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一项前瞻性单中心研究中,使用 DEF CL 容积重塑填充剂对面中部容积矫正的皮肤学效果和持久性的 12 个月分析。

A 12-Month Analysis of the Dermatologic Effects and Durability of Midface Volume Correction With DEF CL Volumizing Filler in a Prospective, Single-Center Study.

机构信息

Dameto Clinics International, Amsterdam, the Netherlands.

Dameto Clinics International, Campanet, Spain.

出版信息

Dermatol Surg. 2024 Dec 1;50(12):1131-1136. doi: 10.1097/DSS.0000000000004307. Epub 2024 Jul 2.

Abstract

BACKGROUND

Certain manufacturing processes confer distinctive rheologic features to hyaluronic acid (HA), ensuring long-lasting effects. Skin quality improvement and the volumizing effects of the DEF CL volumizer filler, a sterile, biodegradable, viscoelastic, transparent, isotonic, and homogenized injectable cross-linked high G' filler for the treatment of moderate-to-severe age-related midface changes, were initially documented at 6 months after the first injection.

OBJECTIVE

The authors aimed to objectively evaluate the effects of the DEF CL volumizer filler in improving skin density, thickness, and biomechanical properties and on tissue volume augmentation in women with midface volume loss after 12 months.

MATERIALS AND METHODS

Fifty women with midface volume loss were recruited in this prospective, noncomparative, single-center, postmarket study. The authors report changes in skin density, thickness, and quality and subjective and objective evaluation of facial and/or cheek volume augmentation using the Global Aesthetic Improvement Scale, as well as injection site reactions and adverse events.

RESULTS

Improvements in skin quality and thickness and volumization were maintained 12 months after the first injection. Injector and patient satisfaction were highly rated with only mild adverse reactions observed.

CONCLUSION

Skin improvement and volumizing effects persisted in patients treated with the DEF CL volumizer after 12 months.

摘要

背景

某些制造工艺赋予透明质酸(HA)独特的流变学特性,确保了持久的效果。DEF CL 体积填充剂的皮肤质量改善和填充效果,该填充剂为无菌、可生物降解、粘弹性、透明、等渗和均匀交联的高 G'注射用中重度年龄相关性中面部变化的治疗用中面部体积损失的女性,最初在第一次注射后 6 个月记录。

目的

作者旨在客观评估 DEF CL 体积填充剂在改善皮肤密度、厚度和生物力学特性以及增加组织体积方面的效果,这些效果是在 12 个月后中面部体积丢失的女性中观察到的。

材料和方法

本前瞻性、非对照、单中心、上市后研究招募了 50 名中面部体积丢失的女性。作者报告了皮肤密度、厚度和质量的变化,以及使用全球美学改善量表对面部和/或脸颊体积增加的主观和客观评估,以及注射部位反应和不良事件。

结果

首次注射后 12 个月,皮肤质量和厚度以及体积增加得到维持。注射者和患者的满意度评价很高,仅观察到轻微的不良反应。

结论

在 12 个月后,接受 DEF CL 体积填充剂治疗的患者皮肤改善和填充效果持续存在。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7870/11594072/628c6d25b088/ds-50-1131-g001.jpg

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