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Active, not recruiting Not applicable

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

NCT07341659 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-02-28
Last updated
2026-01-14

Condition(s) studied

Acne

Investigational drug(s) / intervention(s)

Test product RV3278BB-OS0386Control product RV3278B-OS0548

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

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

Study 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.

Eligibility

Sex
ALL
Min age
15 Years
Max age
35 Years
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (5)

FacilityCityRegionStatus
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
Dr. I.Karamon Private Practice Gdansk Poland
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07341659 on ClinicalTrials.gov ↗ ← All trials in Italy