Abstract
BACKGROUND: Hyaluronic acid (HA) soft tissue fillers are used to restore volume loss to the lips and perioral area. OBJECTIVE: Evaluate the safety and effectiveness of the HA filler Juvéderm(®) Volbella(®) (VYC-15L) for lip enhancement in Chinese adults. METHODS & MATERIALS: In this multicenter, evaluator-blind study, subjects seeking lip enhancement were randomized 3:1 to VYC-15L or no-treatment control group (with optional treatment delayed by 3 months). Effectiveness endpoints included 1-point improvement on the 5-point Lip Fullness Scale (LFS) assessed by evaluating investigators (EIs) and subjects, and overall volume of lips and change in lip surface area measured from 3-dimensional images. Safety assessments included procedural pain, injection site reactions (ISRs), and adverse events (AEs). RESULTS: The modified intention-to-treat population included 163 subjects (median age, 34 years; 96.9% female). More VYC-15L-treated subjects had a 1-point reduction in EI-reported LFS score at month 3 versus untreated controls (84.7% vs 0%; p < 0.0001), and 65% of the treated subjects self-reported a 1-point LFS improvement at month 3. Procedural pain during injection was mild. The most common ISRs were swelling, tenderness to touch, and firmness. One treatment-related serious AE (injection site compression arterial ischemia) resolved in 16 days. CONCLUSION: VYC-15L treatment was superior to no treatment at 3 months and was well tolerated by subjects. CLINICAL TRIAL REGISTRATION NUMBER: NCT03519204.