Cargando…

Safety and effectiveness of hyaluronic acid dermal filler in correction of moderate-to-severe nasolabial folds in Chinese subjects

BACKGROUND: Modified sodium hyaluronate gel for injection, Princess(®) VOLUME (PV), has been on the European market since 2009 to correct deeper wrinkles and folds, increasing or restoring volume of the face, and remodeling facial contours. OBJECTIVE: To evaluate the safety and effectiveness of PV i...

Descripción completa

Detalles Bibliográficos
Autores principales: Dai, Xia, Li, Li, Peterson, Ward, Baumgartner, Renate R, Huang, Jinmei, Baer-Zwick, Alexandra, Hoeller, Sonja, Ivezic-Schoenfeld, Zrinka, Prinz, Martin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6336025/
https://www.ncbi.nlm.nih.gov/pubmed/30666143
http://dx.doi.org/10.2147/CCID.S187079
_version_ 1783388001314799616
author Dai, Xia
Li, Li
Peterson, Ward
Baumgartner, Renate R
Huang, Jinmei
Baer-Zwick, Alexandra
Hoeller, Sonja
Ivezic-Schoenfeld, Zrinka
Prinz, Martin
author_facet Dai, Xia
Li, Li
Peterson, Ward
Baumgartner, Renate R
Huang, Jinmei
Baer-Zwick, Alexandra
Hoeller, Sonja
Ivezic-Schoenfeld, Zrinka
Prinz, Martin
author_sort Dai, Xia
collection PubMed
description BACKGROUND: Modified sodium hyaluronate gel for injection, Princess(®) VOLUME (PV), has been on the European market since 2009 to correct deeper wrinkles and folds, increasing or restoring volume of the face, and remodeling facial contours. OBJECTIVE: To evaluate the safety and effectiveness of PV in correction of moderate-to-severe nasolabial folds (NLF) in Chinese subjects. METHODS: In this prospective, split-face, randomized, evaluator and subject-blinded, multicenter, noninferiority trial, 120 subjects were randomized to bilateral NLF treatment with PV administered in one NLF and Restylane(®) (RL) administered in the other NLF. NLFs were evaluated using the validated 5-point Wrinkle Severity Rating Scale with scores ranging from 1= none (no visible NLF) to 5= very severe (extremely deep and long NLF). Response was defined as ≥1 point improvement at Week 24 assessed by the blinded independent review committee (IRC) and the reduction of NLF severity, assessed by subjects and IRC based on the Global Aesthetic Improvement Scale. RESULTS: Among the 115 subjects who completed the study, median initial and touch-up volumes (mL) were 1.00 for both groups with a maximum dosage per NLF of 2.00 and a minimum of 0.30 for PV and 0.60 for RL. At week 24, the Wrinkle Severity Rating Scale improvement rate, as assessed by the IRC, reached 68.70% for PV and 52.17% for RL. The results indicate that PV is noninferior to RL (p<0.001). Most frequently reported adverse events for both devices were injection site swelling and procedural pain. The severity of the majority of the adverse events was mild. CONCLUSION: This study confirms that PV is a safe and effective treatment for the correction of moderate-to-severe NLFs in Chinese subjects.
format Online
Article
Text
id pubmed-6336025
institution National Center for Biotechnology Information
language English
publishDate 2019
publisher Dove Medical Press
record_format MEDLINE/PubMed
spelling pubmed-63360252019-01-21 Safety and effectiveness of hyaluronic acid dermal filler in correction of moderate-to-severe nasolabial folds in Chinese subjects Dai, Xia Li, Li Peterson, Ward Baumgartner, Renate R Huang, Jinmei Baer-Zwick, Alexandra Hoeller, Sonja Ivezic-Schoenfeld, Zrinka Prinz, Martin Clin Cosmet Investig Dermatol Original Research BACKGROUND: Modified sodium hyaluronate gel for injection, Princess(®) VOLUME (PV), has been on the European market since 2009 to correct deeper wrinkles and folds, increasing or restoring volume of the face, and remodeling facial contours. OBJECTIVE: To evaluate the safety and effectiveness of PV in correction of moderate-to-severe nasolabial folds (NLF) in Chinese subjects. METHODS: In this prospective, split-face, randomized, evaluator and subject-blinded, multicenter, noninferiority trial, 