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

NCT ID: NCT05640388

Last Updated: 2022-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-20

Study Completion Date

2022-01-12

Brief Summary

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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

Detailed Description

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Conditions

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Acne

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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RV3278A arm : Treated group

This group will receive the RV3278A - ET0943 product

RV3278A - ET0943 cosmetic product

Intervention Type OTHER

RV3278A - ET0943 study product is applied twice a day on the face during the whole study.

RV4632A arm : Control group

This group will receive the RV4632A - RY1845 product

RV4632A - RY1845 cosmetic product

Intervention Type OTHER

RV4632A - RY1845 study product must be applied only in case of sensation of skin discomfort

Interventions

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RV3278A - ET0943 cosmetic product

RV3278A - ET0943 study product is applied twice a day on the face during the whole study.

Intervention Type OTHER

RV4632A - RY1845 cosmetic product

RV4632A - RY1845 study product must be applied only in case of sensation of skin discomfort

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pierre Fabre Dermo Cosmetique

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pascal REYGAGNE

Role: PRINCIPAL_INVESTIGATOR

Centre de Santé Sabouraud

Locations

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Centre de santé SABOURAUD C.E.P.C

Paris, , France

Site Status

Centre de Recherche sur la Peau

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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RV3278A20200403

Identifier Type: -

Identifier Source: org_study_id

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