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

Pierre Fabre

Status: Completed

Conditions: Acne

Treatments: Other: RV4632A - RY1845 cosmetic product; Other: RV3278A - ET0943 cosmetic product

Study type: Observational

Funder types: Industry

Identifiers

NCT05640388

RV3278A20200403

Details and patient eligibility

About

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

Enrollment: 41 patients

Sex: All

Ages: 12 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

41 participants in 2 patient groups

RV3278A arm : Treated group

Description:

This group will receive the RV3278A - ET0943 product

Treatment:

Other: RV3278A - ET0943 cosmetic product

RV4632A arm : Control group

Description:

This group will receive the RV4632A - RY1845 product

Treatment:

Other: RV4632A - RY1845 cosmetic product