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. 2022 Feb 16:15:237-245.
doi: 10.2147/CCID.S344350. eCollection 2022.

Juvéderm Volift (VYC-17.5L), a Hyaluronic Acid Filler with Lidocaine, is Safe and Effective for Correcting Nasolabial Folds in Chinese Subjects

Yun Xie  1 , Qin Li  2 , Zhanwei Gao  3 , Jiaming Sun  4 , Dong Li  5 , Candice Harvey  6 , Jiazhi Qu  7 , Sean Snow  8 , Qingfeng Li  1
Affiliations

Juvéderm Volift (VYC-17.5L), a Hyaluronic Acid Filler with Lidocaine, is Safe and Effective for Correcting Nasolabial Folds in Chinese Subjects

Yun Xie et al. Clin Cosmet Investig Dermatol. .

Abstract

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.

Keywords: dermal fillers; hyaluronic acid; lidocaine.

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Conflict of interest statement

Candice Harvey and Sean Snow are AbbVie employees and may own stock or stock options. Jiazhi Qu was an employee of Allergan plc (prior to its acquisition by AbbVie) at the time the study was conducted. Qingfeng Li, Qin Li, Zhanwei Gao, Jiaming Sun, Dong Li, and Yun Xie report no potential conflicts related to this manuscript.

Figures

Figure 1
Figure 1
Study design. Telephone symbol indicates safety follow-up via phone call.
Figure 2
Figure 2
Subject disposition and reasons for discontinuation. *Primary evaluation timepoint.
Figure 3
Figure 3
Improvement in nasolabial fold severity.
Figure 4
Figure 4
Representative treatment effects: a 49-year-old female subject who received an initial treatment of VYC-17.5L (0.75 mL) in the right NLF and an initial treatment of control product (0.7 mL) in the left NLF.
Figure 5
Figure 5
Representative treatment effects: a 60-year-old female subject who received an initial treatment of VYC-17.5L (0.8 mL) in the right NLF and an initial treatment of control product (0.8 mL) in the left NLF.
Figure 6
Figure 6
Subject preference for overall treatment outcome.
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