Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07341659
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.
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Visit 6 (month 12): End of study Visit In case of subject's acne relapse confirmed by the investigator, subject will be withdrawn from the study.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.
Study:
NCT07341659
Study Brief:
Protocol Section:
NCT07341659