Clinical, Cosmetic and Investigational Dermatology (Nov 2022)
Safe and Effective Lip Enhancement with VYC-15L in Chinese Adults
Abstract
Dong Li,1 Zhanwei Gao,2 Jiaming Sun,3 Qin Li,4 Ping Jiang,5 Lijuan Zhang,6 Smita Chawla7 1Peking University Third Hospital, Beijing, People’s Republic of China; 2Japan Friendship Hospital, Beijing, People’s Republic of China; 3Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, People’s Republic of China; 4General Hospital of Guangzhou Military Command of PLA, Guangzhou, People’s Republic of China; 5Nanfang Hospital, Southern Medical University, Guangzhou, People’s Republic of China; 6Allergan Aesthetics, an AbbVie Company, Beijing, People’s Republic of China; 7Clinical Development, Allergan Aesthetics, an AbbVie Company, Irvine, CA, USACorrespondence: Smita Chawla, Clinical Development, Allergan Aesthetics, an AbbVie Company, 2525 Dupont Drive, Irvine, CA, 92612, USA, Tel +1 714 246-2213, Email [email protected]: 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.Keywords: dermal fillers, hyaluronic acid, China
