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

Study Overview
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Brief Summary
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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

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

Conditions
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Acne

Intervention / Treatment
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* Other: RV3278A - ET0943 cosmetic product
* Other: RV4632A - RY1845 cosmetic product


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Comedones, Lipids, Blackheads, Host/Microorganism Relationship, Micro comedones