Assessment of a Cosmetic Product Effect on the Host/Microorganism Relationship in Acneic Subjects

Completed

• Conditions: Acne
• Interventions: Other: RV4632A - RY1845 cosmetic product; Other: RV3278A - ET0943 cosmetic product

• Registration Number: NCT05640388
• Lead Sponsor: Pierre Fabre Dermo Cosmetique

Brief Summary

The aim of the study is to understand the structural and functional modifications of the host, the microorganisms, and their interactions (host/microorganism relationship) before and after the RV3278A - ET0943 product application

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-20
• Primary Completion: 2022-01-12
• Study Completion: 2022-01-12
• Status Verified: 2022-11
• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2022-11-28
• Last Update Submitted: 2022-11-28
• Study First Posted: 2022-12-07
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

1. Related to the population:

   • Subject aged between 12 to 25 years included

2. Related to diseases:

   • Subject having acne lesions on the face, with GEA (Global Acne Evaluation) score on the face is assessed as 2 (mild) or as 3 (moderate), on a scale ranged from 0 (clear- no lesion) to 5 (very severe)
   • Subject having at least 20 open-comedones of about 1 mm in diameter on the face and possibly extractable
   • Subject having a predominance of non-inflammatory acne lesions

Exclusion Criteria

1. Related to diseases:

   • Subject having comedones only on the nose wings
   • Subject with any other dermatological disease than acne or skin characteristics (like scar, tatoo) on the face liable to interfere with the study according to the investigator's assessment
   • Subject with an acute or chronic disease, or history of disease liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
   • Severe form of acne (Acne conglobata, Acne fulminans or nodulokystic acne) or acneiform induced rashes according to the investigator's assessment
   • Clinical signs of a hormonal dysfunction or of a hyperandrogenism
   • Solar erythema on the face due to excessive UV exposur

2. Related to the treatments/products:

   • Any previous/concomitant treatment or product considered by the Investigator liable to interfere with the study data or incompatible with the study requirements or hazardous for the subject

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RV4632A arm : Control group	RV4632A - RY1845 cosmetic product	This group will receive the RV4632A - RY1845 product
RV3278A arm : Treated group	RV3278A - ET0943 cosmetic product	This group will receive the RV3278A - ET0943 product

Primary Outcome Measures

Name	Time	Method
Effect of the RV3278A on inflammatory and retentionnal lesions	Change from baseline to 2 months	Quantification of inflammatory and retentionnal lesions from image analysis
Effect of the RV3278A on metabolites	Change from baseline to 1 month	Metagenomic analysis on comedones samples
Effect of the RV3278A on acne severity	Change from baseline to 2 months	Global Evaluation Acne (GEA), on a 6-point scale 0: Clear. No lesions; 1. Almost clear, Almost no lesions; 2. Mild; 3. Moderate; 4. Severe; 5. Very severe
Effect of the RV3278A on microorganisms	Change from baseline to 2 months	Qualitative analysis by 2 and 3-dimensional electron microscopy from comedones samples
Effect of the RV3278A on lipids	Change from baseline to 2 months	Qualitative analysis by 2 and 3-dimensional electron microscopy from comedones samples
RV3278A product tolerance	From Day 1 to 2 months	Adverse events occurrence will be determined by the subject's / parent(s) or guardian(s) spontaneous reporting, the investigator's non-leading questioning, and his/her clinical evaluation
Effect of the RV3278A on hyperkeratosis	Change from baseline to 2 months	Qualitative analysis by 2 and 3-dimensional electron microscopy from comedones samples

Trial Locations

Locations (2)

Centre de santé SABOURAUD C.E.P.C; 🇫🇷 Paris, France

Centre de Recherche sur la Peau; 🇫🇷 Toulouse, France