An Exploratory, Comparative and Multicentric Study, to Evaluate the Effect of the RV3278A - ET0943 on the Host/Micro-organism Relationships in Acneic Subjects
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acne
- Sponsor
- Pierre Fabre Dermo Cosmetique
- Enrollment
- 41
- Locations
- 2
- Primary Endpoint
- Effect of the RV3278A on inflammatory and retentionnal lesions
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Effect of the RV3278A on inflammatory and retentionnal lesions
Time Frame: Change from baseline to 2 months
Quantification of inflammatory and retentionnal lesions from image analysis
Effect of the RV3278A on metabolites
Time Frame: Change from baseline to 1 month
Metagenomic analysis on comedones samples
Effect of the RV3278A on acne severity
Time Frame: 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 microorganisms
Time Frame: Change from baseline to 2 months
Qualitative analysis by 2 and 3-dimensional electron microscopy from comedones samples
Effect of the RV3278A on lipids
Time Frame: Change from baseline to 2 months
Qualitative analysis by 2 and 3-dimensional electron microscopy from comedones samples
RV3278A product tolerance
Time Frame: 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
Effect of the RV3278A on hyperkeratosis
Time Frame: Change from baseline to 2 months
Qualitative analysis by 2 and 3-dimensional electron microscopy from comedones samples