120 subjects were randomized to bilateral NLF treatment with PV administered in one NLF and Restylane(®) (RL) administered in the other NLF. NLFs were evaluated using the validated 5-point Wrinkle Severity Rating Scale with scores ranging from 1= none (no visible NLF) to 5= very severe (extremely deep and long NLF). Response was defined as ≥1 point improvement at Week 24 assessed by the blinded independent review committee (IRC) and the reduction of NLF severity, assessed by subjects and IRC based on the Global Aesthetic Improvement Scale. RESULTS: Among the 115 subjects who completed the study, median initial and touch-up volumes (mL) were 1.00 for both groups with a maximum dosage per NLF of 2.00 and a minimum of 0.30 for PV and 0.60 for RL. At week 24, the Wrinkle Severity Rating Scale improvement rate, as assessed by the IRC, reached 68.70% for PV and 52.17% for RL. The results indicate that PV is noninferior to RL (p<0.001). Most frequently reported adverse events for both devices were injection site swelling and procedural pain. The severity of the majority of the adverse events was mild. CONCLUSION: This study confirms that PV is a safe and effective treatment for the correction of moderate-to-severe NLFs in Chinese subjects. Dove Medical Press 2019-01-14 /pmc/articles/PMC6336025/ /pubmed/30666143 http://dx.doi.org/10.2147/CCID.S187079 Text en © 2019 Dai et al. 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/). 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.
spellingShingle Original Research
Dai, Xia
Li, Li
Peterson, Ward
Baumgartner, Renate R
Huang, Jinmei
Baer-Zwick, Alexandra
Hoeller, Sonja
Ivezic-Schoenfeld, Zrinka
Prinz, Martin
Safety and effectiveness of hyaluronic acid dermal filler in correction of moderate-to-severe nasolabial folds in Chinese subjects
title Safety and effectiveness of hyaluronic acid dermal filler in correction of moderate-to-severe nasolabial folds in Chinese subjects
title_full Safety and effectiveness of hyaluronic acid dermal filler in correction of moderate-to-severe nasolabial folds in Chinese subjects
title_fullStr Safety and effectiveness of hyaluronic acid dermal filler in correction of moderate-to-severe nasolabial folds in Chinese subjects
title_full_unstemmed Safety and effectiveness of hyaluronic acid dermal filler in correction of moderate-to-severe nasolabial folds in Chinese subjects
title_short Safety and effectiveness of hyaluronic acid dermal filler in correction of moderate-to-severe nasolabial folds in Chinese subjects
title_sort safety and effectiveness of hyaluronic acid dermal filler in correction of moderate-to-severe nasolabial folds in chinese subjects
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6336025/
https://www.ncbi.nlm.nih.gov/pubmed/30666143
http://dx.doi.org/10.2147/CCID.S187079
work_keys_str_mv AT daixia safetyandeffectivenessofhyaluronicaciddermalfillerincorrectionofmoderatetoseverenasolabialfoldsinchinesesubjects
AT lili safetyandeffectivenessofhyaluronicaciddermalfillerincorrectionofmoderatetoseverenasolabialfoldsinchinesesubjects
AT petersonward safetyandeffectivenessofhyaluronicaciddermalfillerincorrectionofmoderatetoseverenasolabialfoldsinchinesesubjects
AT baumgartnerrenater safetyandeffectivenessofhyaluronicaciddermalfillerincorrectionofmoderatetoseverenasolabialfoldsinchinesesubjects
AT huangjinmei safetyandeffectivenessofhyaluronicaciddermalfillerincorrectionofmoderatetoseverenasolabialfoldsinchinesesubjects
AT baerzwickalexandra safetyandeffectivenessofhyaluronicaciddermalfillerincorrectionofmoderatetoseverenasolabialfoldsinchinesesubjects
AT hoellersonja safetyandeffectivenessofhyaluronicaciddermalfillerincorrectionofmoderatetoseverenasolabialfoldsinchinesesubjects
AT ivezicschoenfeldzrinka safetyandeffectivenessofhyaluronicaciddermalfillerincorrectionofmoderatetoseverenasolabialfoldsinchinesesubjects
AT prinzmartin safetyandeffectivenessofhyaluronicaciddermalfillerincorrectionofmoderatetoseverenasolabialfoldsinchinesesubjects