Abstract
BACKGROUND: A randomized study previously reported demonstration of the safety and efficacy of hyaluronic acid filler VYC-25L for restoring jawline definition. OBJECTIVES: The aim of this study was to evaluate patient-reported outcomes (PROs), objective changes in jawline profile, and safety and effectiveness measures by Fitzpatrick skin phototype (FST), gender, and age following VYC-25L treatment. METHODS: Adults were randomized to receive VYC-25L (n = 157) or no treatment (control; n = 49) for 6 months. PROs were assessed by FACE-Q Satisfaction with Lower Face and Jawline, FACE-Q Appraisal of Lines: Marionette, and participant satisfaction with treatment questionnaires. Changes in jawline profile linear depth and volume were calculated with 3-dimensional digital image analysis. Responder rates, PROs, and injection site responses (ISRs) were assessed by FST, gender, and age. RESULTS: At Month 6, >70% of treated participants responded "somewhat/very satisfied" to FACE-Q Satisfaction with Lower Face and Jawline questions, and ≥78% of treated participants responded "satisfied/definitely satisfied" with treatment overall. For participants treated for the marionette lines, the FACE-Q Appraisal of Lines: Marionette questionnaire mean score improved by 32.6 (baseline to Month 6). Mean change in linear depth in the prejowl sulcus in the treatment vs control groups was 4.6 mm vs 2.5 mm, respectively, and for jawline volume was 6.0 mL and -2.6 mL, respectively (baseline to Month 6). Subanalyses showed similar outcomes by FST, gender, and age, except for a numerically higher ISR incidence in females vs males. CONCLUSIONS: Treatment with VYC-25L to improve jawline definition yielded high patient satisfaction, objective improvements in jawline profile, and comparable effectiveness across various demographics.