Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351293
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-20
Brief Title:
A Comparative Analysis of Two Hyaluronic Acid Fillers for Nasolabial Fold Correction
Sponsor:
Galderma RD
Organization:
Galderma RD
Study Overview
Official Title:
A Randomized Split-face Clinical Study on Comparative Analysis of Two Hyaluronic Acid Fillers for Nasolabial Fold Correction
Status:
ACTIVE_NOT_RECRUITING
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:
This is a randomized split-face subject-blinded comparative study Subjects will receive initial treatment with Defyne on one of the NLFs and with RHA3 on the other based on the pre-determined randomization
4 weeks after the initial treatment subjects will receive optional touch-up on one side or both sides at the Investigators discretion for optimal correction
Subjects to return to the site at Month 3 6 and 12 for follow-ups
4 weeks after the initial treatment subjects will receive optional touch-up on one side or both sides at the Investigators discretion for optimal correction
Subjects to return to the site at Month 3 6 and 12 for follow-ups
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None