The efficacy of an oral probiotic associated with a fixed combination of benzoyl peroxide and adapalene in the treatment of acne: A randomized, double-blind, placebo-controlled clinical trial.

Abstract Objective : Clinical trial carried out to evaluate the superiority of efficacy of a treatment regimen with an oral probiotic associated with a fixed combination of 0.1% adapalene and 2.5% benzoyl peroxide compared to an oral placebo with the same topical treatment in patients with mild to moderate acne. Patients and Methods: This was a randomized, double-blind, placebo-controlled study conducted with 212 patients aged from 12 to 35 years; 107 in the test treatment arm and 105 in the comparator arm. The study was divided into two phases of 90 days each, totaling 180 days. In the first phase, patients received treatment with 2.5% benzoyl peroxide and 0.1% adapalene associated with a probiotic (IT), or 2.5% benzoyl peroxide and 0.1% adapalene associated with placebo (CT). In the second phase (90 days), patients received only oral treatment with a probiotic or placebo. Efficacy criteria were: reduction of the Investigator Global Assessment (IGA) scale to 0 or 1, and reduced lesion count. Results: There was a significant difference in the proportion of participants with IGA 0 or 1 – the arm receiving the test treatment was superior to the comparator group at all study time points (30, 60, 90, 120, 150 and 180 days) (p<0.05). Regarding lesion counts, the test arm was superior, although this difference was not statistically significant. Both treatments were safe and well tolerated. Conclusion: In light of the evidence on efficacy and safety, treatment with probiotics should be considered as an adjuvant therapy for acne control.