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Juvéderm Volift (VYC-17.5L), a Hyaluronic Acid Filler with Lidocaine, is Safe and Effective for Correcting Nasolabial Folds in Chinese Subjects
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 a...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Dove
2022
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8859541/ https://www.ncbi.nlm.nih.gov/pubmed/35210801 http://dx.doi.org/10.2147/CCID.S344350 |
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author | Xie, Yun Li, Qin Gao, Zhanwei Sun, Jiaming Li, Dong Harvey, Candice Qu, Jiazhi Snow, Sean Li, Qingfeng |
author_facet | Xie, Yun Li, Qin Gao, Zhanwei Sun, Jiaming Li, Dong Harvey, Candice Qu, Jiazhi Snow, Sean Li, Qingfeng |
author_sort | Xie, Yun |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-8859541 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Dove |
record_format | MEDLINE/PubMed |
spelling | pubmed-88595412022-02-23 Juvéderm Volift (VYC-17.5L), a Hyaluronic Acid Filler with Lidocaine, is Safe and Effective for Correcting Nasolabial Folds in Chinese Subjects Xie, Yun Li, Qin Gao, Zhanwei Sun, Jiaming Li, Dong Harvey, Candice Qu, Jiazhi Snow, Sean Li, Qingfeng Clin Cosmet Investig Dermatol Original Research 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. Dove 2022-02-16 /pmc/articles/PMC8859541/ /pubmed/35210801 http://dx.doi.org/10.2147/CCID.S344350 Text en © 2022 Xie et al. https://creativecommons.org/licenses/by-nc/3.0/This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/ (https://creativecommons.org/licenses/by-nc/3.0/) ). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). |
spellingShingle | Original Research Xie, Yun Li, Qin Gao, Zhanwei Sun, Jiaming Li, Dong Harvey, Candice Qu, Jiazhi Snow, Sean Li, Qingfeng Juvéderm Volift (VYC-17.5L), a Hyaluronic Acid Filler with Lidocaine, is Safe and Effective for Correcting Nasolabial Folds in Chinese Subjects |
title | Juvéderm Volift (VYC-17.5L), a Hyaluronic Acid Filler with Lidocaine, is Safe and Effective for Correcting Nasolabial Folds in Chinese Subjects |
title_full | Juvéderm Volift (VYC-17.5L), a Hyaluronic Acid Filler with Lidocaine, is Safe and Effective for Correcting Nasolabial Folds in Chinese Subjects |
title_fullStr | Juvéderm Volift (VYC-17.5L), a Hyaluronic Acid Filler with Lidocaine, is Safe and Effective for Correcting Nasolabial Folds in Chinese Subjects |
title_full_unstemmed | Juvéderm Volift (VYC-17.5L), a Hyaluronic Acid Filler with Lidocaine, is Safe and Effective for Correcting Nasolabial Folds in Chinese Subjects |
title_short | Juvéderm Volift (VYC-17.5L), a Hyaluronic Acid Filler with Lidocaine, is Safe and Effective for Correcting Nasolabial Folds in Chinese Subjects |
title_sort | juvéderm volift (vyc-17.5l), a hyaluronic acid filler with lidocaine, is safe and effective for correcting nasolabial folds in chinese subjects |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8859541/ https://www.ncbi.nlm.nih.gov/pubmed/35210801 http://dx.doi.org/10.2147/CCID.S344350 |
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