Safety and performance of cohesive polydensified matrix hyaluronic acid fillers with lidocaine in the clinical setting - an open-label, multicenter study.

作者: Ulrich Kühne , Jorgen Esmann , Dennis von Heimburg , Matthias Imhof , Petra Weissenberger

DOI: 10.2147/CCID.S115256

关键词:

摘要: 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 CPM® lidocaine in clinical setting. In an open-label, prospective, postmarketing study, 108 patients from seven sites Germany Denmark were treated one more lidocaine-containing fillers. Performance assessed using Merz Aesthetics Scales® (MAS). Pain rated on 11-point visual analog scale. Patients' physicians' satisfaction as well adverse events recorded. Improvements ≥1-point MAS immediately after 17 days posttreatment observed ~90% compared baseline. All investigators ejection force, product positioning, similar superior respective nonlidocaine products. Overall, 94% satisfied esthetic outcomes willing continue except results, all repeat treatment. Mean pain scores low during (<3.0) injection (<0.6). Except for case bruising, mild moderate. safe effective a wide range facial indications.

参考文章(23)
J Moreno-Moraga, MJ Isarría, E Muñoz, I Cruz, G Pérez, P Cornejo, None, The evaluation of hyaluronic acid, with and without lidocaine, in the filling of nasolabial folds as measured by ultrastructural changes and pain management. Journal of Drugs in Dermatology. ,vol. 12, ,(2013)
Oscar Hevia, David J Howell, Bernard H Cohen, Safety and efficacy of a cohesive polydensified matrix hyaluronic acid for the correction of infraorbital hollow: an observational study with results at 40 weeks. Journal of Drugs in Dermatology. ,vol. 13, pp. 1030- 1036 ,(2014)
Jean Carruthers, Timothy C. Flynn, Thorin L. Geister, Roman Görtelmeyer, Bhushan Hardas, Silvia Himmrich, Derek Jones, Martina Kerscher, Maurício de Maio, Cornelia Mohrmann, Rhoda S. Narins, Rainer Pooth, Berthold Rzany, Gerhard Sattler, Larry Buchner, Ursula Benter, Lusine Breitscheidel, Alastair Carruthers, Validated assessment scales for the mid face. Dermatologic Surgery. ,vol. 38, pp. 320- 332 ,(2012) , 10.1111/J.1524-4725.2011.02251.X
Z. Paul Lorenc, Steven Fagien, Timothy C. Flynn, Heidi A. Waldorf, Review of key Belotero Balance safety and efficacy trials. Plastic and Reconstructive Surgery. ,vol. 132, ,(2013) , 10.1097/PRS.0B013E31829A07D5
Amir Moradi, Azadeh Shirazi, Jeanette Moradi-Poehler, Jessica Turner, David J. Howell, A Blinded, Randomized, Split-Face Pilot Study of Bruising and Pain With Hyaluronic Acid for Correction of Perioral Lines Using No Lidocaine, Lidocaine Alone, and Lidocaine and Epinephrine Aesthetic Surgery Journal. ,vol. 35, pp. 443- 455 ,(2015) , 10.1093/ASJ/SJV043
Tatjana Pavicic, David Funt, Dermal fillers in aesthetics: an overview of adverse events and treatment approaches Clinical, Cosmetic and Investigational Dermatology. ,vol. 6, pp. 295- 316 ,(2013) , 10.2147/CCID.S50546
Rhoda S. Narins, Jean Carruthers, Timothy C. Flynn, Thorin L. Geister, Roman Görtelmeyer, Bhushan Hardas, Silvia Himmrich, Derek Jones, Martina Kerscher, Maurício de Maio, Cornelia Mohrmann, Rainer Pooth, Berthold Rzany, Gerhard Sattler, Larry Buchner, Ursula Benter, Lusine Breitscheidel, Alastair Carruthers, Validated assessment scales for the lower face. Dermatologic Surgery. ,vol. 38, pp. 333- 342 ,(2012) , 10.1111/J.1524-4725.2011.02247.X
Wolfgang G Philipp‐Dormston, Said Hilton, Myooran Nathan, A prospective, open-label, multicenter, observational, postmarket study of the use of a 15 mg/mL hyaluronic acid dermal filler in the lips. Journal of Cosmetic Dermatology. ,vol. 13, pp. 125- 134 ,(2014) , 10.1111/JOCD.12085