Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-24 @ 12:22 PM
Study NCT ID:
NCT06659861
Status:
COMPLETED
Last Update Posted:
2025-03-17
First Post:
2024-10-21
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Cosmetic Product RV3278B-OS0386 on Skin Surface Ecosystem, in Teenagers with Mild to Moderate Facial Acne
Sponsor:
Pierre Fabre Dermo Cosmetique
Organization:
Study Overview
Official Title:
An Exploratory Randomized Comparative Study to Evaluate the Effect of RV3278B-OS0386 on Skin Ecosystem, in Teenagers with Mild to Moderate Facial Acne
Status:
COMPLETED
Status Verified Date:
2025-03
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 exploratory study is to better understand the mechanisms of action of the RV3278B-OS0386 cosmetic product on the cutaneous ecosystem, in acne context.
Detailed Description:
This study will be conducted as an exploratory monocentric, randomized, comparative study.
A total number of 52 subjects (teenagers with mild to moderate facial acne) will be included and randomized in two parallel groups :
* The tested group who will apply the tested product RV3278B-OS0386
* The control group who will not apply the tested product. However, they will receive the associated product (RV4632A-RY1845), to be applied in the event of facial skin discomfort only.
3 visits are planned:
* Visit 1 (Day 1) : Inclusion, randomization, collection of biological samples on the forehead and start of product application.
* Visit 2 (Day 29 +/- 3 days) : Phone call follow-up
* Visit 3 (Day 57, a window of + 3 days is allowed): End-of-study visit - Collection of biological samples on the forehead.
A total number of 52 subjects (teenagers with mild to moderate facial acne) will be included and randomized in two parallel groups :
* The tested group who will apply the tested product RV3278B-OS0386
* The control group who will not apply the tested product. However, they will receive the associated product (RV4632A-RY1845), to be applied in the event of facial skin discomfort only.
3 visits are planned:
* Visit 1 (Day 1) : Inclusion, randomization, collection of biological samples on the forehead and start of product application.
* Visit 2 (Day 29 +/- 3 days) : Phone call follow-up
* Visit 3 (Day 57, a window of + 3 days is allowed): End-of-study visit - Collection of biological samples on the forehead.
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?:
False
Is an FDA AA801 Violation?: