Dermatological Fillers with Hyaluronic Acid Improve Nasolabial Fold Wrinkles: Efficacy and Safety According to a Prospective Comparative Study

Background: This interventional clinical study prospectively compared two hyaluronic acid (HA) fillers to combat nasolabial folds (NLFs).The main goal was to verify the effectiveness and safety of Foliage Intense (FI) over Belotero Intense (BI) by assessing the Wrinkle Severity Rating Scale (WSRS) score in aesthetic patients showing either moderate or severe NLF conditions.Methods: Ninety-five patients were enrolled prospectively.To compare the two products, a double-randomized split-face model was used.The primary endpoints were the differences in the WSRS to demonstrate the efficacy of FI compared to BI after a six-month treatment (Wilcoxon rank test; p<0.05). Results:In the Per Protocol (PP) analysis, the changes in the WSRS score from baseline to 6 months were -0.50±0.13 in the FI group and -0.48±0.12 in the BI group.Similarly, in the Intention to Treat (ITT) population, changes in WSRS scores from baseline to 6 months were -0.72±0.13 in the BI group and -0.73±0.14 in the FI group (p<0.001). Conclusions:Overall, the mean score analyses revealed better results in FI applications compared to BI.However, the comparison did not show significant differences in terms of Global Aesthetic Improvement Scale (GAIS) or safety.