noninflammatory lesions in the second week was noted in the study group compared to in the placebo group. There were no significant differences in adverse effects between the two groups in the second and fourth weeks. CONCLUSION: Treatment using nicotinamide plus an antibacterial adhesive agent and zinc-pyrrolidone carboxylic acid was effective in reducing noninflammatory lesions by the second week of therapy. ClinicalTrials.gov registration no. NCT0326298.