Ignite Creation Date:
2025-12-24 @ 7:54 PM
Ignite Modification Date:
2025-12-25 @ 5:30 PM
Study NCT ID:
NCT05963204
Status:
COMPLETED
Last Update Posted:
2024-10-24
First Post:
2023-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effects for Midface Improvement When Pairing a Biostimulator with a Skincare Regimen
Sponsor:
Galderma R&D
Organization:
Study Overview
Official Title:
A Randomized, Double-blinded, Split-face, Comparative Study to Evaluate the Synergistic Effects for Improving the Aging Midface When Pairing a Biostimulator with a Skincare Regimen
Status:
COMPLETED
Status Verified Date:
2024-10
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:
None
Brief Summary:
To assess skin structural change in midface after treatment with a biostimulator using Line-Field Optical Coherence Tomography
Detailed Description:
This is a randomized, double-blinded, split-face, comparative study.
This study is designed to enroll and randomize approximately 20 subjects. All subjects are to have midface volume loss and contour deficiency and facial photodamage.
Eligible subjects are randomized to receive study skincare products for pre-conditioning, 2 weeks before Baseline. All subjects receive biostimulator treatment at the midface by the Treating Investigator at Baseline. The method of injection is at the discretion of the Treating Investigator. A sufficient amount of product is injected to achieve optimal correction of the midface, in the opinion of the Treating Investigator.
At the 6-week visit, after all study procedures for the visit are completed, treated subjects received a second biostimulator treatment to achieve optimal aesthetic improvement. At the 12-week and 18-week visits, similar study procedures are performed.
This study is designed to enroll and randomize approximately 20 subjects. All subjects are to have midface volume loss and contour deficiency and facial photodamage.
Eligible subjects are randomized to receive study skincare products for pre-conditioning, 2 weeks before Baseline. All subjects receive biostimulator treatment at the midface by the Treating Investigator at Baseline. The method of injection is at the discretion of the Treating Investigator. A sufficient amount of product is injected to achieve optimal correction of the midface, in the opinion of the Treating Investigator.
At the 6-week visit, after all study procedures for the visit are completed, treated subjects received a second biostimulator treatment to achieve optimal aesthetic improvement. At the 12-week and 18-week visits, similar study procedures are performed.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: