Efficacy of Cosmetic Product RV3278B-OS0386 in the Maintenance Phase After Oral Isotretinoin Trea… (NCT07341659) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Efficacy of Cosmetic Product RV3278B-OS0386 in the Maintenance Phase After Oral Isotretinoin Treatment of Adults Subjects With Facial Acne.
France, Italy, Poland102 participantsStarted 2025-02-28
Plain-language 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.
Who can participate
Age range15 Years – 35 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Acne relapse rate
Timeframe: From Visit 1 (Day 1) to Visit 6 (Month 12 or early termination )