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.
Xinlyu Huang, Yankun Zhang, Jie Dong, Xiaowei Qin, Shixin Yang, Jun Li, Lanying Qin, Fang Liu
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引用次数: 0
Abstract
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.
期刊介绍：
Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged.
Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.
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