NCT06659861

Efficacy of Cosmetic Product RV3278B-OS0386 on Skin Surface Ecosystem, in Teenagers with Mild to Moderate Facial Acne

An Exploratory Randomized Comparative Study to Evaluate the Effect of RV3278B-OS0386 on Skin Ecosystem, in Teenagers with Mild to Moderate Facial Acne

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Pierre Fabre Dermo Cosmetique · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The aim of this exploratory study is to better understand the mechanisms of action of the RV3278B-OS0386 cosmetic product on the cutaneous ecosystem, in acne context.

Detailed description

This study will be conducted as an exploratory monocentric, randomized, comparative study. A total number of 52 subjects (teenagers with mild to moderate facial acne) will be included and randomized in two parallel groups : * The tested group who will apply the tested product RV3278B-OS0386 * The control group who will not apply the tested product. However, they will receive the associated product (RV4632A-RY1845), to be applied in the event of facial skin discomfort only. 3 visits are planned: * Visit 1 (Day 1) : Inclusion, randomization, collection of biological samples on the forehead and start of product application. * Visit 2 (Day 29 +/- 3 days) : Phone call follow-up * Visit 3 (Day 57, a window of + 3 days is allowed): End-of-study visit - Collection of biological samples on the forehead.

Conditions

• Acne

Interventions

Type	Name	Description
OTHER	RV3278B-OS0386	Cosmetic product to be applied twice a day on the face during the whole study
OTHER	RV4632A-RY1845	Cosmetic product to be applied in the event of facial skin discomfort only

Timeline

• Start date: 2024-10-10
• Primary completion: 2025-03-06
• Completion: 2025-03-06
• First posted: 2024-10-26
• Last updated: 2025-03-17

Locations

1 site across 1 country: Romania