Efficacy and Safety of Sodium Hyaluronate Injection for Moderate-To-Severe Neck Wrinkles

BACKGROUNDHyaluronic 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.

OBJECTIVETo evaluate the efficacy and safety of ANN0032, a novel HA-based injection, for the correction of moderate-to-severe horizontal neck wrinkles.

METHODSIn 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.

RESULTSAt 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.

CONCLUSIONANN0032, 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.

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