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An Open-Label Uncontrolled, Multicenter Study for the Evaluation of the Efficacy and Safety of the Dermal Filler Princess VOLUME in the Treatment of Nasolabial Folds

The dermal filler Princess VOLUME is a highly cross-linked, viscoelastic hyaluronic acid injectable gel implant used for aesthetic treatment. To evaluate the efficacy and safety of Princess VOLUME in the treatment of nasolabial folds, an open-label uncontrolled, multicenter study was conducted. Fort...

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Autores principales: Kopera, Daisy, Palatin, Michael, Bartsch, Rolf, Bartsch, Katrin, O'Rourke, Maria, Höller, Sonja, Baumgartner, Renate R., Prinz, Martin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Hindawi Publishing Corporation 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4363551/
https://www.ncbi.nlm.nih.gov/pubmed/25821787
http://dx.doi.org/10.1155/2015/195328
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author Kopera, Daisy
Palatin, Michael
Bartsch, Rolf
Bartsch, Katrin
O'Rourke, Maria
Höller, Sonja
Baumgartner, Renate R.
Prinz, Martin
author_facet Kopera, Daisy
Palatin, Michael
Bartsch, Rolf
Bartsch, Katrin
O'Rourke, Maria
Höller, Sonja
Baumgartner, Renate R.
Prinz, Martin
author_sort Kopera, Daisy
collection PubMed
description The dermal filler Princess VOLUME is a highly cross-linked, viscoelastic hyaluronic acid injectable gel implant used for aesthetic treatment. To evaluate the efficacy and safety of Princess VOLUME in the treatment of nasolabial folds, an open-label uncontrolled, multicenter study was conducted. Forty-eight subjects were recruited who had moderate to deep wrinkles, according to the Modified Fitzpatrick Wrinkle Scale (MFWS). Subjects received Princess VOLUME in both nasolabial folds at Day 0. Nasolabial fold severity was evaluated at 30, 90, 180, and 270 days after treatment, using the MFWS and the Global Aesthetic Improvement Scale (GAIS). Adverse events and treatment site reactions were recorded. Among the 48 subjects, 93.8% were female with a median age of 52 years. There were significant improvements (P < 0.0001) in the MFWS scores at 30, 180, and 270 days after treatment compared with those at baseline, with a mean decrease of 1.484 (±0.408), 1.309 (±0.373), and 1.223 (±0.401), respectively; hence the primary endpoint was achieved and clinical efficacy demonstrated. Princess VOLUME was well tolerated, and most adverse events were injection site reactions of mild to moderate severity. Subject satisfaction (97.9%), subject recommendation of the treatment (93.6%), and investigators GAIS scores (97.9% improvement) were high.
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spelling pubmed-43635512015-03-29 An Open-Label Uncontrolled, Multicenter Study for the Evaluation of the Efficacy and Safety of the Dermal Filler Princess VOLUME in the Treatment of Nasolabial Folds Kopera, Daisy Palatin, Michael Bartsch, Rolf Bartsch, Katrin O'Rourke, Maria Höller, Sonja Baumgartner, Renate R. Prinz, Martin Biomed Res Int Clinical Study The dermal filler Princess VOLUME is a highly cross-linked, viscoelastic hyaluronic acid injectable gel implant used for aesthetic treatment. To evaluate the efficacy and safety of Princess VOLUME in the treatment of nasolabial folds, an open-label uncontrolled, multicenter study was conducted. Forty-eight subjects were recruited who had moderate to deep wrinkles, according to the Modified Fitzpatrick Wrinkle Scale (MFWS). Subjects received Princess VOLUME in both nasolabial folds at Day 0. Nasolabial fold severity was evaluated at 30, 90, 180, and 270 days after treatment, using the MFWS and the Global Aesthetic Improvement Scale (GAIS). Adverse events and treatment site reactions were recorded. Among the 48 subjects, 93.8% were female with a median age of 52 years. There were significant improvements (P < 0.0001) in the MFWS scores at 30, 180, and 270 days after treatment compared with those at baseline, with a mean decrease of 1.484 (±0.408), 1.309 (±0.373), and 1.223 (±0.401), respectively; hence the primary endpoint was achieved and clinical efficacy demonstrated. Princess VOLUME was well tolerated, and most adverse events were injection site reactions of mild to moderate severity. Subject satisfaction (97.9%), subject recommendation of the treatment (93.6%), and investigators GAIS scores (97.9% improvement) were high. Hindawi Publishing Corporation 2015 2015-03-03 /pmc/articles/PMC4363551/ /pubmed/25821787 http://dx.doi.org/10.1155/2015/195328 Text en Copyright © 2015 Daisy Kopera et al. https://creativecommons.org/licenses/by/3.0/ This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Clinical Study
Kopera, Daisy
Palatin, Michael
Bartsch, Rolf
Bartsch, Katrin
O'Rourke, Maria
Höller, Sonja
Baumgartner, Renate R.
Prinz, Martin
An Open-Label Uncontrolled, Multicenter Study for the Evaluation of the Efficacy and Safety of the Dermal Filler Princess VOLUME in the Treatment of Nasolabial Folds
title An Open-Label Uncontrolled, Multicenter Study for the Evaluation of the Efficacy and Safety of the Dermal Filler Princess VOLUME in the Treatment of Nasolabial Folds
title_full An Open-Label Uncontrolled, Multicenter Study for the Evaluation of the Efficacy and Safety of the Dermal Filler Princess VOLUME in the Treatment of Nasolabial Folds
title_fullStr An Open-Label Uncontrolled, Multicenter Study for the Evaluation of the Efficacy and Safety of the Dermal Filler Princess VOLUME in the Treatment of Nasolabial Folds
title_full_unstemmed An Open-Label Uncontrolled, Multicenter Study for the Evaluation of the Efficacy and Safety of the Dermal Filler Princess VOLUME in the Treatment of Nasolabial Folds
title_short An Open-Label Uncontrolled, Multicenter Study for the Evaluation of the Efficacy and Safety of the Dermal Filler Princess VOLUME in the Treatment of Nasolabial Folds
title_sort open-label uncontrolled, multicenter study for the evaluation of the efficacy and safety of the dermal filler princess volume in the treatment of nasolabial folds
topic Clinical Study
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4363551/
https://www.ncbi.nlm.nih.gov/pubmed/25821787
http://dx.doi.org/10.1155/2015/195328
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