Efficacy and Tolerability of Topical Nicotinamide plus Antibacterial Adhesive Agents and Zinc-Pyrrolidone Carboxylic Acid Versus Placebo as an Adjuvant Treatment for Moderate Acne Vulgaris in Indonesia: A Multicenter, Double-blind, Randomized, Controlled Trial

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 ffive 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 effiects, and patient satisfaction at the second, fourth, and sixth weeks after the ffirst visit. RESULTS: A total of 140 subjects from ffive diffierent centers (28 subjects in each center) were enrolled. One hundred twentyseven subjects completed the study, including 63 subjects in the study group and 64 subjects in the placebo group. A signifficant decrease in the number of noninffiammatory lesions in the second week was noted in the study group compared to in the placebo group. There were no signifficant diffierences in adverse effiects 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 effiective in reducing noninffiammatory lesions by the second week of therapy. ClinicalTrials.gov registration no. NCT0326298.