Efficacy Study of Cosmetic Product RV3278AET0943 Versus Non-treated Group in Adults With Oily and Acne Prone Skin

Acne Clinical Trial

Official title: RV3278AET0943 Cosmetic Product Efficacy Applied for 8 Weeks in Adults Having Oily and Acne Prone Skin: Comparative Study Versus Not Treated Group

Status Completed

Clinical Trial Summary

The aim of this study is to evaluate, at different times, the RV3278A - ET0943 cosmetic product efficacy after 8 weeks of application on the face (twice-daily application). At T1 (Baseline), T2 (4 weeks) and T3 (8 weeks), the following assessments are performed:

• The reduction of the pilosebaceous follicular ostium size in vivo (pores) on the forehead

• The clinical evaluation (count of non inflammatory and inflammatory acne lesions, IGA score) of the face

• The reduction in visible follicles

• The standardized numerical photographs of face and ¾ right and left profile in normal, parallel polarized, cross polarized and UV light

• The analysis of the skin lipids of the forehead

• The qualitative and quantitative analysis of the sebum and comedones constituents (nose wings)

This is a comparative, open-labelled study, on subjects with oily and acne prone skins on the face.

Each group includes 18 subjects.

Clinical Trial Description

This study is monocentric, comparative versus non-treated group, open-labelled, exploratory, conducted in adults having oily and acne prone skin.

The study includes 4 visits for each group, including subjects' selection:

• V0: Subjects' selection

• V1: Baseline inclusion

• V2: 4 weeks, follow-up visit

• V3: 8 weeks, study end

The maximal study duration is 61 days. The front, temporal areas and nose wings are defined as the study interest areas for superficial samples.

The evaluation is at 3 times: T1 baseline, T2 at 4 weeks and T3 at 8 weeks of application of RV3278A formula ET0943 with comparison of each time versus baseline.

There are twice-daily applications (morning and evening) of the test product on the face. ;

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

• NCT number: NCT04873089
• Study type: Observational
• Source: Pierre Fabre Dermo Cosmetique
• Status: Completed
• Start date: September 17, 2018
• Completion date: December 21, 2018