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

NCT05640388 | Completed

• 1 other identifier: RV3278A20200403
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 2

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

Conditions

Acne

Keywords

Comedones; Lipids; Blackheads; Host/Microorganism Relationship; Micro comedones

Outcome Measures

Primary Outcomes (9)

• Effect of the RV3278A on acne severity

  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

  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

Study Arms (2)

RV3278A arm : Treated group

This group will receive the RV3278A - ET0943 product

Other: RV3278A - ET0943 cosmetic product

RV4632A arm : Control group

This group will receive the RV4632A - RY1845 product

Other: RV4632A - RY1845 cosmetic product

Interventions

RV3278A - ET0943 cosmetic product OTHER

RV3278A - ET0943 study product is applied twice a day on the face during the whole study.

RV3278A arm : Treated group

RV4632A - RY1845 cosmetic product OTHER

RV4632A - RY1845 study product must be applied only in case of sensation of skin discomfort

RV4632A arm : Control group

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Related to the population:
• \- Subject aged between 12 to 25 years included
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (2)

Centre de santé SABOURAUD C.E.P.C

Paris, France

Location

Centre de Recherche sur la Peau

Toulouse, 31400, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sebum and comedones constituents

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Pascal REYGAGNE

  Centre de Santé Sabouraud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 7, 2022
• Study Start: September 20, 2021
• Primary Completion: January 12, 2022
• Study Completion: January 12, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-11

Locations

FR (2)