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Safe and Effective Lip Enhancement with VYC-15L in Chinese Adults

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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 [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
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关键词: dermal fillers hyaluronic acid China

摘要:
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.

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出版当年[2021]版:
大类 | 4 区 医学
小类 | 4 区 皮肤病学
最新[2025]版:
大类 | 4 区 医学
小类 | 4 区 皮肤病学
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出版当年[2020]版:
Q3 DERMATOLOGY
最新[2023]版:
Q3 DERMATOLOGY

影响因子: 最新[2023版] 最新五年平均[2021-2025] 出版当年[2020版] 出版当年五年平均[2016-2020] 出版前一年[2019版] 出版后一年[2021版]

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第一作者单位: [1]Peking University Third Hospital, Beijing, People’s Republic of China
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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,
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