"Safe and Effective Lip Enhancement with VYC-15L in Chinese Adults" Featured in Clinical, Cosmetic and Investigational Dermatology
Hyaluronic acid (HA) soft tissue fillers are used to restore volume loss to the lips and perioral area.
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).
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.
VYC-15L treatment was superior to no treatment at 3 months and was well tolerated by subjects.