单位:[1]Peking University Third Hospital, Beijing, People’s Republic of China[2]Japan Friendship Hospital, Beijing, People’s Republic of China[3]Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, People’s Republic of China华中科技大学同济医学院附属协和医院[4]General Hospital of Guangzhou Military Command of PLA, Guangzhou, People’s Republic of China[5]Nanfang Hospital, Southern Medical University, Guangzhou, People’s Republic of China[6]Allergan Aesthetics, an AbbVie Company, Beijing, People’s Republic of China[7]Clinical Development, Allergan Aesthetics, an AbbVie Company, Irvine, CA, USA
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 Juvederm (R) Volbella (R) (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.
第一作者单位:[1]Peking University Third Hospital, Beijing, People’s Republic of China
通讯作者:
通讯机构:[7]Clinical Development, Allergan Aesthetics, an AbbVie Company, Irvine, CA, USA[*1]Clinical Development, Allergan Aesthetics, an AbbVie Company, 2525 Dupont Drive, Irvine, CA, 92612, USA,
推荐引用方式(GB/T 7714):
Li Dong,Gao Zhanwei,Sun Jiaming,et al.Safe and Effective Lip Enhancement with VYC-15L in Chinese Adults[J].CLINICAL COSMETIC AND INVESTIGATIONAL DERMATOLOGY.2022,15:2427-2436.doi:10.2147/CCID.S382194.
APA:
Li, Dong,Gao, Zhanwei,Sun, Jiaming,Li, Qin,Jiang, Ping...&Chawla, Smita.(2022).Safe and Effective Lip Enhancement with VYC-15L in Chinese Adults.CLINICAL COSMETIC AND INVESTIGATIONAL DERMATOLOGY,15,
MLA:
Li, Dong,et al."Safe and Effective Lip Enhancement with VYC-15L in Chinese Adults".CLINICAL COSMETIC AND INVESTIGATIONAL DERMATOLOGY 15.(2022):2427-2436