ArticleDermatology and therapy2026
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.
Article in Dermatology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
introductionThis 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.
methodsIn 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.
resultsThe 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.
conclusionsThe lidocaine-premixed HA gel is non-inferior for NLF correction, offering similar safety and efficacy with integrated anesthesia.
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