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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05640388
Other study ID # RV3278A20200403
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 20, 2021
Est. completion date January 12, 2022

Study information

Verified date November 2022
Source Pierre Fabre Dermo Cosmetique
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date January 12, 2022
Est. primary completion date January 12, 2022
Accepts healthy volunteers No
Gender All
Age group 12 Years to 25 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
RV3278A - ET0943 cosmetic product
RV3278A - ET0943 study product is applied twice a day on the face during the whole study.
RV4632A - RY1845 cosmetic product
RV4632A - RY1845 study product must be applied only in case of sensation of skin discomfort

Locations

Country Name City State
France Centre de santé SABOURAUD C.E.P.C Paris
France Centre de Recherche sur la Peau Toulouse

Sponsors (1)

Lead Sponsor Collaborator
Pierre Fabre Dermo Cosmetique

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Effect of the RV3278A on inflammatory and retentionnal lesions Quantification of inflammatory and retentionnal lesions from image analysis Change from baseline to 2 months
Primary 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
Primary Effect of the RV3278A on microorganisms Qualitative analysis by 2 and 3-dimensional electron microscopy from comedones samples Change from baseline to 2 months
Primary Effect of the RV3278A on metabolites Metagenomic analysis on comedones samples Change from baseline to 1 month
Primary 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
Primary Effect of the RV3278A on lipids Qualitative analysis by 2 and 3-dimensional electron microscopy from comedones samples Change from baseline to 2 months
Primary Effect of the RV3278A on hyperkeratosis Qualitative analysis by 2 and 3-dimensional electron microscopy from comedones samples Change from baseline to 2 months
Primary 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
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