Clinical trial NCT05640388: Assessment of a Cosmetic Product Effect on the Host/Microorganism Relationship in Acneic Subjects
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acne
Keywords: Comedones
Lipids
Blackheads
Host/Microorganism Relationship
Micro comedones
Lead sponsor: Pierre Fabre Dermo Cosmetique
Sponsor class: INDUSTRY
First posted: 2022-12-07
Enrollment: 41
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects are enrolled during their usual medical care and/or from the database of the investigational sites.

The subjects corresponding to eligibility criteria may receive a phone call, a letter or an e-mail proposing to participate to the study.

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


Eligibility criteria: 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

Primary outcomes:
measure: Effect of the RV3278A on acne severity
timeFrame: Change from baseline to 2 months
measure: Effect of the RV3278A on inflammatory and retentionnal lesions
timeFrame: Change from baseline to 2 months
measure: Effect of the RV3278A on microorganisms
timeFrame: Change from baseline to 2 months, for each group
measure: Effect of the RV3278A on microorganisms
timeFrame: Change from baseline to 2 months
measure: Effect of the RV3278A on metabolites
timeFrame: Change from baseline to 1 month
measure: Effect of the RV3278A on lipids
timeFrame: Change from baseline to 2 months
measure: Effect of the RV3278A on lipids
timeFrame: Change from baseline to 2 months
measure: Effect of the RV3278A on hyperkeratosis
timeFrame: Change from baseline to 2 months
measure: RV3278A product tolerance
timeFrame: From Day 1 to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre de santé SABOURAUD C.E.P.C
city: Toulouse
country: France
facility: Centre de Recherche sur la Peau
Study officials:
affiliation: Centre de Santé Sabouraud
name: Pascal REYGAGNE
role: PRINCIPAL_INVESTIGATOR
References: