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The Efficacy of an Oral Probiotic Associated With a Fixed Combination of Benzoyl Peroxide and Adapalene in the Treatment of Acne

NCT05216289 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2022-01-31

No results posted yet for this study

Summary

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.

Conditions

  • Acne Vulgaris

Interventions

DIETARY_SUPPLEMENT

Probiac

Oral probiotic composed of Lactobacillus acidophilus, Bifidobacterium lactis, vitamins and minerals - Exímia Probiac® (EP), in combination with 2.5% benzoyl peroxide plus 0.1% adapalene (PBA) for topical use.

OTHER

Placebo

Placebo + 2.5% benzoyl peroxide plus 0.1% adapalene (PBA) for topical use.

Sponsors & Collaborators

  • Medcin Instituto da Pele Ltda

    collaborator UNKNOWN

  • Federal University of São Paulo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2021-04-01
Completion
2021-04-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05216289 on ClinicalTrials.gov