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A Prospective, Open-Label, Observational, Postmarket Study Evaluating VYC-17.5L for the Correction of Moderate to Severe Nasolabial Folds Over 12 Months

BACKGROUND: VYC-17.5L (17.5 mg/mL hyaluronic acid, 0.3% lidocaine) is a dermal filler intended for deep dermis injection for the treatment of skin depressions. OBJECTIVE: To evaluate 12-month effectiveness and safety of VYC-17.5L for the treatment of moderate/severe nasolabial folds (NLFs). METHODS:...

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Autores principales: Sattler, Gerhard, Philipp-Dormston, Wolfgang G., Van Den Elzen, Helga, Van Der Walt, Cornelius, Nathan, Myooran, Kolodziejczyk, Julia, Kerson, Graeme, Dhillon, Benjeev
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5414733/
https://www.ncbi.nlm.nih.gov/pubmed/28165349
http://dx.doi.org/10.1097/DSS.0000000000000939
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author Sattler, Gerhard
Philipp-Dormston, Wolfgang G.
Van Den Elzen, Helga
Van Der Walt, Cornelius
Nathan, Myooran
Kolodziejczyk, Julia
Kerson, Graeme
Dhillon, Benjeev
author_facet Sattler, Gerhard
Philipp-Dormston, Wolfgang G.
Van Den Elzen, Helga
Van Der Walt, Cornelius
Nathan, Myooran
Kolodziejczyk, Julia
Kerson, Graeme
Dhillon, Benjeev
author_sort Sattler, Gerhard
collection PubMed
description BACKGROUND: VYC-17.5L (17.5 mg/mL hyaluronic acid, 0.3% lidocaine) is a dermal filler intended for deep dermis injection for the treatment of skin depressions. OBJECTIVE: To evaluate 12-month effectiveness and safety of VYC-17.5L for the treatment of moderate/severe nasolabial folds (NLFs). METHODS: Subjects ≥18 years old with moderate/severe NLFs were recruited (N = 70). Injected volume was aimed at achieving optimum correction; top-up treatment was given at 2 weeks if needed. The primary endpoint was investigator-assessed change in NLF severity over 12 months using the validated photonumeric NLF Severity Scale. Secondary endpoints included investigator- and subject-assessed satisfaction and safety. Adverse events judged to be more severe or prolonged than routinely observed were recorded. RESULTS: Sixty-five subjects completed study requirements. Mean volume injected was 3.0 ± 1.0 mL for both NLFs combined. Significant improvement was maintained in investigator-assessed NLF severity at 12 months, and investigators and subjects reported high satisfaction with VYC-17.5L throughout the study. Two unexpected adverse events were reported: (1) redness, swelling, and decreased sensitivity (resolved after 4 days) and (2) swelling (resolved after 48 hours); neither event was serious or life threatening. CONCLUSION: VYC-17.5L is effective and well tolerated for the treatment of moderate to severe NLFs for 1 year.
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spelling pubmed-54147332017-05-10 A Prospective, Open-Label, Observational, Postmarket Study Evaluating VYC-17.5L for the Correction of Moderate to Severe Nasolabial Folds Over 12 Months Sattler, Gerhard Philipp-Dormston, Wolfgang G. Van Den Elzen, Helga Van Der Walt, Cornelius Nathan, Myooran Kolodziejczyk, Julia Kerson, Graeme Dhillon, Benjeev Dermatol Surg Original Article BACKGROUND: VYC-17.5L (17.5 mg/mL hyaluronic acid, 0.3% lidocaine) is a dermal filler intended for deep dermis injection for the treatment of skin depressions. OBJECTIVE: To evaluate 12-month effectiveness and safety of VYC-17.5L for the treatment of moderate/severe nasolabial folds (NLFs). METHODS: Subjects ≥18 years old with moderate/severe NLFs were recruited (N = 70). Injected volume was aimed at achieving optimum correction; top-up treatment was given at 2 weeks if needed. The primary endpoint was investigator-assessed change in NLF severity over 12 months using the validated photonumeric NLF Severity Scale. Secondary endpoints included investigator- and subject-assessed satisfaction and safety. Adverse events judged to be more severe or prolonged than routinely observed were recorded. RESULTS: Sixty-five subjects completed study requirements. Mean volume injected was 3.0 ± 1.0 mL for both NLFs combined. Significant improvement was maintained in investigator-assessed NLF severity at 12 months, and investigators and subjects reported high satisfaction with VYC-17.5L throughout the study. Two unexpected adverse events were reported: (1) redness, swelling, and decreased sensitivity (resolved after 4 days) and (2) swelling (resolved after 48 hours); neither event was serious or life threatening. CONCLUSION: VYC-17.5L is effective and well tolerated for the treatment of moderate to severe NLFs for 1 year. Lippincott Williams & Wilkins 2017-02 2016-10-10 /pmc/articles/PMC5414733/ /pubmed/28165349 http://dx.doi.org/10.1097/DSS.0000000000000939 Text en © 2016 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0) (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
spellingShingle Original Article
Sattler, Gerhard
Philipp-Dormston, Wolfgang G.
Van Den Elzen, Helga
Van Der Walt, Cornelius
Nathan, Myooran
Kolodziejczyk, Julia
Kerson, Graeme
Dhillon, Benjeev
A Prospective, Open-Label, Observational, Postmarket Study Evaluating VYC-17.5L for the Correction of Moderate to Severe Nasolabial Folds Over 12 Months
title A Prospective, Open-Label, Observational, Postmarket Study Evaluating VYC-17.5L for the Correction of Moderate to Severe Nasolabial Folds Over 12 Months
title_full A Prospective, Open-Label, Observational, Postmarket Study Evaluating VYC-17.5L for the Correction of Moderate to Severe Nasolabial Folds Over 12 Months
title_fullStr A Prospective, Open-Label, Observational, Postmarket Study Evaluating VYC-17.5L for the Correction of Moderate to Severe Nasolabial Folds Over 12 Months
title_full_unstemmed A Prospective, Open-Label, Observational, Postmarket Study Evaluating VYC-17.5L for the Correction of Moderate to Severe Nasolabial Folds Over 12 Months
title_short A Prospective, Open-Label, Observational, Postmarket Study Evaluating VYC-17.5L for the Correction of Moderate to Severe Nasolabial Folds Over 12 Months
title_sort prospective, open-label, observational, postmarket study evaluating vyc-17.5l for the correction of moderate to severe nasolabial folds over 12 months
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5414733/
https://www.ncbi.nlm.nih.gov/pubmed/28165349
http://dx.doi.org/10.1097/DSS.0000000000000939
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