Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-01 @ 8:49 AM
Study NCT ID:
NCT04861766
Status:
COMPLETED
Last Update Posted:
2023-04-19
First Post:
2021-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness of STYLAGE® L for Correction of Moderate and Severe Nasolabial Folds in Chinese Adults
Sponsor:
Laboratoires Vivacy
Organization:
Study Overview
Official Title:
A Controlled, Prospective, Randomized, Multi-Center, Subject and Evaluator-Blinded Study of the Safety and Effectiveness of STYLAGE® L Versus Restylane® for Correction of Moderate and Severe Nasolabial Folds in Chinese Adults
Status:
COMPLETED
Status Verified Date:
2023-04
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:
None
Brief Summary:
This is a safety and efficacy study of STYLAGE® Lin Chinese adults with Nasolabial Folds.
Detailed Description:
This is a prospective, multi-center, parallel-group, subject and evaluator-blinded, randomized controlled trial to demonstrate the non-inferiority of the study device, STYLAGE® L, when compared to an active comparator for the correction of moderate and severe NLFs.
Subjects will randomly receive STYLAGE® L or the active comparator (ratio 1:1) injection in the NLFs at first visit on Day 0.
Proportion of subjects having a NLFs severity improvement (blinded evaluation), 6 months after treatment initiation will be assessed and compared between the two groups. This will also be done during the other visits (1, 3, 9 and 12 months after treatment initiation). Global aesthetic improvement according to blinded independent evaluator and subject, subjects' satisfaction, and safety parameters will also be assessed during the study period.
Subjects will randomly receive STYLAGE® L or the active comparator (ratio 1:1) injection in the NLFs at first visit on Day 0.
Proportion of subjects having a NLFs severity improvement (blinded evaluation), 6 months after treatment initiation will be assessed and compared between the two groups. This will also be done during the other visits (1, 3, 9 and 12 months after treatment initiation). Global aesthetic improvement according to blinded independent evaluator and subject, subjects' satisfaction, and safety parameters will also be assessed during the study period.
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?: