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

NCT ID: NCT07341659

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2026-09-30

Brief Summary

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.

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Visit 6 (month 12): End of study Visit In case of subject's acne relapse confirmed by the investigator, subject will be withdrawn from the study.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.

Conditions

Acne

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Test Group

This group will apply the test cosmetic product

Group Type: EXPERIMENTAL

Test product RV3278BB-OS0386

Intervention Type: OTHER

Cosmetic product RV3278BB-OS0386 to be applied twice a day on the face during the whole study

Control Group

This group will apply the control cosmetic product

Group Type: PLACEBO_COMPARATOR

Control product RV3278B-OS0548

Intervention Type: OTHER

Cosmetic product RV3278B-OS0548 to be applied twice a day on the face during the whole study

Interventions

Test product RV3278BB-OS0386

Cosmetic product RV3278BB-OS0386 to be applied twice a day on the face during the whole study

Intervention Type: OTHER

Control product RV3278B-OS0548

Cosmetic product RV3278B-OS0548 to be applied twice a day on the face during the whole study

Intervention Type: OTHER

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pierre Fabre Dermo Cosmetique

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre de santé Sabouraud

Paris, , France

Humanitas Research Hospital - Unita dermatologica

Milan, , Italy

Istituto Dermopatico dell'Immacolata in Roma

Roma, , Italy

Dr. E.Karamon Private Practice

Malbork, Poland, Poland

Dr. I.Karamon Private Practice

Gdansk, , Poland

Countries

France; Italy; Poland

Other Identifiers

RV3278B20240495

Identifier Type: -

Identifier Source: org_study_id