A Comparative Study of Cosmetic Product in Subjects With Facial Acne During an Associated-treatment Phase Followed by a Maintenance Phase

Not Applicable

Recruiting

• Conditions: Acne

• Registration Number: NCT06716398
• Lead Sponsor: Pierre Fabre Dermo Cosmetique

Brief Summary

In this study, we are interested in the global benefit of the tested product as complementary care to a topical medical treatment during a 3 month-associated treatment phase followed by a 3 month-maintenance phase, compared to a light moisturizing cream, in teenagers and adults with acne. We also want to evaluate the tolerance of the tested product in association and in maintenance of the topical medical treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-03
• Status Verified: 2024-11
• Study First Submitted: 2024-11-29
• Study First Submitted QC: 2024-11-29
• Last Update Submitted: 2024-11-29
• Study First Posted: 2024-12-04
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-07-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Male or Female aged between 14 and 24 years (included)
• Subject with facial acne with score index severity IGA = 2 or 3, assessed on a scale ranged from 0 to 4.
• Subject for whom a prescription of 12 weeks of a reference topical medical treatment is required from the day of the inclusion visit, for mild to moderate face acne

Exclusion Criteria

Criteria related to the disease:

• Facial skin disease other than acne, skin abnormalities, or dermatological condition on the face liable to interfere with the study assessments
• Acne conglobata, Acne fulminans, nodulocystic acne or acneiform eruptions, according to investigator's assessment
• Other type of pigmentation disorder than acne-related PIH liable to interfere with the study assessments according to the investigator

Criteria related to treatments and/or products:

• Topical or oral treatment established or modified during the previous weeks or planned to be established or modified during the study, liable to interfere with the evaluation of the efficacy or cutaneous tolerance of the investigational products

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessment of number of total acne lesions on the face	Assessment after 24 weeks of use	Number of total acne lesions by counting according to the Lucky method performed by the investigator

Secondary Outcome Measures

Name	Time	Method
Investigator's global assessment (IGA)	Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use	Assessed by the investigator on the face on a 5-point scale ranged from 0 (clear) to 4 (severe)
Acne lesions counting	Assessment at baseline and 1 week, 4 weeks, 12 weeks, 16 weeks and 24 weeks of use	Number of all type of acne lesions by counting according to subject's photographs analysis using acne Artificial Intelligence
Acne QoL questionnaire	Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use	Assessed by the subject via a specific questionnaire of 19 questions
Subject's Global change Assessment (SGA)	Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use	Assessed by the subject via a 7-point scale: SGA of acne severity
Post-Inflammatory Hyperpigmentation (PIH) lesions counting	Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use	Number of PIH lesions by counting according to the Lucky method performed by the investigator
Post-Inflammatory Erythema (PIE) lesions counting	Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use	Number of PIE lesions by counting according to the Lucky method performed by the investigator
Time to relapse	Assessment after 4 weeks and 12 weeks of use, without reference medical treatment	The time to first acne relapse will be calculated from the date of Visit 3 (start of maintenance phase) to the date of failure (acne relapse).
Subject's Global change Assessment (SGA) of post inflammatory lesions	Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use	Assessed by the subject via a 7-point scale: SGA of post inflammatory lesions (PIH and PIE)
Acne worsening/ relapse	Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use	Number and percentage of acne worsening/ relapse, defined by the investigator by the necessity to change the topical medical treatment and/ or to introduce an oral medical treatment for facial acne
Global tolerance assessed by the investigator on a 5-point scale	Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Compliance of the subjects to the product RV4133C	Through study completion, 6 months	The subject will report his/her compliance in a subject's diary
Cosmetic satisfaction as regards to the use of the test product RV4133C by Cosmetic acceptability questionnaire assessed by the patient	Assessed after 4 weeks of use	A questionnaire with a scale from 0 to 10 responding to statements about the effect of the product (0=not at all agree, 10=completely agree).

Trial Locations

Locations (1)

UNIFESP; 🇧🇷 São Paulo, Brazil