Acne
Conditions
Keywords
Comedones, Lipids, Blackheads, Host/Microorganism Relationship, Micro comedones
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
Interventions
OTHERRV3278A - ET0943 cosmetic product
RV3278A - ET0943 study product is applied twice a day on the face during the whole study.
OTHERRV4632A - RY1845 cosmetic product
RV4632A - RY1845 study product must be applied only in case of sensation of skin discomfort
Sponsors
Pierre Fabre Dermo Cosmetique
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
12 Years to 25 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 1. Almost clear, Almost no lesions 2. Mild 3. Moderate 4. Severe 5. 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 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 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 |
Countries
France
Outcome results
None listed