NCT06770127

Efficacy of La Roche Posay Routine in the Management of Facial Post Inflammatory Hyperpigmentation (PIHP)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Cosmetique Active International · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to test and compare La Roche Posay routine --the studied product-- with a comparator product in participants with acne. The main question it aims to answer is how well can the product de-pigment the skin. The participants will be asked to use the products given twice daily. Researchers will compare the routine La Roche Posay group(experimental) with the routine Eucine group(control) to see if the La Roche product shows superiority in case of better efficacy.

Detailed description

The sample size of this study is 80 participants; 40 subjects testing Niacinamide A serum and UV Mune and 40 subjects testing Eucerin Thiamidol anti-pigment serum and Eucerin SPF 50+. The secondary objectives are: * the effect on the cutaneous acceptability by clinical examination under dermatological control * the effect of the product on acne lesions is assessed by comparing the number of elements on the face before application and after product use * the effect on acne severity according to the Global Acne Evaluation * the mean darkness of the post-inflammatory hyper-pigmentation (PIHP) lesions. A statistical analysis of the following will be done: a comparison of the before/after application, a comparison of the values obtained from the comparison product/comparator product, and a comparison PIHP lesion/normal zone. The study endpoints are: * global acne evaluation scale * mean size, intensity, number of PIHP lesion * mean darkness of lesions * subject global assessment score * improvement in scores in a stigmatization questionnaire * satisfaction questionnaire

Conditions

• Acne
• Postinflammatory Hyperpigmentation

Timeline

• Start date: 2023-02-27
• Primary completion: 2023-10-16
• Completion: 2023-10-16
• First posted: 2025-01-13
• Last updated: 2025-01-13

Locations

1 site across 1 country: Mauritius