This is a safety and efficacy study of STYLAGE® Lin Chinese adults with Nasolabial Folds.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
390
Injection in both NLFs
Injection in both NLFs
Beijing Hospital
Beijing, Dong Cheng District, China
SUN YAT-SEN Memorial Hospital, SUN YAT-SEN University
Guangzhou, Guangdong, China
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, China
Air Force Medical Center, PLA
WSRS improvement
Percentage of responders, defined by at least 1-point improvement from baseline 5-point WSRS, as measured by the Blinded Evaluator at 6 months after last treatment for both groups.
Time frame: Month 6
WSRS improvement
Percentage of responders, defined by at least 1-point improvement from baseline 5-point WSRS, as measured by the Blinded Evaluator
Time frame: 1, 3, 9, and 12 months
GAIS assessment
Percentage of responders, defined by having "Improved", "Much improved" or "Very much improved" according to the Global Aesthetic Improvement Scale (GAIS), as assessed by the subject and the Treating Investigator
Time frame: 1, 3, 9, and 12 months
Subject satisfaction assessment
Percentage of satisfied subjects on each question of the subject satisfaction assessment
Time frame: 1, 3, 6, 9, and 12 month
Device performance
Results of device performance evaluation after the initial and touch-up injection, respectively, by the Treating Investigator for both groups.
Time frame: initial and touch up
Report of Adverse Event
Product safety will be assessed by collection of local tolerability after each injection session, and Adverse Events (AEs) throughout the study.
Time frame: Day 0, Month 1, Month 3, Month 6, Month 9, Month 12
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Beijing, Haidian District, China
Peking University Third Hospital
Beijing, Haidian District, China
West China Hospital of Stomatology Sichuan University
Chengdu, Sichuan, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
Peking University First Hospital
Beijing, Xicheng District, China