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

Evaluation of Effaclar Duo+M on Inflammatory and Non-Inflammatory Lesions in Subjects With Mild to Moderate Acne on Face and Trunk (Back and Chest)

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.

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.

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