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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RV3278A arm : Treated group | This group will receive the RV3278A - ET0943 product |
| |
| RV4632A arm : Control group | This group will receive the RV4632A - RY1845 product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RV3278A - ET0943 cosmetic product | Other | RV3278A - ET0943 study product is applied twice a day on the face during the whole study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of the RV3278A on acne severity | Global Evaluation Acne (GEA), on a 6-point scale 0: Clear. No lesions
| 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 |
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Inclusion Criteria:
Related to the population:
- Subject aged between 12 to 25 years included
Related to diseases:
Exclusion Criteria:
Related to diseases:
Related to the treatments/products:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pascal REYGAGNE | Centre de Santé Sabouraud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de santé SABOURAUD C.E.P.C | Paris | France | ||||
| Centre de Recherche sur la Peau |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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Sebum and comedones constituents
| RV4632A - RY1845 cosmetic product | Other | RV4632A - RY1845 study product must be applied only in case of sensation of skin discomfort |
|
| 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 |
| Toulouse |
| 31400 |
| France |