Assessment of a Cosmetic Product Effect on the Host/Microorganism Relationship in Acneic Subjects
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- 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 Almost clear, Almost no lesions Mild Moderate Severe Very severe
- 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 microorganisms [Change from baseline to 2 months, for each group]
Quantitative analysis by ddPCR (droplet digital Polymerase Chain Reaction) from comedones samples
- 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 metabolites [Change from baseline to 1 month]
Metagenomic analysis on comedones samples
- Effect of the RV3278A on lipids [Change from baseline to 2 months]
Lipids PCR (Polymerase Chain Reaction) analysis done by SpiderMass tool from cigarette paper and 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
- Effect of the RV3278A on hyperkeratosis [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
Eligibility Criteria
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre de santé SABOURAUD C.E.P.C | Paris | France | ||
| 2 | Centre de Recherche sur la Peau | Toulouse | France | 31400 |
Sponsors and Collaborators
- Pierre Fabre Dermo Cosmetique
Investigators
- Principal Investigator: Pascal REYGAGNE, Centre de Santé Sabouraud
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RV3278A20200403