单位:[1]Plastic Surgery Department of Shanghai 9th People's Hospital, Shanghai, People's Republic of China.[2]Plastic Surgery Department of General Hospital of Guangzhou Military Command of PLA, Guangzhou, Guangdong, People's Republic of China.[3]Plastic Surgery Department of Japan Friendship Hospital, Chaoyang, Beijing, People's Republic of China.[4]Plastic Surgery Department of Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, People's Republic of China.华中科技大学同济医学院附属协和医院[5]Plastic Surgery Department of Peking University Third Hospital, Haidian, Beijing, People's Republic of China.[6]Allergan Aesthetics, an AbbVie Company, Marlow, UK.[7]Allergan Aesthetics, an AbbVie Company, Beijing, People's Republic of China.[8]Allergan Aesthetics, an AbbVie Company, Irvine, CA, USA.
Purpose: Hyaluronic acid injectable gels are commonly used to treat nasolabial folds (NLFs). We evaluated the safety and effectiveness of VYC-17.5L for correcting NLFs in Chinese subjects. Patients and Methods: This prospective, multicenter, double-blind, within-subject-controlled study randomized adults with moderate-to-severe NLFs to VYC-17.5L treatment (initial and touch-up) in 1 NLF and control (without lidocaine) in the contralateral NLF. Effectiveness endpoints at 6 months included noninferiority of VYC-17.5L to control in NLF Severity Scale response rate (primary endpoint), subject-reported procedural pain (11-point scale), and investigator and subject assessments using the Global Aesthetic Improvement Scale (GAIS). Results: A total of 175 subjects were included. The primary endpoint was met, with response rates of 84.2% for VYC-17.5L and 82.5% for control. Mean pain scores after initial and touch-up treatments were 2.4 for VYC-17.5L versus 5.2 for control (P < 0.001) and 2.0 versus 3.3 (P < 0.001), respectively. Investigator-rated GAIS scores were 86.5% for VYC-17.5L versus 86.0% for control. There were no between-group differences in subject-rated GAIS scores. Safety profiles were comparable for VYC-17.5L and control. Conclusion: VYC-17.5L was noninferior to control without lidocaine for correcting moderate-to-severe NLFs in Chinese subjects and was superior to control in reducing procedural pain.
基金:
Allergan Aesthetics, an AbbVie Company, Irvine, CA; Allergan Aesthetics, an AbbVie company
第一作者单位:[1]Plastic Surgery Department of Shanghai 9th People's Hospital, Shanghai, People's Republic of China.
通讯作者:
通讯机构:[1]Plastic Surgery Department of Shanghai 9th People's Hospital, Shanghai, People's Republic of China.[*1]Shanghai 9th People’s Hospital, No. 639, Zizaoju Road, Shanghai, 200011, People’s Republic of China
推荐引用方式(GB/T 7714):
Xie Yun,Li Qin,Gao Zhanwei,et al.Juvederm Volift (VYC-17.5L), a Hyaluronic Acid Filler with Lidocaine, is Safe and Effective for Correcting Nasolabial Folds in Chinese Subjects[J].CLINICAL COSMETIC and INVESTIGATIONAL DERMATOLOGY.2022,15:237-245.doi:10.2147/CCID.S344350.
APA:
Xie Yun,Li Qin,Gao Zhanwei,Sun Jiaming,Li Dong...&Li Qingfeng.(2022).Juvederm Volift (VYC-17.5L), a Hyaluronic Acid Filler with Lidocaine, is Safe and Effective for Correcting Nasolabial Folds in Chinese Subjects.CLINICAL COSMETIC and INVESTIGATIONAL DERMATOLOGY,15,
MLA:
Xie Yun,et al."Juvederm Volift (VYC-17.5L), a Hyaluronic Acid Filler with Lidocaine, is Safe and Effective for Correcting Nasolabial Folds in Chinese Subjects".CLINICAL COSMETIC and INVESTIGATIONAL DERMATOLOGY 15.(2022):237-245