Dong Li1, Jiaming Sun2, Sufan Wu3. 1. Peking University Third Hospital, Beijing, China. 2. Union Hospital, Tongji Medical College Huazhong University of Science and Technology, Wuhan, China. 3. Zhejiang Provincial People's Hospital, Hangzhou, China.
Abstract
BACKGROUND: Nonsurgical injectable treatments, including hyaluronic acid (HA) fillers, are increasingly used in Asian patients. AIMS: To demonstrate the efficacy and safety of Restylane Lyft compared to Restylane for the correction of nasolabial folds (NLFs). PATIENTS/ METHODS: This was a randomized, evaluator-blinded, split-face, 12-month study conducted in China using Restylane Lyft in the aesthetic correction of moderate to severe NLFs among adult subjects. One NLF was treated with Restylane Lyft, and the opposite NLF with the comparator Restylane. Efficacy outcomes included improvement in the Wrinkle Severity Rating Scale (WSRS) and aesthetic improvement (using the Global Aesthetic Improvement Scale [GAIS] assessed by the subject and blinded evaluator) for each treatment at Months 3, 6 (primary objective based on WSRS), 9, and 12. Safety was evaluated by the incidence of injection site reactions and adverse events (AEs). RESULTS:A total of 100 subjects were randomized to the treatments. Noninferiority for Restylane Lyft was established according to blinded evaluation of WSRS at 6 months after last treatment. Similarly, the WSRS improved throughout the study, and the responder rate (improvement in WSRS of ≥1 grade from Baseline) was sustained after 6 months (64% and 65% for NLFs treated with Restylane and Restylane Lyft, respectively). For GAIS after 6 months, improvement was approximately 80% in both groups. No treatment-related serious AEs were reported. The safety profiles were similar between the two treatments. CONCLUSIONS: Similar to Restylane, Restylane Lyft was effective and well tolerated for treatment of moderate to severe NLFs in this Chinese population.
RCT Entities:
BACKGROUND: Nonsurgical injectable treatments, including hyaluronic acid (HA) fillers, are increasingly used in Asian patients. AIMS: To demonstrate the efficacy and safety of Restylane Lyft compared to Restylane for the correction of nasolabial folds (NLFs). PATIENTS/ METHODS: This was a randomized, evaluator-blinded, split-face, 12-month study conducted in China using Restylane Lyft in the aesthetic correction of moderate to severe NLFs among adult subjects. One NLF was treated with Restylane Lyft, and the opposite NLF with the comparator Restylane. Efficacy outcomes included improvement in the Wrinkle Severity Rating Scale (WSRS) and aesthetic improvement (using the Global Aesthetic Improvement Scale [GAIS] assessed by the subject and blinded evaluator) for each treatment at Months 3, 6 (primary objective based on WSRS), 9, and 12. Safety was evaluated by the incidence of injection site reactions and adverse events (AEs). RESULTS: A total of 100 subjects were randomized to the treatments. Noninferiority for Restylane Lyft was established according to blinded evaluation of WSRS at 6 months after last treatment. Similarly, the WSRS improved throughout the study, and the responder rate (improvement in WSRS of ≥1 grade from Baseline) was sustained after 6 months (64% and 65% for NLFs treated with Restylane and Restylane Lyft, respectively). For GAIS after 6 months, improvement was approximately 80% in both groups. No treatment-related serious AEs were reported. The safety profiles were similar between the two treatments. CONCLUSIONS: Similar to Restylane, Restylane Lyft was effective and well tolerated for treatment of moderate to severe NLFs in this Chinese population.