Cargando…
Safety and performance of cohesive polydensified matrix hyaluronic acid fillers with lidocaine in the clinical setting – an open-label, multicenter study
Cohesive polydensified matrix (CPM(®)) hyaluronic acid fillers are now available with or without lidocaine. The aim of this study was to investigate the safety and performance of CPM(®) fillers with lidocaine in the clinical setting. In an open-label, prospective, postmarketing study, 108 patients f...
Autores principales: | , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove Medical Press
2016
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5076541/ https://www.ncbi.nlm.nih.gov/pubmed/27799807 http://dx.doi.org/10.2147/CCID.S115256 |
_version_ | 1782462040052334592 |
---|---|
author | Kühne, Ulrich Esmann, Jørgen von Heimburg, Dennis Imhof, Matthias Weissenberger, Petra Sattler, Gerhard |
author_facet | Kühne, Ulrich Esmann, Jørgen von Heimburg, Dennis Imhof, Matthias Weissenberger, Petra Sattler, Gerhard |
author_sort | Kühne, Ulrich |
collection | PubMed |
description | Cohesive polydensified matrix (CPM(®)) hyaluronic acid fillers are now available with or without lidocaine. The aim of this study was to investigate the safety and performance of CPM(®) fillers with lidocaine in the clinical setting. In an open-label, prospective, postmarketing study, 108 patients from seven sites in Germany and Denmark were treated with one or more lidocaine-containing CPM(®) fillers. Performance was assessed using the Merz Aesthetics Scales(®) (MAS). Pain was rated on an 11-point visual analog scale. Patients’ and physicians’ satisfaction as well as adverse events were recorded. Improvements of ≥1-point on MAS immediately after and 17 days posttreatment were observed in ~90% of patients compared with baseline. All investigators assessed ejection force, product positioning, and performance as similar or superior to the respective nonlidocaine products. Overall, 94% of investigators were satisfied with the esthetic outcomes and were willing to continue using the products. All patients except one were satisfied with the results, and all were willing to repeat the treatment. Mean pain scores were low during (<3.0) and after injection (<0.6). Except for one case of bruising, all adverse events were mild to moderate. CPM(®) fillers with lidocaine are safe and effective for a wide range of esthetic facial indications. |
format | Online Article Text |
id | pubmed-5076541 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Dove Medical Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-50765412016-10-31 Safety and performance of cohesive polydensified matrix hyaluronic acid fillers with lidocaine in the clinical setting – an open-label, multicenter study Kühne, Ulrich Esmann, Jørgen von Heimburg, Dennis Imhof, Matthias Weissenberger, Petra Sattler, Gerhard Clin Cosmet Investig Dermatol Original Research Cohesive polydensified matrix (CPM(®)) hyaluronic acid fillers are now available with or without lidocaine. The aim of this study was to investigate the safety and performance of CPM(®) fillers with lidocaine in the clinical setting. In an open-label, prospective, postmarketing study, 108 patients from seven sites in Germany and Denmark were treated with one or more lidocaine-containing CPM(®) fillers. Performance was assessed using the Merz Aesthetics Scales(®) (MAS). Pain was rated on an 11-point visual analog scale. Patients’ and physicians’ satisfaction as well as adverse events were recorded. Improvements of ≥1-point on MAS immediately after and 17 days posttreatment were observed in ~90% of patients compared with baseline. All investigators assessed ejection force, product positioning, and performance as similar or superior to the respective nonlidocaine products. Overall, 94% of investigators were satisfied with the esthetic outcomes and were willing to continue using the products. All patients except one were satisfied with the results, and all were willing to repeat the treatment. Mean pain scores were low during (<3.0) and after injection (<0.6). Except for one case of bruising, all adverse events were mild to moderate. CPM(®) fillers with lidocaine are safe and effective for a wide range of esthetic facial indications. Dove Medical Press 2016-10-20 /pmc/articles/PMC5076541/ /pubmed/27799807 http://dx.doi.org/10.2147/CCID.S115256 Text en © 2016 Kühne 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 Kühne, Ulrich Esmann, Jørgen von Heimburg, Dennis Imhof, Matthias Weissenberger, Petra Sattler, Gerhard Safety and performance of cohesive polydensified matrix hyaluronic acid fillers with lidocaine in the clinical setting – an open-label, multicenter study |
title | Safety and performance of cohesive polydensified matrix hyaluronic acid fillers with lidocaine in the clinical setting – an open-label, multicenter study |
title_full | Safety and performance of cohesive polydensified matrix hyaluronic acid fillers with lidocaine in the clinical setting – an open-label, multicenter study |
title_fullStr | Safety and performance of cohesive polydensified matrix hyaluronic acid fillers with lidocaine in the clinical setting – an open-label, multicenter study |
title_full_unstemmed | Safety and performance of cohesive polydensified matrix hyaluronic acid fillers with lidocaine in the clinical setting – an open-label, multicenter study |
title_short | Safety and performance of cohesive polydensified matrix hyaluronic acid fillers with lidocaine in the clinical setting – an open-label, multicenter study |
title_sort | safety and performance of cohesive polydensified matrix hyaluronic acid fillers with lidocaine in the clinical setting – an open-label, multicenter study |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5076541/ https://www.ncbi.nlm.nih.gov/pubmed/27799807 http://dx.doi.org/10.2147/CCID.S115256 |
work_keys_str_mv | AT kuhneulrich safetyandperformanceofcohesivepolydensifiedmatrixhyaluronicacidfillerswithlidocaineintheclinicalsettinganopenlabelmulticenterstudy AT esmannjørgen safetyandperformanceofcohesivepolydensifiedmatrixhyaluronicacidfillerswithlidocaineintheclinicalsettinganopenlabelmulticenterstudy AT vonheimburgdennis safetyandperformanceofcohesivepolydensifiedmatrixhyaluronicacidfillerswithlidocaineintheclinicalsettinganopenlabelmulticenterstudy AT imhofmatthias safetyandperformanceofcohesivepolydensifiedmatrixhyaluronicacidfillerswithlidocaineintheclinicalsettinganopenlabelmulticenterstudy AT weissenbergerpetra safetyandperformanceofcohesivepolydensifiedmatrixhyaluronicacidfillerswithlidocaineintheclinicalsettinganopenlabelmulticenterstudy AT sattlergerhard safetyandperformanceofcohesivepolydensifiedmatrixhyaluronicacidfillerswithlidocaineintheclinicalsettinganopenlabelmulticenterstudy |