透明质酸用于中面部容积填充：来自一项对照、随机、双盲临床研究的注射技术与安全性方面

Mid-Face Volumization With Hyaluronic Acid: Injection Technique and Safety Aspects from a Controlled, Randomized, Double-Blind Clinical Study.

作者信息

Prager Welf, Agsten Karla, Kravtsov Maria, Kerscher Prof Martina

出版信息

J Drugs Dermatol. 2017 Apr 1;16(4):351-357.

Abstract

UNLABELLED

BACKGROUND: Injection of hyaluronic acid (HA) volumizing fillers in the malar area is intended for rejuvenation of the mid-face. The choice of products, depth, and technique of injection depends on the desired level of volume enhancement and practitioners' preferences.

OBJECTIVE: To describe a volumizing injection technique in the scope of a controlled, randomized, double-blind, single-center, split-face clinical study.

MATERIALS & METHODS: A total of 45 subjects with bilateral symmetrical moderate to severe volume loss in the malar area received a single 2 mL injection of CPM®-26 (Cohesive Polydensified Matrix®) on one side and VYC®-20 (VYCROSS®) on the contralateral side of the face. The same injection technique was applied for both sides of the face. Use of anesthetics, overcorrection, and touch-ups were not permitted. The investigator completed a product satisfaction questionnaire. Adverse events (AE) and injection-site reactions (ISRs) were reported during the study.

RESULTS: The products were placed at the epiperiosteal depth in 88.9% (n=40), at the subdermal depth in 8.9% (n=4) and at both levels in 2.2% (n=1) of subjects. Fanning technique using cannulae was applied in most cases (97.8%, n=44). Results of the investigator satisfaction questionnaire allowed to characterize CPM-26 in comparison to other volumizing gels. Both study products were generally well tolerated. Local reactions were transient and of mild to moderate intensity, with the most frequent ones being redness, pain, and swelling.

CONCLUSION: Adequate injection technique in volumizing treatments is essential to create a natural aesthetic rejuvenation while respecting the safety aspect of the procedures. A 22G blunt cannula used with CPM-26 was preferred due to an easier and a more homogeneous distribution of the product. The investigator also appreciated CPM-26 for its ease of injection, positioning, lifting, and volumizing capacity.

J Drugs Dermatol. 2017;16(4):351-357.

摘要

未标注

背景

在颧部注射透明质酸（HA）填充剂旨在使面部中部年轻化。产品的选择、注射深度和技术取决于期望的体积增加水平和从业者的偏好。

目的

在一项对照、随机、双盲、单中心、半脸临床研究范围内描述一种体积增加注射技术。

材料与方法

共有45名双侧颧部对称性中度至重度体积缺失的受试者，一侧面部单次注射2 mL CPM®-26（凝聚性多密度基质®），对侧面部注射VYC®-20（VYCROSS®）。面部两侧采用相同的注射技术。不允许使用麻醉剂、过度矫正和补打。研究者完成了一份产品满意度问卷。研究期间报告了不良事件（AE）和注射部位反应（ISR）。

结果

88.9%（n = 40）的受试者产品置于骨膜上深度，8.9%（n = 4）置于皮下深度，2.2%（n = 1）置于两个层面。大多数情况下（97.8%，n = 44）采用套管扇形技术。研究者满意度问卷结果有助于将CPM-26与其他体积增加凝胶进行比较。两种研究产品总体耐受性良好。局部反应短暂，强度为轻度至中度，最常见的是发红、疼痛和肿胀。