Efficacy and Safety of New Hyaluronic Acid Filler for Nasolabial Fold Correction: A Double-Blind, Randomized Trial

Background: Nasolabial folds (NLFs) are a common cosmetic concern that makes people look older. Hyaluronic acid (HA)-based fillers are increasingly popular for minimally invasive facial wrinkle and fold correction. This study aimed to evaluate the efficacy and safety of a new monophasic HA filler, CUREA ® , for NLF correction compared to the widely used Juvederm ® . Methods: A 24-week, prospective, single-center, double-blind, randomized, split-face, non-inferiority controlled trial was conducted. Seventy-four participants with moderate-to-severe NLFs were enrolled and treated with CUREA ® on one side of the face or Juvederm ® on the other. Evaluation included NLF improvement as determined using the Wrinkle Severity Rating Scale (WSRS), participant satisfaction, and adverse events. Results: At 24 weeks, CUREA ® significantly improved WSRS scores from 3.16 ± 0.84 at baseline to 2.59 ± 0.87 at week 24 ( P <0.001). CUREA ® demonstrated efficacy for NLF correction within the predefined non-inferiority margin compared to Juvederm ® . The safety profiles and participant satisfaction for CUREA ® were similar to those for Juvederm ® . Only mild, transient local reactions were observed, and participants were satisfied with the clinical improvement of both fillers throughout the 24-week follow up. Conclusions: CUREA ® is comparable to Juvederm ® in NLF correction and safety profiles, and its efficacy lasts up to 24 weeks.