Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433323
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-05-22
Brief Title:
Biological Anti-aging Efficacy of a Cosmetic Night Cream
Sponsor:
Pierre Fabre Dermo Cosmetique
Organization:
Pierre Fabre Dermo Cosmetique
Study Overview
Official Title:
Evaluation of Biological Anti-aging Efficacy of the Cosmetic Night Cream RV4983A- LA3365 in Women After 2 Months of Daily Use
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
In a previous study the cosmetic night cream RV4983A- LA3365 has proven a great efficacy in reducing the clinical signs of skin aging as well as a great tolerance The skin structure and composition greatly evolve over the time and deciphering the biological mechanisms by which the cosmetic night cream RV4983A- LA3365 reduces the signs of skin aging is therefore of great interest to deepen our efficacy evaluation and knowledge on skin aging biology
Detailed Description:
An intra-individual comparative study randomized will be conducted as monocentric trial in female adult
46 subjects are included
4 visits are planned
Visit 1 D1 Inclusion and 1st product application
Visit 2 D28 Phone call follow-up
Visit 3 D57 End of application and biopsies
Visit 4 7 days after V3 Biopsies control and end-of-study
For a subject completing the study the theoretical investigational product application will be 56 consecutive days up to 59 days maximum
The maximal duration of participation for a subject is 68 days
46 subjects are included
4 visits are planned
Visit 1 D1 Inclusion and 1st product application
Visit 2 D28 Phone call follow-up
Visit 3 D57 End of application and biopsies
Visit 4 7 days after V3 Biopsies control and end-of-study
For a subject completing the study the theoretical investigational product application will be 56 consecutive days up to 59 days maximum
The maximal duration of participation for a subject is 68 days
Study Oversight
Has Oversight DMC:
None
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?:
None