NCT07341659

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.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Pierre Fabre Dermo Cosmetique · Industry
• Sex: All
• Age: 15 Years – 35 Years
• Healthy volunteers: Not accepted

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6 (month 12): End of study Visit In case of subject's acne relapse confirmed by the investigator, subject will be withdrawn from the study.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

Interventions

Type	Name	Description
OTHER	Test product RV3278BB-OS0386	Cosmetic product RV3278BB-OS0386 to be applied twice a day on the face during the whole study
OTHER	Control product RV3278B-OS0548	Cosmetic product RV3278B-OS0548 to be applied twice a day on the face during the whole study

Timeline

• Start date: 2025-02-28
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2026-01-14
• Last updated: 2026-01-14

Locations

5 sites across 3 countries: France, Italy, Poland