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Background <p>Cross-linked hyaluronic acid (HA) fillers are the standard nonsurgical modality for correcting nasolabial folds (NLFs); however, treatment costs associated with imported products limit patient accessibility in many regions. This study evaluated the in vivo performance and safety of a novel, domestically manufactured sodium hyaluronate hydrogel formulation versus Restylane® for the correction of moderate-to-severe NLFs, aiming to provide a high-quality, more accessible treatment alternative.</p> Methods <p>In this prospective, multicenter, randomized, evaluator- and participant-blinded, active-controlled trial, 257 participants with moderate-to-severe NLFs were randomized (1:1) to receive the investigational hydrogel or Restylane®. The primary endpoint was the response rate (≥ 1-point improvement on the Wrinkle Severity Rating Scale [WSRS]) at 24&#xa0;weeks. Secondary endpoints included WSRS changes, Global Aesthetic Improvement Scale (GAIS) scores, safety assessments, and an analysis of physiological factors influencing hydrogel performance.</p> Results <p>In the Full Analysis Set, the 24-week response rate was 68.0% for the investigational group versus 57.4% for the control group. The between-group difference was 10.8% (95% CI − 0.6 to 22.1), confirming noninferiority. The incidence of adverse events showed no statistically significant difference between groups, with all events being transient and mild-to-moderate. Multivariate analysis identified body mass index (BMI) (OR = 0.837; <i>P</i> = 0.002) as an independent predictor of efficacy. Exploratory subgroup analysis supported this inverse association, suggesting a potential interaction between BMI status and clinical response (<i>P</i> = 0.025).</p> Conclusions <p>The novel HA hydrogel demonstrated noninferiority to Restylane®, exhibiting sustained clinical efficacy and a favorable safety profile. The observed association between higher BMI and reduced efficacy, while exploratory, suggests that patient-specific biomechanical factors may influence treatment outcomes and warrant consideration in personalized treatment planning.</p> <p><i>Trial Registration</i> Chinese Clinical Trial Registry, ChiCTR2600118966. Registered 13 February 2026—Retrospectively registered. (Original administrative filing: Shandong Provincial Medical Products Administration, No. LuXieLinBei20240018, Registration Date: April 1, 2024).</p>

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Efficacy and safety of a novel cross-linked sodium hyaluronate gel for the correction of moderate-to-severe nasolabial folds: a multicenter, randomized, evaluator- and participant-blinded, active-controlled noninferiority trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月23日

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  • Xiecheng Zhou,
  • Xuan Jiang,
  • Jinming Zhang,
  • Chenggang Yi,
  • Shu Guo,
  • Xinhai Liu,
  • Zhiping Zhang,
  • Meiling Cao,
  • Xiangdong Qi

摘要

Background

Cross-linked hyaluronic acid (HA) fillers are the standard nonsurgical modality for correcting nasolabial folds (NLFs); however, treatment costs associated with imported products limit patient accessibility in many regions. This study evaluated the in vivo performance and safety of a novel, domestically manufactured sodium hyaluronate hydrogel formulation versus Restylane® for the correction of moderate-to-severe NLFs, aiming to provide a high-quality, more accessible treatment alternative.

Methods

In this prospective, multicenter, randomized, evaluator- and participant-blinded, active-controlled trial, 257 participants with moderate-to-severe NLFs were randomized (1:1) to receive the investigational hydrogel or Restylane®. The primary endpoint was the response rate (≥ 1-point improvement on the Wrinkle Severity Rating Scale [WSRS]) at 24 weeks. Secondary endpoints included WSRS changes, Global Aesthetic Improvement Scale (GAIS) scores, safety assessments, and an analysis of physiological factors influencing hydrogel performance.

Results

In the Full Analysis Set, the 24-week response rate was 68.0% for the investigational group versus 57.4% for the control group. The between-group difference was 10.8% (95% CI − 0.6 to 22.1), confirming noninferiority. The incidence of adverse events showed no statistically significant difference between groups, with all events being transient and mild-to-moderate. Multivariate analysis identified body mass index (BMI) (OR = 0.837; P = 0.002) as an independent predictor of efficacy. Exploratory subgroup analysis supported this inverse association, suggesting a potential interaction between BMI status and clinical response (P = 0.025).

Conclusions

The novel HA hydrogel demonstrated noninferiority to Restylane®, exhibiting sustained clinical efficacy and a favorable safety profile. The observed association between higher BMI and reduced efficacy, while exploratory, suggests that patient-specific biomechanical factors may influence treatment outcomes and warrant consideration in personalized treatment planning.

Trial Registration Chinese Clinical Trial Registry, ChiCTR2600118966. Registered 13 February 2026—Retrospectively registered. (Original administrative filing: Shandong Provincial Medical Products Administration, No. LuXieLinBei20240018, Registration Date: April 1, 2024).