Efficacy of Cosmetic Product RV3278B-OS0386 in the Maintenance Phase After Oral Isotretinoin Treatment of Adults Subjects With Facial Acne.

A Multicentric, Randomized, Blinded, Comparative Study to Evaluate the Efficacy of the Cosmetic Product RV3278B-OS0386 in the Maintenance Phase After Oral Isotretinoin Treatment of Adult Subjects With Facial Acne.

The aim of this study is to evaluate the efficacy of the RV3278B-OS0386 cosmetic product, compared to the control product in managing acne relapse during the 12-month maintenance phase follow-up after oral isotretinoin treatment in adult subjects with facial acne.

Study Overview

• Status: Active, not recruiting
• Conditions: Acne
• Intervention / Treatment: Other: Test product RV3278BB-OS0386; Other: Control product RV3278B-OS0548

Detailed Description

This study is conducted as a multicentric, randomized, blinded, comparative study in Europe.

A total number of 102 subjects included and randomized in 2 parallel groups:

• Test group: twice daily application of the RV3278B-OS0386 cosmetic product on the whole face
• Control group: twice daily application of the RV3278B-OS0548 cosmetic product on the whole face

Subjects will be followed at regular intervals for up to 12 months or until the relapse of their acne on the face, whichever occurs first.

6 visits are planned:

• Visit 1 (Day 1): Inclusion, Randomization and start of product
• Visit 2 (month 1)
• Visit 3 (month 3)
• Visit 4 (month 6)
• Visit 5 (month 9)
• Visit 6 (month 12): End of study Visit In case of subject's acne relapse confirmed by the investigator, subject will be withdrawn from the study.

As part of an ancillary exploratory assessment, outcome measures will also be evaluated on augmented datasets including both study subject's data and synthetic data generated from the study subject's data by artificial intelligence.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75010
    • Centre de Sante Sabouraud
• Italy
  • Milan, Italy, 20089
    • Humanitas Research Hospital - Unita dermatologica
  • Roma, Italy, 00167
    • Istituto Dermopatico dell'Immacolata in Roma
• Poland
  • Gdansk, Poland, 80280
    • Dr. I.Karamon Private Practice
  • Poland
    • Malbork, Poland, Poland, 82200
      • Dr. E.Karamon Private Practice

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Male or Female aged between 15 and 35 years included
• Subject affiliated to a social security system or health insurance, or is a beneficiary if applicable
• Subject who recently completed his/her first course of oral isotretinoin treatment
• Subject with clear or almost clear facial acne

Non Inclusion criteria:

• Subject who, in the judgement of the investigator, is not likely to be compliant with study-related constraints and requirements
• Facial skin disease other than acne, skin abnormalities, or dermatological condition on the face liable to interfere with the study assessments
• Severe or complicated cases of acne (ex: acne conglobate) according to investigator's assessment
• Any acute, chronic or progressive disease or medical history liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
• Any surgery, chemical (e.g.: skin peel) or physical treatment on the face done within 12 months before the inclusion or planned during the study
• Topical or systemic product or 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 product according to the investigator's assessment

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Group; This group will apply the test cosmetic product	Other: Test product RV3278BB-OS0386; Cosmetic product RV3278BB-OS0386 to be applied twice a day on the face during the whole study
Placebo Comparator: Control Group; This group will apply the control cosmetic product	Other: Control product RV3278B-OS0548; Cosmetic product RV3278B-OS0548 to be applied twice a day on the face during the whole study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acne relapse rate	The acne relapse rate is defined as percentage of subjects experiencing acne relapse on the face according to the investigator	From Visit 1 (Day 1) to Visit 6 (Month 12 or early termination )

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acne severity by investigator	Acne severity will be assessed by the investigator on the face using a 6-point scale (0 to 5 with 0: clear and 5: very severe)	Visit 1 (Day 1),Visit 2 (Month 1), Visit 3 (Month 3), Visit 4 (Month 6), Visit 5 (Month 9) and Visit 6 (Month 12 or early termination).
Time to acne relapse	Time to acne relapse will be calculated from the date of the visit 1 until the date of the acne relapse as assessed by the investigator.	From Visit 1 (Day 1) to Visit 6 (Month 12 or early termination)
Acne lesions count	Assessed by the investigator according to the Lucky Method by counting papules, pustules, open and closed comedones on the face	Visit 1 (Day 1), Visit 2 (Month 1), Visit 3 (Month 3), Visit 4 (Month 6), Visit 5 (Month 9) and Visit 6 (Month 12 or early termination).
Post-inflammatory lesions count	Assessed by the investigator by counting post-inflammatory hyperpigmentation and erythema lesions on the face	Visit 1 (Day 1), Visit 2 (Month 1), Visit 3 (Month 3), Visit 4 (Month 6), Visit 5 (Month 9) and Visit 6 (Month 12 or early termination).
Acne severity by subject	Acne severity will be assessed by the subject on the face using a 7-point scale (-3 to 3 with -3: much worse and 3: much improved)	Visit 1 (Day 1), Visit 2 (Month 1), Visit 3 (Month 3), Visit 4 (Month 6), Visit 5 (Month 9) and Visit 6 (Month 12 or early termination), and monthly at home.
Quality of life questionnaire	Quality of life will be assessed by the subject by completing the Cardiff Acne Disability Index Questionnaire consisting in 5 questions, each response is on a 4-point scale.	Visit 1 (Day 1), Visit 3 (Month 3) and Visit 6 (Month 12 or early termination).
Adverse events	Adverse events occurrence will be determined by the subject or 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 6 ( Month 12 or early termination)
Global Tolerance	Global Tolerance will be assessed by the investigator with 5-point scale (from 0: bad to 5: excellent)	Visit 3 (Month 3) and Visit 6 (Month 12 or early termination).
Acceptability Questionnaire assessment	Acceptability questionnaire regarding the use of the product will be completed by the subject.	Visit 4 (Month 6) and Visit 6 (Month 12 or early termination).
Standardized photographs of the subject's face for illustrative purpose only	for illustrative purpose only	Visit 1 (Day 1), Visit 4 (Month 6), and Visit 6 (Month 12 or early termination).
Transepidermal water loss	Transepidermal water loss measurement by Tewameter.	Visit 1 (Day 1), Visit 2 (Month 1), Visit 3 (Month 3), Visit 4 (Month 6), Visit 5 (Month 9) and Visit 6 (Month 12 or early termination).
Skin potential hydrogen	Skin potential hydrogen measurement by pH meter.	Visit 1 (Day 1), Visit 2 (Month 1), Visit 3 (Month 3), Visit 4 (Month 6), Visit 5 (Month 9) and Visit 6 (Month 12 or early termination).

Collaborators and Investigators

• Sponsor: Pierre Fabre Dermo Cosmetique

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 14, 2026

Study Record Updates

• Last Update Posted (Actual): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Acne
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Skin and Connective Tissue Diseases; Acne Vulgaris
• Other Study ID Numbers: RV3278B20240495

Drug and device information, study documents

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