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

Abstract

Nasolabial folds (NLFs) are a common cosmetic concern. 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 with the widely used Juvéderm. A 24-week, prospective, single-center, double-blind, randomized, split-face, noninferiority controlled trial was conducted. Seventy-four participants with moderate to severe NLFs were enrolled and treated with Curea on one side of the face and Juvéderm on the other. Evaluation included NLF improvement as determined using the Wrinkle Severity Rating Scale, participant satisfaction, and adverse events. At 24 weeks, Curea significantly improved Wrinkle Severity Rating Scale 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 noninferiority margin compared with Juvéderm. The safety profiles and participant satisfaction for Curea were similar to those for Juvéderm. Only mild, transient local reactions were observed, and participants were satisfied with the clinical improvement of both fillers throughout the 24-week follow-up. Curea is comparable to Juvéderm in NLF correction and safety profiles, and its efficacy lasts up to 24 weeks.