Efficacy and Safety of Sodium Hyaluronate Injection for Moderate‐To‐Severe Neck Wrinkles: A Multicenter, Single‐Blind, Randomized, Parallel‐Controlled Trial

ABSTRACT Background Hyaluronic acid (HA) occupies the micro‐environment of the dermal matrix, filling depressions and imparting a smooth appearance to the skin. HA fillers are widely used for wrinkle correction. Still, the efficacy and safety of ANN0032, a new HA‐based injection, have not yet been assessed in clinical trials for moderate to severe neck wrinkles. Objective To evaluate the efficacy and safety of ANN0032, a novel HA‐based injection, for the correction of moderate‐to‐severe horizontal neck wrinkles. Methods In this multicenter, randomized, single‐blind, parallel‐controlled trial, 156 subjects were randomized (1:1) to receive either ANN0032 treatment ( n = 78) or an established HA filler Hearty ( n = 78). The primary efficacy endpoint was the proportion of subjects achieving a ≥ 1‐point improvement on the Allergan Transverse Neck Lines Scale ( ATNLS ) at Week 4 posttreatment, as assessed by blinded evaluators. Results At Week 4, ANN0032 demonstrated non‐inferior improvement compared with Hearty, with 83.3% versus 71.8% of subjects achieving the primary endpoint (rate difference, 11.54%; 95% CI: −3.29% to 26.37%). Both groups showed comparable safety profiles with no serious adverse events reported. Conclusion ANN0032, a HA‐based filler, demonstrated non‐inferior efficacy and a favorable safety profile compared to an established HA filler, Hearty, in improving moderate‐to‐severe neck wrinkles.