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

NCT07341659 | Active Not Recruiting

• 1 other identifier: RV3278B20240495
• Study Type: interventional
• Target: 102
• Locations: 3 countries
• Sites: 5

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.

Conditions

Acne

Keywords

Acne

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Acne severity by investigator

  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

  From Visit 1 (Day 1) to Visit 6 (Month 12 or early termination)

• Acne lesions count

  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

  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

  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.

Study Arms (2)

Test Group

EXPERIMENTAL

This group will apply the test cosmetic product

Other: Test product RV3278BB-OS0386

Control Group

PLACEBO COMPARATOR

This group will apply the control cosmetic product

Other: Control product RV3278B-OS0548

Interventions

Control product RV3278B-OS0548 OTHER

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

Control Group

Test product RV3278BB-OS0386 OTHER

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

Test Group

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (5)

Centre de santé Sabouraud

Paris, 75010, France

Location

Humanitas Research Hospital - Unita dermatologica

Milan, 20089, Italy

Location

Istituto Dermopatico dell'Immacolata in Roma

Roma, 00167, Italy

Location

Dr. E.Karamon Private Practice

Malbork, Poland, 82200, Poland

Location

Dr. I.Karamon Private Practice

Gdansk, 80280, Poland

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 14, 2026
• Study Start: February 28, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

PL (2); FR (1); IT (2)