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

INTRODUCTION: Acne is a chronic inflammatory disease of the pilosebaceous unit of multifactorial origin, which causes a significant impact on quality of life. OBJECTIVE: Clinical trial assessing the superiority of efficacy of a treatment regimen with an oral probiotic associated with a fixed combination of adapalene 0.1% and benzoyl peroxide 2.5% compared to an oral placebo with the same topical treatment in patients with acne. METHODS: This was a randomized, double-blind, placebo-controlled study conducted with 212 patients aged from 12 to 35 years. The study was divided into two phases of 90 days each. In the first phase, patients received treatment with adapalene 0.1% and benzoyl peroxide 2.5% associated with a probiotic (IT), or adapalene 0.1% and benzoyl peroxide 2.5% associated with placebo (CT). In the second phase (90 days), patients received only oral treatment with a probiotic or placebo. Efficacy criteria were: reduced 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 control (p