A Randomized, Evaluator-Blinded, Multicenter Study to Compare Injectable Poly-D,L-Lactic Acid vs Hyaluronic Acid for Nasolabial Fold Augmentation.

IF 3 2区医学 Q1 SURGERY Aesthetic Surgery Journal Pub Date : 2024-11-15 DOI:10.1093/asj/sjae180

Wenyun Ting, Yuming Chong, Xiao Long, Maoguo Shu, Haiying Wang, Jiuzuo Huang, Ang Zeng, Zhuanli Bai, Rui Wang, Xin Zhang, Hanying Wang, Jui-Yu Lin, Chuan-Yuan Lin, Mingzi Zhang, Nanze Yu, Xiaojun Wang

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引用次数: 0

Abstract

Background: Injectable poly-D,L-lactic acid (PDLLA), under the brand name of AestheFill (REGEN Biotech, Inc., Seoul, South Korea), is a biocompatible, biodegradable, and biostimulatory product utilized to correct soft tissue volume loss. Its efficacy and safety have not been fully studied in a large cohort.

Objectives: The aim of the study was to evaluate the efficacy and safety of a novel dermal filler injectable, poly-D,L-lactic acid.

Methods: This was an evaluator-blinded, multicenter, randomized controlled trial to compare the efficacy and safety of PDLLA vs hyaluronic acid in the correction of the nasolabial fold. Two hundred and sixty patients with moderate to severe nasolabial folds were enrolled and randomized to the treatment group (PDLLA) or control group (hyaluronic acid). Each patient received a PDLLA or hyaluronic acid injection for nasolabial fold augmentation and was followed for 52 weeks. The Wrinkle Severity Rating Scale (WSRS) and Global Aesthetic Improvement Scale (GAIS) were applied to evaluate topical nasolabial fold augmentation and overall improvement, respectively.

Results: At 24 weeks, 67.6% of patients in the PDLLA group had an at least 1-grade improvement on the WSRS, compared to 60.9% of patients in the control group with an at least 1-grade improvement on the WSRS (P < .05). At each visit, the PDLLA group showed more improvement on the baseline WSRS than the control group. PDLLA was safe and well tolerated, with no severe adverse events.

Conclusions: PDLLA shows noninferior efficacy in correcting nasolabial folds compared to hyaluronic acid.

Level of evidence: 2 (therapeutic):

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一项随机、评估者对照、多中心研究，比较注射用聚 D、L-乳酸和透明质酸对鼻唇沟褶皱的增大作用。

背景：注射用聚 D、L-乳酸（PDLLA）的品牌名称为 AestheFill（德国柏林 Chaeum Pharma GmbH），是一种生物相容性、可生物降解和生物刺激性产品，用于矫正软组织容积损失。目前尚未对该产品的疗效和安全性进行全面研究：评估一种新型皮肤填充剂注射用聚 D、L-乳酸的有效性和安全性：这是一项评估者盲法、多中心、随机对照试验，旨在比较PDLLA与透明质酸在矫正鼻唇沟方面的有效性和安全性。共有 260 名中度至重度鼻唇沟患者参加了该试验，他们被随机分配到治疗组（PDLLA）或对照组（玻尿酸）。每名患者均接受了 PDLLA 或透明质酸注射，用于鼻唇沟丰盈术，并接受了 52 周的随访。皱纹严重程度量表（WSRS）和整体美学改善量表（GAIS）分别用于评估局部鼻唇沟增大和整体改善情况：24周时，67.6%的PDLLA组患者的WSRS至少提高了1个等级，而对照组中60.9%的患者的WSRS至少提高了1个等级（p结论：与透明质酸相比，PDLLA 在矫正鼻唇沟方面的疗效并不逊色。

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来源期刊

Aesthetic Surgery Journal SURGERY-

CiteScore

6.20

自引率

20.70%

发文量

309

审稿时长

6-12 weeks

期刊介绍： Aesthetic Surgery Journal is a peer-reviewed international journal focusing on scientific developments and clinical techniques in aesthetic surgery. The official publication of The Aesthetic Society, ASJ is also the official English-language journal of many major international societies of plastic, aesthetic and reconstructive surgery representing South America, Central America, Europe, Asia, and the Middle East. It is also the official journal of the British Association of Aesthetic Plastic Surgeons, the Canadian Society for Aesthetic Plastic Surgery and The Rhinoplasty Society.