NCT05216289 is a Phase 4 clinical trial of Probiac in Acne Vulgaris, sponsored by Federal University of São Paulo.

Who is sponsoring NCT05216289?

NCT05216289 is sponsored by Federal University of São Paulo.

What drugs are being tested in NCT05216289?

Interventions in NCT05216289: Probiac, Placebo.

What condition does NCT05216289 study?

NCT05216289 studies Acne Vulgaris.

Is NCT05216289 still recruiting?

NCT05216289 is currently completed. Last updated 31 January 2022.

Last reviewed 2022-01-31 · How we verify

NCT05216289

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 4 Last updated 31 January 2022

What this trial tests

Phase 4 trial testing Probiac in Acne Vulgaris in 400 participants. Completed in 1 April 2021.

Timeline

1 April 2018

Primary endpoint
1 April 2021

1 April 2021

Quick facts

Lead sponsor	Federal University of São Paulo
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	400
Start date	1 April 2018
Primary completion	1 April 2021
Estimated completion	1 April 2021
Sites	1 location across Brazil

Drugs / interventions tested

Probiac
Placebo

Conditions studied

Acne Vulgaris — all drugs for Acne Vulgaris →

Sponsor

Federal University of São Paulo

Who can join

Adults 12 to 35, any sex, with Acne Vulgaris. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Acne Vulgaris

Currently open trials in the same condition.

NCT07341087 — Skin Inflammation in Perimenopause: A Probiotic Intervention Proof of Concept Trial · NA · recruiting
NCT07474883 — Efficacy of 0.5% Topical Timolol Eye Drops in the Treatment of Post-Inflammatory Erythema Following Acne Vulgaris · EARLY_PHASE1 · recruiting
NCT07186413 — A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne · Phase 3 · recruiting
NCT07056673 — Cold Atmospheric Plasma for Moderate-to-severe Acne Vulgaris Study · NA · recruiting
NCT07102186 — Efficacy and Safety of Adapalene Gel and Hyaluronic Acid Versus Adapalene Gel Alone in Mild to Moderate Acne Vulgaris · Phase 4 · recruiting

Other Federal University of São Paulo trials

Trials by the same sponsor.

NCT07376811 — Effect Of Sleeping Posture Guidance On Sleep Quality In Patients With Rotator Cuff Syndrome · NA · not yet recruiting
NCT06805656 — Multi Interventional Approaches to Mitigate HIV Reservoirs Aiming the Sustained HIV Remission Without Antiretrovirals · Phase 2 · not yet recruiting
NCT06970964 — Fermented Milk Drink With Lacticaseibacillus Paracasei Strain Shirota Helps Triathletes With Cold-Like Symptoms Before a · NA · completed
NCT06905860 — Intra-articular Infiltration of Platelet-Rich Fibrin vs Corticosteroid in Mild to Moderate Knee Osteoarthritis · Phase 4 · not yet recruiting
NCT06829992 — Effects of Applying Kinesio Tapping on Primary Dysmenorrhea in Football Players · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05216289 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Federal University of São Paulo
Last refreshed: 31 January 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05216289.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing