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

An Exploratory, Comparative and Multicentric Study, to Evaluate the Effect of the RV3278A - ET0943 on the Host/Micro-organism Relationships in Acneic Subjects

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

Study Overview

• Status: Completed
• Conditions: Acne
• Intervention / Treatment: Other: RV3278A - ET0943 cosmetic product; Other: RV4632A - RY1845 cosmetic product

• Study Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Centre de santé SABOURAUD C.E.P.C
  • Toulouse, France, 31400
    • Centre de Recherche sur la Peau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects are enrolled during their usual medical care and/or from the database of the investigational sites.

The subjects corresponding to eligibility criteria may receive a phone call, a letter or an e-mail proposing to participate to the study.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RV3278A arm : Treated group; This group will receive the RV3278A - ET0943 product	Other: RV3278A - ET0943 cosmetic product; RV3278A - ET0943 study product is applied twice a day on the face during the whole study.
RV4632A arm : Control group; This group will receive the RV4632A - RY1845 product	Other: RV4632A - RY1845 cosmetic product; RV4632A - RY1845 study product must be applied only in case of sensation of skin discomfort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of the RV3278A on acne severity	Global Evaluation Acne (GEA), on a 6-point scale 0: Clear. No lesions; Almost clear, Almost no lesions; Mild; Moderate; Severe; Very severe	Change from baseline to 2 months
Effect of the RV3278A on inflammatory and retentionnal lesions	Quantification of inflammatory and retentionnal lesions from image analysis	Change from baseline to 2 months
Effect of the RV3278A on microorganisms	Quantitative analysis by ddPCR (droplet digital Polymerase Chain Reaction) from comedones samples	Change from baseline to 2 months, for each group
Effect of the RV3278A on microorganisms	Qualitative analysis by 2 and 3-dimensional electron microscopy from comedones samples	Change from baseline to 2 months
Effect of the RV3278A on metabolites	Metagenomic analysis on comedones samples	Change from baseline to 1 month
Effect of the RV3278A on lipids	Lipids PCR (Polymerase Chain Reaction) analysis done by SpiderMass tool from cigarette paper and comedones samples	Change from baseline to 2 months
Effect of the RV3278A on lipids	Qualitative analysis by 2 and 3-dimensional electron microscopy from comedones samples	Change from baseline to 2 months
Effect of the RV3278A on hyperkeratosis	Qualitative analysis by 2 and 3-dimensional electron microscopy from comedones samples	Change from baseline to 2 months
RV3278A product tolerance	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	From Day 1 to 2 months

Collaborators and Investigators

• Sponsor: Pierre Fabre Dermo Cosmetique
• Investigators: Principal Investigator: Pascal REYGAGNE, Centre de Sante Sabouraud

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2021
• Primary Completion (Actual): January 12, 2022
• Study Completion (Actual): January 12, 2022

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Estimate): December 7, 2022

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Lipids; Comedones; Blackheads; Host/Microorganism Relationship; Micro comedones
• Other Study ID Numbers: RV3278A20200403

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No