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

Aging Clinical Trial

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

Clinical Trial Summary

This is a safety and efficacy study of STYLAGE® Lin Chinese adults with Nasolabial Folds.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04861766
Study type Interventional
Source Laboratoires Vivacy
Contact
Status Completed
Phase N/A
Start date May 6, 2021
Completion date March 31, 2023
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