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.