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

A Randomized Investigator-blinded Comparative Study to Assess the Efficacy of the Cosmetic Care Product RV4133C - Formula JT2559 in Subjects With Facial Acne, During a 3-month-associated-treatment Phase Followed by a 3-month-maintenance Phase

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.

Study Overview

• Status: Recruiting
• Conditions: Acne
• Intervention / Treatment: Other: Test product; Other: Comparator product

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adeline Bacquey; Phone Number: +33562877753; Email: adeline.bacquey@pierre-fabre.com
• Study Contact Backup: Name: Christophe Chamard; Phone Number: +33562488566; Email: christophe.chamard@pierre-fabre.com

Study Locations

• Brazil
  • São Paulo, Brazil, 04024-002
    • Recruiting
    • UNIFESP
    • Contact: Edileia BAGATIN, MD,PhD; Phone Number: +55 11 5579-2581; Email: nucleodepesquisa@huhsp.org.br
    • Principal Investigator: Edileia BAGATIN, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Group	Other: Test product; Twice daily applications, in association of a reference medical treatment during a 3-month-associated-treatment phase, then alone during a 3-month-maintenance phase. The product is applied to the entire face.
Placebo Comparator: Comparative group	Other: Comparator product; Twice daily applications, in association of a reference medical treatment during a 3-month-associated-treatment phase, then alone during a 3-month-maintenance phase. The product is applied to the entire face.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of number of total acne lesions on the face	Number of total acne lesions by counting according to the Lucky method performed by the investigator	Assessment after 24 weeks of use

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator's global assessment (IGA)	Assessed by the investigator on the face on a 5-point scale ranged from 0 (clear) to 4 (severe)	Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Acne lesions counting	Number of all type of acne lesions by counting according to subject's photographs analysis using acne Artificial Intelligence	Assessment at baseline and 1 week, 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Acne QoL questionnaire	Assessed by the subject via a specific questionnaire of 19 questions	Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Subject's Global change Assessment (SGA)	Assessed by the subject via a 7-point scale: SGA of acne severity	Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Post-Inflammatory Hyperpigmentation (PIH) lesions counting	Number of PIH lesions by counting according to the Lucky method performed by the investigator	Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Post-Inflammatory Erythema (PIE) lesions counting	Number of PIE lesions by counting according to the Lucky method performed by the investigator	Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Subject's Global change Assessment (SGA) of post inflammatory lesions	Assessed by the subject via a 7-point scale: SGA of post inflammatory lesions (PIH and PIE)	Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Acne worsening/ relapse	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	Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Time to relapse	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).	Assessment after 4 weeks and 12 weeks of use, without reference medical treatment
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	The subject will report his/her compliance in a subject's diary	Through study completion, 6 months
Cosmetic satisfaction as regards to the use of the test product RV4133C by Cosmetic acceptability questionnaire assessed by the patient	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).	Assessed after 4 weeks of use

Collaborators and Investigators

• Sponsor: Pierre Fabre Dermo Cosmetique

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2024
• Primary Completion (Estimated): July 30, 2025
• Study Completion (Estimated): July 30, 2025

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: November 29, 2024
• First Posted (Estimated): December 4, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: November 29, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: young adults; maintenance; acne; teenagers; face; treatment phase
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: RV4133C20230380

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No