NCT04873089

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 37 (actual)
• Sponsor: Pierre Fabre Dermo Cosmetique · Industry
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Acne

Interventions

Type	Name	Description
OTHER	Cosmetic product	It is a comparative study with two parallel groups of subjects: * Tested group: twice daily application of the cream RV3278A cosmetic product on the whole face * Comparative group: no application of study product or reference product

Timeline

• Start date: 2018-09-17
• Primary completion: 2018-12-21
• Completion: 2018-12-21
• First posted: 2021-05-05
• Last updated: 2021-05-05

Locations

1 site across 1 country: France