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.
abstract: 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.
authors.affiliation: Department of Dermatology and Venereology, Medical University of Graz, Auenbruggerplatz 8, 8036 Graz, Austria.
authors.forename: Daisy
authors.initials: D
authors.lastname: Kopera
authors.affiliation: Praxis Dr. Palatin, Rotenturmstrasse 1, 1010 Vienna, Austria.
authors.forename: Michael
authors.initials: M
authors.lastname: Palatin
authors.affiliation: Institut für Plastische Chirurgie Wien 19 GmbH, Sieveringer Straße 36, 1190 Wien, Austria.
authors.forename: Rolf
authors.initials: R
authors.lastname: Bartsch
authors.affiliation: Institut für Plastische Chirurgie Wien 19 GmbH, Sieveringer Straße 36, 1190 Wien, Austria.
authors.forename: Katrin
authors.initials: K
authors.lastname: Bartsch
authors.affiliation: Clinical Development, CROMA PHARMA GmbH, Industriezeile 6, 2100 Leobendorf, Austria.
authors.forename: Maria
authors.initials: M
authors.lastname: O'Rourke
authors.affiliation: Clinical Development, CROMA PHARMA GmbH, Industriezeile 6, 2100 Leobendorf, Austria.
authors.forename: Sonja
authors.initials: S
authors.lastname: Höller
authors.affiliation: Clinical Development, CROMA PHARMA GmbH, Industriezeile 6, 2100 Leobendorf, Austria.
authors.forename: Renate R
authors.initials: RR
authors.lastname: Baumgartner
authors.affiliation: Clinical Development, CROMA PHARMA GmbH, Industriezeile 6, 2100 Leobendorf, Austria.
authors.forename: Martin
authors.initials: M
authors.lastname: Prinz
mesh_terms: D000328:Adult; D000368:Aged; D001317:Austria; D003357:Cosmetic Techniques; D000067548:Dermal Fillers / Q000009:adverse effects* / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008875:Middle Aged; D060052:Nasolabial Fold / Q000033:anatomy & histology*; D017060:Patient Satisfaction; D015595:Skin Aging / Q000187:drug effects*; D016896:Treatment Outcome
chemical_list: D000067548:Dermal Fillers
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