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Introduction <p>This study evaluates a novel lidocaine-premixed hyaluronic acid (HA) gel for nasolabial fold (NLF) correction, addressing pain management and longevity challenges in facial rejuvenation. The aim is to assess the non-inferiority, efficacy, and safety of this investigational HA gel versus an established comparator.</p> Methods <p>In this multicenter, evaluator-blinded randomized controlled trial (RCT), 324 Chinese adults with moderate-to-severe NLFs (Wrinkle Severity Rating Scale [WSRS] 3–4) received either test product (22&#xa0;mg/mL HA + 3&#xa0;mg/mL lidocaine) or control. The primary endpoint was ≥ 1&#xa0;grade WSRS improvement at 6&#xa0;months.</p> Results <p>The test product showed non-inferiority at 6&#xa0;months (full analysis set [FAS]: 88.27% versus 85.19%, <i>P</i> = 0.392; per‑protocol set (PPS): 91.45% versus 88.24%, <i>P</i> = 0.363), with 95% confidence intervals (CIs) exceeding a −10% margin. Pain scores were comparable at 0.5&#xa0;h/1&#xa0;h post-injection (<i>P</i> &gt; 0.05) but higher at 2&#xa0;h post-touch-up (<i>P</i> &lt; 0.05). Adverse event (AE) rates were similar, with induration/swelling being most common.</p> Conclusions <p>The lidocaine-premixed HA gel is non-inferior for NLF correction, offering similar safety and efficacy with integrated anesthesia.</p>

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Prospective Evaluation of Cross-linked Sodium Hyaluronate Gel for Injection in Treating Moderate-to-Severe Nasolabial Folds: A Randomized Controlled Evaluator-Blind Non-inferiority Study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月25日

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  • Xinlyu Huang,
  • Yankun Zhang,
  • Jie Dong,
  • Xiaowei Qin,
  • Shixin Yang,
  • Jun Li,
  • Lanying Qin,
  • Fang Liu

摘要

Introduction

This study evaluates a novel lidocaine-premixed hyaluronic acid (HA) gel for nasolabial fold (NLF) correction, addressing pain management and longevity challenges in facial rejuvenation. The aim is to assess the non-inferiority, efficacy, and safety of this investigational HA gel versus an established comparator.

Methods

In this multicenter, evaluator-blinded randomized controlled trial (RCT), 324 Chinese adults with moderate-to-severe NLFs (Wrinkle Severity Rating Scale [WSRS] 3–4) received either test product (22 mg/mL HA + 3 mg/mL lidocaine) or control. The primary endpoint was ≥ 1 grade WSRS improvement at 6 months.

Results

The test product showed non-inferiority at 6 months (full analysis set [FAS]: 88.27% versus 85.19%, P = 0.392; per‑protocol set (PPS): 91.45% versus 88.24%, P = 0.363), with 95% confidence intervals (CIs) exceeding a −10% margin. Pain scores were comparable at 0.5 h/1 h post-injection (P > 0.05) but higher at 2 h post-touch-up (P < 0.05). Adverse event (AE) rates were similar, with induration/swelling being most common.

Conclusions

The lidocaine-premixed HA gel is non-inferior for NLF correction, offering similar safety and efficacy with integrated anesthesia.