Efficacy of Cosmetic Product RV3278B-OS0386 on Skin Surface Ecosystem, in Teenagers with Mild to Moderate Facial Acne

NCT06659861 | Completed

• 1 other identifier: RV3278B20240316
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this exploratory study is to better understand the mechanisms of action of the RV3278B-OS0386 cosmetic product on the cutaneous ecosystem, in acne context.

Conditions

Acne

Keywords

Skin ecosystem; cosmetic care product

Outcome Measures

Primary Outcomes (6)

• Effect of the RV3278B on acne severity

  Assessed by the investigator on a 6-point scale (0 to 5 with 0: clear and 5: very severe)

  Change from Visit 1 (Day 1) to Visit 3 (Day 57).

• Effect of the RV3278B on open comedones.

  Quantification of open comedones

  Change from Visit 1 (Day 1) to Visit 3 (Day 57).

• Effect of the RV3278B on biological criteria within isolated comedones

  Analyses of comedone composition

  Change from Visit 1 (Day 1) to Visit 3 (Day 57).

• Effect of the RV3278B on biological criteria from the skin surface

  Analyses of skin microbiota

  Change from Visit 1 (Day 1) to Visit 3 (Day 57).

• Effect of the RV3278B on biometrological criteria

  Skin potential hydrogen measurement by pH meter

  Change from Visit 1 (Day 1) to Visit 3 (Day 57).

• Adverse events related to RV3278B

  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 Visit 1 (Day 1) to Visit 3 (Day 57)

Secondary Outcomes (1)

• Illustrative Outcome : Standardized photographs of the subject's face

  Visit 1 (Day 1) to Visit 3 (Day 57).

Study Arms (2)

Test Group

EXPERIMENTAL

This group will apply the RV3278B-OS0386 cosmetic product for acne prone skin.

Other: RV3278B-OS0386

Control Group

OTHER

This group will receive the associated cosmetic product RV4632A-RY1845 (emollient cream), to be applied in the event of facial skin discomfort only.

Other: RV4632A-RY1845

Interventions

RV3278B-OS0386 OTHER

Cosmetic product to be applied twice a day on the face during the whole study

Test Group

RV4632A-RY1845 OTHER

Cosmetic product to be applied in the event of facial skin discomfort only

Control Group

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Criteria related to the population:
• Female and male aged between 12 and 17 years included
• Subject having signed his/her written informed consent/assent for his/her participation in the study
• Subject whose parent(s) or guardian(s) has (have) given his/her (their) written consent for their child's participation in the study
• Subject affiliated to a social security system or health insurance, or is a beneficiary
• Subject whose parent(s) or guardian(s) is (are) registered with health social security or health insurance
• Subject and/or parents certifying the truth of the personal information declared to the investigator
• Cooperative subject and/or parent(s)/legal representative(s), aware of the necessity and duration of controls so that perfect adhesion to the protocol established by the clinical trial centre could be expected
• Subject with phototype I, II, III, IV according to the Fitzpatrick scale
• For woman/girl of childbearing potential:
• accept to go on using it during the whole duration of the study
• Criteria related to the skin condition (acne):
• Subject with combination, combination to greasy skin tendency or oily skin on face
• Subject with mild to moderate acne vulgaris on face; GEA from 2 to 3
• Subject with predominantly non-inflammatory acne on the forehead

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Cidp Romania

Bucharest, 011607, Romania

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 26, 2024
• Study Start: October 10, 2024
• Primary Completion: March 6, 2025
• Study Completion: March 6, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)