Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-01 @ 10:41 AM
Study NCT ID:
NCT06945393
Status:
COMPLETED
Last Update Posted:
2025-04-25
First Post:
2025-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ANTIPIGMENTING OR DEPIMENTING EFFICACY UNDER PART OF VISIBLE LIGHT
Sponsor:
L'Oreal
Organization:
Study Overview
Official Title:
EVALUATION OF THE EFFICACY OF ANTIPIGMENTING OR DEPIMENTING AGENTS UNDER PART OF VISIBLE LIGHT [400-450NM] EXPOSURES
Status:
COMPLETED
Status Verified Date:
2025-04
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:
ACR_BIOVI_21-0
Brief Summary:
The study intends to validate a protocol and define a positive reference to evaluate the efficacy of anti-pigmenting and depigmenting agents under part of visible Light exposures, between 400nm to 450nm.
It is carried out on cosmetic products for which the safety has been assured by a toxicologist, with the aim of confirming the efficacy of the products, which will be used by a large number of consumers under normal and reasonably foreseeable use conditions.
It is carried out on cosmetic products for which the safety has been assured by a toxicologist, with the aim of confirming the efficacy of the products, which will be used by a large number of consumers under normal and reasonably foreseeable use conditions.
Detailed Description:
The main objective of this study is to assess the efficacy of antipigmenting or depigmenting agents under \[400-450nm\] exposure in healthy volunteers by skin colorimetry (Delta E).
The secondary objectives are:
* To assess the efficacy of antipigmenting or depigmenting agents under \[400-450nm\] exposure in healthy volunteers by clinical evaluation and additional colorimetry measurements (Delta L\*, a\*, b\* and ITA°) and clinical evaluation.
* To assess the local tolerance and safety of the topical formulations under \[400-450nm\] exposure by recording adverse events and safety.
The secondary objectives are:
* To assess the efficacy of antipigmenting or depigmenting agents under \[400-450nm\] exposure in healthy volunteers by clinical evaluation and additional colorimetry measurements (Delta L\*, a\*, b\* and ITA°) and clinical evaluation.
* To assess the local tolerance and safety of the topical formulations under \[400-450nm\] exposure by recording adverse events and safety.
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?: