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

Daisy Kopera, Michael Palatin, Rolf Bartsch, Katrin Bartsch, Maria O'Rourke, Sonja Höller, Renate R Baumgartner, Martin Prinz, Daisy Kopera, Michael Palatin, Rolf Bartsch, Katrin Bartsch, Maria O'Rourke, Sonja Höller, Renate R Baumgartner, Martin Prinz

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.

Figures

Figure 1
Figure 1
Absolute change in Modified Fitzpatrick Wrinkle Scale score from baseline for each visit. The mean of both measurements (right/left nasolabial fold) is used. Absolute change is calculated as follows: result for respective study visit minus Day 0 result. Box plots: Box displaying lower and upper quartile; median value is displayed by horizontal line, mean by “+,” and endpoints of upper and lower whiskers display maximum and minimum values.
Figure 2
Figure 2
Percentage of subjects with an improvement in Modified Fitzpatrick Wrinkle Scale in one or both nasolabial folds at each study visit. MFWS: Modified Fitzpatrick Wrinkle Scale; grade characteristics are defined in Table 1. One: one nasolabial fold. Both: both nasolabial folds.
Figure 3
Figure 3
Global Aesthetic Improvement Scale assessments at each study visit compared to baseline. Designations right and left: corresponding to right and left nasolabial folds.

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Source: PubMed

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