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

Cosmetique Active

Status

Enrolling

Conditions

Acne

Treatments

Other: acneic participants group

Study type

Interventional

Funder types

Industry

Identifiers

NCT06463925

LRP23014-2223CBCL059 Effaclar

Details and patient eligibility

About

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.

Full 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.

Enrollment

65 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

phototype I to VI
mild to moderate acne on the face and trunk

Exclusion criteria

cutaneous pathology on the studied zone other than acne
topical or systemic treatment during the previous weeks liable to interfere with the assessment of the acceptability and efficacy of the studied products