Efficacy of Cosmetic Product RV3278B-OS0386 in the Maintenance Phase After Oral Isotretinoin Treatment of Adults Subjects With Facial Acne.
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About
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.
Full 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Visit 6 (month 12): End of study Visit In case of subject's acne relapse confirmed by the investigator, subject will be withdrawn from the study.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.
Enrollment
Sex
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Volunteers
Inclusion and exclusion 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
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
102 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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