Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 9:51 PM
Study NCT ID:
NCT07341659
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-14
First Post:
2025-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Cosmetic Product RV3278B-OS0386 in the Maintenance Phase After Oral Isotretinoin Treatment of Adults Subjects With Facial Acne.
Sponsor:
Pierre Fabre Dermo Cosmetique
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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Visit 6 (month 12): End of study Visit In case of subject's acne relapse confirmed by the investigator, subject will be withdrawn from the study.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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: