Evaluation of Effaclar Duo+M on Acne Lesions in Subjects With Mild to Moderate Acne on Face and Trunk

Last updated: June 14, 2024
Sponsor: Cosmetique Active International
Overall Status: Active - Recruiting

Phase

N/A

Condition

Acne

Rash

Inflammatory Comedones

Treatment

acneic participants group

Clinical Study ID

NCT06463925
LRP23014-2223CBCL059 Effaclar
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This single-center, open, non-randomized study aims the efficacy evaluation of Effaclar Duo+M and Effaclar+M Purifying foaming gel on total acne lesion count, pigmented lesions and scars for 6 months in subjects with mild to moderate facial and truncal acne.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • phototype I to VI

  • mild to moderate acne on the face and trunk

Exclusion

Exclusion Criteria:

  • cutaneous pathology on the studied zone other than acne

  • topical or systemic treatment during the previous weeks liable to interfere with theassessment of the acceptability and efficacy of the studied products

Study Design

Total Participants: 65
Treatment Group(s): 1
Primary Treatment: acneic participants group
Phase:
Study Start date:
December 07, 2023
Estimated Completion Date:
September 30, 2024

Study Description

The study will be conducted in accordance with the principles of Resolution 466/2012 of the Conselho Nacional de Saúde do Brasil3, ethical principles from the Declaration of Helsinki (and subsequent modifications) and Good Clinical Practice.

Statistical methodology:

Quantitative variables, or those that can reasonably be treated as such, are summarized using the minimum, maximum, measures of central tendency such as the mean and median & measures of dispersion such as the standard deviation (SD). Qualitative variables are summarized in the form of counts and percentages.

Significance level:

The null hypothesis will generally be rejected if a p-value less than 0.05 (5% significance level) is produced by the statistical procedure.

Connect with a study center

  • CIDP Brasil

    Rio De Janeiro,
    Brazil

    Active - Recruiting

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