NCT04861766

Safety and Effectiveness of STYLAGE® L for Correction of Moderate and Severe Nasolabial Folds in Chinese Adults

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 390 (actual)
• Sponsor: Laboratoires Vivacy · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Aging
• Skin Wrinkling

Interventions

Type	Name	Description
DEVICE	STYLAGE® L	Injection in both NLFs
DEVICE	Active Comparator	Injection in both NLFs

Timeline

• Start date: 2021-05-06
• Primary completion: 2022-08-16
• Completion: 2023-03-31
• First posted: 2021-04-27
• Last updated: 2023-04-19

Locations

8 sites across 1 country: China