The goal of this clinical trial is to evaluate the safety and effectiveness of a poly-L-lactic acid (PLLA) dermal implant for the correction of nasolabial folds. The study also aims to determine whether the investigational product (FUYANMEI Poly-L-Lactic Acid) is non-inferior to the control product (Sculptra).
The main questions it aims to answer are:
* Is the effectiveness rate based on the Wrinkle Severity Rating Scale (WSRS) at 6 months after injection for the investigational group non-inferior to that of the control group? * How does the investigational product perform in terms of global aesthetic improvement as assessed by blinded evaluators and by subjects? * What is the safety profile of the investigational product, including the incidence, severity, and relatedness of adverse events (AEs), serious adverse events (SAEs), and device deficiencies (DDs)?
Researchers will compare the investigational PLLA implant to an approved PLLA implant using a prospective, randomized, evaluator- and subject-blinded, single-center, split-face controlled study design. Approximately 121 eligible participants will be enrolled.
Participants will:
* Receive treatment with the investigational product and the control product according to the split-face design * Be followed for 24 months after injection * Return to the clinic at 1, 3, 6, 12, 18, and 24 months post-injection for follow-up visits * Undergo blinded evaluator assessments of WSRS and Global Aesthetic Improvement Scale (GAIS) * Complete subject self-assessments of GAIS and treatment satisfaction * Be monitored throughout the study for adverse events, serious adverse events, and medical device deficiencies
Willing and able to provide written informed consent prior to any study-specific procedures.
Male or female subjects aged between 19 and 65 years.
Presence of bilateral nasolabial fold wrinkles with a Wrinkle Severity Rating Scale (WSRS) score of moderate (Grade 3) or severe (Grade 4) at baseline.
Willingness and ability to comply with all protocol-required follow-up visits and procedures.
History of hypertrophic scarring or keloid formation.
Presence of active infection or dermatologic conditions at or near the intended injection site that may interfere with the evaluation.
Underwent major surgery within 3 months prior to study initiation.
Diagnosed with autoimmune diseases, malignancies, psychiatric disorders, or poorly controlled chronic medical conditions.
Parallel
FUYANMEI Poly-L-Lactic Acid
DevicePoly-L-Lactic Acid
Sculptra®
DevicePoly-L-Lactic Acid
The responder rate based on the Wrinkle Severity Rating Scale (WSRS).
The WSRS responder rate at Month 6 post-injection was compared between the treatment and control groups. A WSRS responder was defined as a participant who achieved an improvement of at least 1 point in the WSRS score compared with baseline.
Wrinkle Severity Rating Scale (WSRS) scores
WSRS was assessed using a 5-point scale (1-5), with higher scores indicating greater wrinkle severity. Blinded evaluators assessed WSRS scores at baseline, immediately post-treatment (Day 0), and at Months 1, 3, 6, 12, 18, and 24 following injection.
WSRS responder rates
WSRS responder rates assessed by blinded evaluators at baseline, Day 0, and Months 1, 3, 12, 18, and 24 post-injection. A WSRS responder was defined as a participant who achieved an improvement of at least 1 point in the WSRS score compared with baseline.
Change in nasolabial fold volume
Images were captured using a VECTRA H2 3D camera (Canfield Scientific) at a fixed distance from the subject's face under standardized lighting and background conditions. The resulting image files were analyzed for volumetric measurements using 3D imaging software. Changes in nasolabial fold volume from baseline (Day 0) were assessed at Months 1, 3, 6, 12, 18, and 24 using the three-dimensional imaging system.
Global Aesthetic Improvement Scale (GAIS) scores
GAIS scores were measured using a 5-point scale (1-5), with lower scores indicating poorer improvement. Blinded evaluators assessed GAIS scores immediately post-treatment (Day 0) and at Months 1, 3, 6, 12, 18, and 24 after injection.
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