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

Acne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05640388
• Other study ID #: RV3278A20200403
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Acne

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