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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group Stylage L ® | Experimental | Each subject will receive STYLAGE® L in both NLFs. STYLAGE® L will be injected in the NLFs by the Treating Investigator with optional touch-up injections on Month 1. |
|
| Control group Active Comparator | Active Comparator | Each subject will receive the Active Comparator in both NLFs. Active Comparator will be injected in the NLFs by the Treating Investigator with optional touch-up injections on Month 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STYLAGE® L | Device | Injection in both NLFs |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| WSRS improvement | Percentage of responders, defined by at least 1-point improvement from baseline 5-point WSRS, as measured by the Blinded Evaluator | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yan Wu | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Beijing | Dong Cheng District | 100730 | China | ||
| SUN YAT-SEN Memorial Hospital, SUN YAT-SEN University |
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A Controlled, Prospective, Randomized, Multi-Center, Subject and Evaluator-Blinded Study
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The identity of individual investigation materials will remain unknown to the independent Blinded Evaluator and all subjects.
| Active Comparator |
| Device |
Injection in both NLFs |
|
| 1, 3, 9, and 12 months |
| Subject satisfaction assessment | Percentage of satisfied subjects on each question of the subject satisfaction assessment | 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. | 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. | Day 0, Month 1, Month 3, Month 6, Month 9, Month 12 |
| Guangzhou |
| Guangdong |
| 510289 |
| China |
| Guangdong Second Provincial General Hospital | Guangzhou | Guangdong | 510317 | China |
| Air Force Medical Center, PLA | Beijing | Haidian District | 100142 | China |
| Peking University Third Hospital | Beijing | Haidian District | 100191 | China |
| West China Hospital of Stomatology Sichuan University | Chengdu | Sichuan | 610041 | China |
| West China Hospital Sichuan University | Chengdu | Sichuan | 610041 | China |
| Peking University First Hospital | Beijing | Xicheng District | 100034 | China |