Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT06770127
Status:
COMPLETED
Last Update Posted:
2025-01-13
First Post:
2025-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of La Roche Posay Routine in the Management of Facial Post Inflammatory Hyperpigmentation (PIHP)
Sponsor:
Cosmetique Active International
Organization:
Study Overview
Official Title:
Efficacy of La Roche Posay Routine in the Management of Facial Post Inflammatory Hyperpigmentation (PIHP)
Status:
COMPLETED
Status Verified Date:
2023-10
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:
PIHP
Brief Summary:
The goal of this clinical trial is to test and compare La Roche Posay routine --the studied product-- with a comparator product in participants with acne. The main question it aims to answer is how well can the product de-pigment the skin.
The participants will be asked to use the products given twice daily. Researchers will compare the routine La Roche Posay group(experimental) with the routine Eucine group(control) to see if the La Roche product shows superiority in case of better efficacy.
The participants will be asked to use the products given twice daily. Researchers will compare the routine La Roche Posay group(experimental) with the routine Eucine group(control) to see if the La Roche product shows superiority in case of better efficacy.
Detailed Description:
The sample size of this study is 80 participants; 40 subjects testing Niacinamide A serum and UV Mune and 40 subjects testing Eucerin Thiamidol anti-pigment serum and Eucerin SPF 50+. The secondary objectives are:
* the effect on the cutaneous acceptability by clinical examination under dermatological control
* the effect of the product on acne lesions is assessed by comparing the number of elements on the face before application and after product use
* the effect on acne severity according to the Global Acne Evaluation
* the mean darkness of the post-inflammatory hyper-pigmentation (PIHP) lesions. A statistical analysis of the following will be done: a comparison of the before/after application, a comparison of the values obtained from the comparison product/comparator product, and a comparison PIHP lesion/normal zone.
The study endpoints are:
* global acne evaluation scale
* mean size, intensity, number of PIHP lesion
* mean darkness of lesions
* subject global assessment score
* improvement in scores in a stigmatization questionnaire
* satisfaction questionnaire
* the effect on the cutaneous acceptability by clinical examination under dermatological control
* the effect of the product on acne lesions is assessed by comparing the number of elements on the face before application and after product use
* the effect on acne severity according to the Global Acne Evaluation
* the mean darkness of the post-inflammatory hyper-pigmentation (PIHP) lesions. A statistical analysis of the following will be done: a comparison of the before/after application, a comparison of the values obtained from the comparison product/comparator product, and a comparison PIHP lesion/normal zone.
The study endpoints are:
* global acne evaluation scale
* mean size, intensity, number of PIHP lesion
* mean darkness of lesions
* subject global assessment score
* improvement in scores in a stigmatization questionnaire
* satisfaction questionnaire
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?: