Foliage Intense Filler, Affects Nasolabial Folds Wrinkles: Effectiveness and Safety by Prospective Comparative Study
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Background: This interventional clinical study, prospectively compared two Hyaluronic Acid (HA) filler to combat nasolabial folds (NLFs). The main goal was to verify the effectiveness and safety of Foliage Intense (FI) in front of Belotero Intense (BI) through assessing both Wrinkle Severity Rating Scale (WSRS) score in aesthetic patients showing moderate or severe NLF condition. Methods: Ninety-five patients were enrolled prospectively. In order two compare both products a double randomized split-face model was used. The primary end-points were to assess the differences concerning the (WSRS) in order to demonstrate both no-inferiority efficacy of FI with respect to BI, after six-months treatment (Wilcoxon signed-rank test; p<0.05)). Results: In Per Protocol (PP) analysis, the changes from baseline in WSRS scores at 6 months were -0.50±0.53 in the FI and -0.48±0.56 in the BI groups, respectively. Similarly, in Intention to Treat (ITT) population, changes from baseline in WSRS scores at 6 months were -0.72±0.74 in the BI and -0.73±0.72 in the FI groups, respectively (p<0.001). Conclusions: As whole, the mean score analyses revealed better results in FI applications with respect to those concerning BI. Finally, the comparison did not show significant differences in terms of Global Aesthetic Improvement Scale (GAIS) and safety.