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

NCT05216289 | Completed Phase 4

• 1 other identifier: Probiac
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

probiotic; acne; adapalene; benzoyl peroxide; microbiome

Outcome Measures

Primary Outcomes (6)

• Investigator Global Assessment (IGA)

  patients were clinically evaluated and the results in relation to the Investigator Global Assessment (IGA)

  day 30

• Investigator Global Assessment (IGA)

  patients were clinically evaluated and the results in relation to the Investigator Global Assessment (IGA)

  day 60

• Investigator Global Assessment (IGA)

  patients were clinically evaluated and the results in relation to the Investigator Global Assessment (IGA)

  day 90

• Investigator Global Assessment (IGA)

  patients were clinically evaluated and the results in relation to the Investigator Global Assessment (IGA)

  day 120

• Investigator Global Assessment (IGA)

  patients were clinically evaluated and the results in relation to the Investigator Global Assessment (IGA)

  day 150

• Investigator Global Assessment (IGA)

  patients were clinically evaluated and the results in relation to the Investigator Global Assessment (IGA)

  day 180

Secondary Outcomes (6)

• Lesion

  day 30

• Lesion

  day 60

• Lesion

  day 90

• Lesion

  day 120

• Lesion

  day 150

Study Arms (2)

probiac + topical fixed combination

ACTIVE COMPARATOR

Dietary Supplement: Probiac

placebo + topical fixed combination

PLACEBO COMPARATOR

Other: Placebo

Interventions

Probiac DIETARY_SUPPLEMENT

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.

probiac + topical fixed combination

Placebo OTHER

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

placebo + topical fixed combination

Eligibility Criteria

• Age: 12 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• participants of both genders aged between 12 and 35 years, acne grade II and III acne mixed or oily skin phototype between I and IV, according to the Fitzpatrick scale, were recruited

You may not qualify if:

• Pregnant or lactating women, as well as those intending to become pregnant during the study period patients who received treatment with corticosteroids and antimicrobials within 30 days prior to selection patients who were treated with immunosuppressants within 90 days prior to selection.

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Medcin Instituto da Pele Ltda: collaborator

Study Sites (1)

Medcin Instituto da Pele Ltda

São Paulo, São Paulo, 06023-000, Brazil

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A randomized, double-blind, placebo-controlled clinical trial

Study Record Dates

• First Submitted: December 19, 2021
• First Posted: January 31, 2022
• Study Start: April 1, 2018
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: January 31, 2022

Record last verified: 2022-01

Locations

BR (1)