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Completed

NCT Number: NCT05640388

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

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

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Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de santé SABOURAUD C.E.P.C, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Related to the population:
  • Subject aged between 12 to 25 years included
  • 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

  • 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
  • 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

Treatment and study plan

RV3278A - ET0943 cosmetic product

Other

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

RV4632A - RY1845 cosmetic product

Other

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

Primary outcomes

  1. Effect of the RV3278A on acne severity

    Time frame: Change from baseline to 2 months

    Global Evaluation Acne (GEA), on a 6-point scale 0: Clear. No lesions

    • Almost clear, Almost no lesions
    • Mild
    • Moderate
    • Severe
    • Very severe

  2. Effect of the RV3278A on inflammatory and retentionnal lesions

    Time frame: Change from baseline to 2 months

    Quantification of inflammatory and retentionnal lesions from image analysis

  3. Effect of the RV3278A on microorganisms

    Time frame: Change from baseline to 2 months, for each group

    Quantitative analysis by ddPCR (droplet digital Polymerase Chain Reaction) from comedones samples

  4. Effect of the RV3278A on microorganisms

    Time frame: Change from baseline to 2 months

    Qualitative analysis by 2 and 3-dimensional electron microscopy from comedones samples

  5. Effect of the RV3278A on metabolites

    Time frame: Change from baseline to 1 month

    Metagenomic analysis on comedones samples

  6. Effect of the RV3278A on lipids

    Time frame: Change from baseline to 2 months

    Lipids PCR (Polymerase Chain Reaction) analysis done by SpiderMass tool from cigarette paper and comedones samples

  7. Effect of the RV3278A on lipids

    Time frame: Change from baseline to 2 months

    Qualitative analysis by 2 and 3-dimensional electron microscopy from comedones samples

  8. Effect of the RV3278A on hyperkeratosis

    Time frame: Change from baseline to 2 months

    Qualitative analysis by 2 and 3-dimensional electron microscopy from comedones samples

  9. RV3278A product tolerance

    Time frame: From Day 1 to 2 months

    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

Sponsors and collaborators

Lead sponsor

Pierre Fabre Dermo Cosmetique

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 7, 2022
Registry last updated
Dec 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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