Noninferiority Study Comparing the Efficacy and Safety of a New Hyaluronic Acid (HA) Filler Containing Lidocaine With an Existing HA Filler for the Treatment of Nasolabial Fold Wrinkles: A Randomized, Double-Blind, Split-Face Trial

IF 2.5 4区医学 Q2 DERMATOLOGY

Journal of Cosmetic Dermatology Pub Date : 2025-07-07 DOI:10.1111/jocd.70309

Ji Young Cho, Seung Hyeon Kim, Hyesoo Cho, Yoonjae Park, Hee Joo Yang, Jee Soo An, Chong Hyun Won, Jong Hun Lee

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引用次数: 0

Abstract

Background

The aesthetic use of hyaluronic acid (HA) has led to the development of various commercial HA fillers. Crosslinked HA dermal fillers are commonly used to treat facial wrinkles. This study demonstrated the non-inferiority of the newly developed hyaluronic acid filler by comparing its efficacy and safety to that of the existing hyaluronic acid filler.

Methods

This 48-week study was designed as a randomized, double-blind, split-face trial. Subjects who met the inclusion and exclusion criteria had a total of four follow-up visits after receiving a dermal filler in the nasolabial folds. Efficacy was assessed using the Wrinkle Severity Rating Score (WSRS) and the Global Aesthetic Improvement Scale (GAIS). Safety was determined through the evaluation of laboratory tests, monitoring adverse events, and verifying vital signs.

Results

WSRS measured at week 24 of the follow-up visit showed no statistically significant difference, with scores of 2.02 ± 0.71 in the new filler group and 2.27 ± 0.68 in the existing filler group. Even at the 48-week follow-up visit, the improvement rate in the Wrinkle Severity Rating Scale (WSRS) of more than 1 point did not show a statistically significant difference between the new filler group and the existing filler group. The GAIS scores at each follow-up visit showed no statistically significant differences between the two groups. The most frequently reported symptoms related to the test device during the 48-week trial were pain and swelling. However, these symptoms were not statistically significant when compared to the control group from a treatment perspective.

Conclusions

In a 48-week clinical trial aimed at treating nasolabial fold (NLF) wrinkles, the new hyaluronic acid (HA) filler demonstrated efficacy and safety comparable to that of existing control filler. As a result, the new HA filler is both an effective and safe option for improving NLF wrinkles.

Trial Registration

This study was registered with ClinicalTrials.gov under the registration number NCT06310863

Abstract Image

查看原文本刊更多论文

一项随机、双盲、裂面试验：比较含有利多卡因的新型透明质酸（HA）填充剂与现有HA填充剂治疗鼻唇襞皱纹的疗效和安全性的非劣效性研究

透明质酸（HA）的美学用途导致了各种商用透明质酸填充剂的发展。交联透明质酸真皮填充剂通常用于治疗面部皱纹。本研究通过与现有透明质酸填充剂的有效性和安全性进行比较，证明了新开发的透明质酸填充剂的非劣效性。方法本研究采用随机、双盲、裂面试验，为期48周。符合纳入和排除标准的受试者在鼻唇沟接受真皮填充物后共进行了四次随访。使用皱纹严重性评分（WSRS）和全球美学改善量表（GAIS）评估疗效。安全性是通过评估实验室试验、监测不良事件和验证生命体征来确定的。结果随访第24周wrs评分差异无统计学意义，新牙组wrs评分为2.02±0.71，旧牙组wrs评分为2.27±0.68。即使在48周的随访中，皱纹严重程度评定量表（WSRS）的改善率超过1分，新填料组与现有填料组之间也没有统计学上的显着差异。每次随访的GAIS得分在两组之间没有统计学上的显著差异。在48周的试验期间，与测试装置相关的最常报告的症状是疼痛和肿胀。然而，从治疗的角度来看，与对照组相比，这些症状没有统计学意义。在一项为期48周的治疗鼻唇沟（NLF）皱纹的临床试验中，新型透明质酸（HA）填充剂的疗效和安全性与现有对照填充剂相当。因此，新的HA填充剂是一种既有效又安全的选择，以改善NLF皱纹。本研究已在ClinicalTrials.gov注册，注册号为NCT06310863

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来源期刊

Journal of Cosmetic Dermatology DERMATOLOGY-

CiteScore

4.30

自引率

13.00%

发文量

818

审稿时长

>12 weeks

期刊介绍： The Journal of Cosmetic Dermatology publishes high quality, peer-reviewed articles on all aspects of cosmetic dermatology with the aim to foster the highest standards of patient care in cosmetic dermatology. Published quarterly, the Journal of Cosmetic Dermatology facilitates continuing professional development and provides a forum for the exchange of scientific research and innovative techniques. The scope of coverage includes, but will not be limited to: healthy skin; skin maintenance; ageing skin; photodamage and photoprotection; rejuvenation; biochemistry, endocrinology and neuroimmunology of healthy skin; imaging; skin measurement; quality of life; skin types; sensitive skin; rosacea and acne; sebum; sweat; fat; phlebology; hair conservation, restoration and removal; nails and nail surgery; pigment; psychological and medicolegal issues; retinoids; cosmetic chemistry; dermopharmacy; cosmeceuticals; toiletries; striae; cellulite; cosmetic dermatological surgery; blepharoplasty; liposuction; surgical complications; botulinum; fillers, peels and dermabrasion; local and tumescent anaesthesia; electrosurgery; lasers, including laser physics, laser research and safety, vascular lasers, pigment lasers, hair removal lasers, tattoo removal lasers, resurfacing lasers, dermal remodelling lasers and laser complications.