一种用于容积恢复的新型透明质酸真皮填充剂的评估。

Evaluation of a new hyaluronic acid dermal filler for volume restoration.

作者信息

Alessandrini Andrea, Fino Pasquale, Giordan Nicola, Amorosi Vittoria, Scuderi Nicolò

机构信息

a Clinical Professor of International Foundation Fatebenefratelli Rome, School of Aesthetic Medicine; Private Practice, Aesthetic Medicine , Rome , Italy.

b Department of Plastic , Reconstructive and Aesthetic Surgery, 'Sapienza' University , Policlinico 'Umberto I', Rome , Italy.

出版信息

J Cosmet Laser Ther. 2015;17(6):335-42. doi: 10.3109/14764172.2015.1039038. Epub 2015 Jul 20.

DOI:10.3109/14764172.2015.1039038

PMID:25968167

Abstract

OBJECTIVES

The present study aimed to evaluate the effectiveness and safety of hyaluronic acid gel for the treatment of volume loss or contour deficiency.

METHODS

This 6-month, open-label study recruited sixty adults aged 40-65 years with bilateral moderate to severe volume loss or contour deficiency (Facial Volume Loss Scale [FVLS] score: 2-5). Eligible subjects were treated at the baseline visit with an injection of hyaluronic acid gel in one or more of three facial subregions: the zygomatic malar region, the anteromedial cheek and nasolabial folds.

RESULTS

A significant improvement from baseline was observed in the FVLS score at each study visit up to 6 months post treatment (p < 0.0125 by Wilcoxon test). A significant improvement was also observed in the Global Aesthetic Improvement Scale (GAIS) at each visit up to 6 months. The study showed that the GAIS score improved in 100% of subjects at month 3, while at the end of the study (month 6) the percentage of improved subjects decreased to 91. Treatment effect was maintained by 100% of subjects up to month 3, while 57% of subjects showed a persistence of effect up to month 6.

CONCLUSIONS

Volume loss or contour deficiency may be safely and effectively corrected using the new dermal filler.

摘要

目的

本研究旨在评估透明质酸凝胶治疗容量缺失或轮廓缺陷的有效性和安全性。

方法

这项为期6个月的开放标签研究招募了60名年龄在40 - 65岁之间、双侧存在中度至重度容量缺失或轮廓缺陷（面部容量缺失量表[FVLS]评分：2 - 5）的成年人。符合条件的受试者在基线访视时，在三个面部亚区域中的一个或多个区域注射透明质酸凝胶，这三个区域分别是颧颊区域、脸颊前内侧和鼻唇沟。

结果

在治疗后长达6个月的每次研究访视中，FVLS评分均较基线有显著改善（Wilcoxon检验，p < 0.0125）。在长达6个月的每次访视中，全球美学改善量表（GAIS）也有显著改善。研究表明，在第3个月时，100%的受试者GAIS评分有所改善，而在研究结束时（第6个月），改善的受试者百分比降至91%。100%的受试者在第3个月时治疗效果得以维持，而在第6个月时，57%的受试者仍有持续效果。