Alexander Rivkin, Jeremy B Green, Suzanne Bruce, Sue Ellen Cox, Oscar Hevia, Smita Chawla, Marta Sartor
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引用次数: 0
Abstract
Background: A well-defined jawline improves overall facial aesthetics, motivating patients to seek jawline augmentation.
Objectives: In this study we evaluated the safety and effectiveness of the hyaluronic acid injectable gel VYC-25L for restoring jawline definition.
Methods: In a US multicenter, evaluator-blinded study adults with grade 2 (moderate) or 3 (severe) Allergan Loss of Jawline Definition Scale (ALJDS) scores were randomized. Participants were randomized to the VYC-25L treatment group or control group at study onset, with 12-month follow-up. The control group had the option to receive treatment after 6 months (primary endpoint completion). Effectiveness measures included Month 6 ALJDS responders rate (proportion of participants with ≥1-grade improvement from baseline on both sides), FACE-Q Satisfaction With Lower Face and Jawline scores, and Global Aesthetic Improvement Scale (GAIS) responders (improved/much improved) as assessed by the investigator and participants. Injection site responses (ISRs) and adverse events (AEs) were monitored.
Results: At Month 6, ALJDS responder rates were 69.0% vs 38.0% in the VYC-25L treatment (n = 157) and control (n = 49) groups, respectively (P = .0001). In the VYC-25L treatment group, FACE-Q scores improved by a mean of 45.9 points from baseline at Month 6 (P < .0001). Furthermore, 88.4% and 89.0% of participants in the VYC-25L treatment group were GAIS responders at Month 6 by participant and investigator assessment, respectively. Most ISRs were mild or moderate and resolved within 2 weeks. Most treatment-related AEs were mild and resolved within 1 week.
Conclusions: VYC-25L safely and effectively restores jawline definition through 1 year.
期刊介绍：
Aesthetic Surgery Journal is a peer-reviewed international journal focusing on scientific developments and clinical techniques in aesthetic surgery. The official publication of The Aesthetic Society, ASJ is also the official English-language journal of many major international societies of plastic, aesthetic and reconstructive surgery representing South America, Central America, Europe, Asia, and the Middle East. It is also the official journal of the British Association of Aesthetic Plastic Surgeons, the Canadian Society for Aesthetic Plastic Surgery and The Rhinoplasty Society.
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