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
Joint Authors
Palatin, Michael
Bartsch, Rolf
Bartsch, Katrin
O’Rourke, Maria
Höller, Sonja
Baumgartner, Renate R.
Prinz, Martin
Kopera, Daisy
Source
Issue
Vol. 2015, Issue 2015 (31 Dec. 2015), pp.1-7, 7 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2015-03-03
Country of Publication
Egypt
No. of Pages
7
Main Subjects
Abstract EN
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.
American Psychological Association (APA)
Kopera, Daisy& Palatin, Michael& Bartsch, Rolf& Bartsch, Katrin& O’Rourke, Maria& Höller, Sonja…[et al.]. 2015. 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. BioMed Research International،Vol. 2015, no. 2015, pp.1-7.
https://search.emarefa.net/detail/BIM-1054582
Modern Language Association (MLA)
Kopera, Daisy…[et al.]. 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. BioMed Research International No. 2015 (2015), pp.1-7.
https://search.emarefa.net/detail/BIM-1054582
American Medical Association (AMA)
Kopera, Daisy& Palatin, Michael& Bartsch, Rolf& Bartsch, Katrin& O’Rourke, Maria& Höller, Sonja…[et al.]. 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. BioMed Research International. 2015. Vol. 2015, no. 2015, pp.1-7.
https://search.emarefa.net/detail/BIM-1054582
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1054582