VYC-25L Hyaluronic Acid Injectable Gel is Safe and Effective for Long-Term Restoration and Creation of Volume of the Lower Face

BACKGROUND: Juvederm Volux (VYC-25L; Allergan plc) is an injectable hyaluronic acid gel designed to restore and create facial volume. OBJECTIVE: Evaluate 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 single repeat treatment during months 18-24. 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. 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.