NCT06463925

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Cosmetique Active International · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Acne

Interventions

Type	Name	Description
OTHER	acneic participants group	Application of Effaclar Duo+M to the face and trunk twice daily (morning and evening) after washing with the cleansing gel.

Timeline

• Start date: 2023-12-07
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2024-06-18
• Last updated: 2024-06-18

Locations

1 site across 1 country: Brazil