Vyc-25l Hyaluronic Acid Injectable Gel Is Safe And Effective For Long-Term Restoration And Creation Of Volume Of The Lower Face

AESTHETIC SURGERY JOURNAL(2020)

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摘要
Background: Juvederm Volux (VYC-25L; Allergan plc) is an injectable hyaluronic acid gel designed to restore and create facial volume.Objectives: The aim of this study was to evaluate the safety and effectiveness of Volux for chin retrusion over 18 months and after repeat treatment.Methods: This prospective, single-blind, controlled study enrolled subjects aged >= 18 years with chin retrusion (glabella-subnasale-pogonion facial angle 145 degrees-165 degrees). Subjects were randomized (3:1) to Volux at study onset or 3 months later (control group), and could receive a single repeat treatment during months 18 to 24. Assessments included mean facial-angle change from baseline, Global Aesthetic Improvement Scale (GAIS) responder rates (improved/much improved), improvements in 3 subject-reported FACE-Q scales, and safety.Results: Of 132 enrolled subjects, 119 received initial Volux treatment and 89 received repeat treatment. Mean changes (95% confidence interval) in glabella-subnasale-pogonion angle from baseline for treatment and control groups, respectively, were: 1.15 degrees (0.75 degrees, 1.56 degrees) and 1.16 degrees (0.57 degrees, 1.75 degrees) at month 18, and 3.14 degrees (2.68 degrees, 3.61 degrees) and 2.72 degrees (1.78 degrees, 3.66 degrees) 1 month after repeat treatment. Investigators rated 52.5%/60.0% of treated/control subjects at month 18 and 96.9%/100% after retreatment as GAIS responders; subject-reported rates were 62.0%/64.0% and 93.8%/100%. Durable improvements in Satisfaction with Chin, Satisfaction with Lower Face and Jawline, and Psychological Well-Being were reported in 82.1%, 78.2%, and 60.3% of subjects, respectively, at month 18, and 92.3%, 93.8%, and 67.7% of subjects after retreatment. The safety profile was as expected.Conclusions: Volux injectable gel is a safe, effective, and durable alternative to surgical treatments for increasing chin projection and jaw volume, and results in high patient satisfaction.
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lower face,long-term
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