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基于透明质酸的真皮填充剂 VYC-17.5L 改善颊线:BEAM 研究结果。

Improvement of Radial Cheek Lines With Hyaluronic Acid-Based Dermal Filler VYC-17.5L: Results of the BEAM Study.

机构信息

SkinConcept, Munich, Germany.

University of Goettingen, Goettingen, Germany.

出版信息

Dermatol Surg. 2020 Mar;46(3):376-385. doi: 10.1097/DSS.0000000000002057.

Abstract

BACKGROUND

Radial cheek lines (RCL) may convey an older, potentially less attractive appearance.

OBJECTIVE

To evaluate the effectiveness of hyaluronic acid-based dermal filler VYC-17.5L for correcting RCL.

MATERIALS AND METHODS

Fifty-three women (40-65 years) received injections of VYC-17.5L in both cheeks on Day 1 (optional Day 14 touch-up). Effectiveness was evaluated on Day 45 by subject-rated dynamic RCL improvement (Global Aesthetic Improvement Scale [GAIS]; primary end point) and independent, noninjecting investigator-rated GAIS; subject Self-Perception of Age (SPA); subject-assessed satisfaction with and natural look of treatment; and instrument-assessed changes in static and dynamic RCL roughness, amplitude, and texture (secondary end points). Safety assessments included injection site responses (ISRs).

RESULTS

On Day 45, 98% of subjects rated RCL as improved or much improved (investigator rated: 95%). Subjects with same or older SPA before treatment (n = 38) perceived themselves as 2.0 and 5.5 average years younger after treatment, respectively. Day 45 mean satisfaction with and natural look of treated areas was 7.9/10 and 7.2/10, respectively. Treatment significantly improved RCL roughness, amplitude, and texture (all p < .001). Most common ISRs were hematoma (35.9%), bruising (30.2%), and irregularities/bumps (22.6%); most ISRs were mild.

CONCLUSION

VYC-17.5L effectively corrected dynamic RCL, improved instrument-assessed indicators of skin quality, and resulted in younger age perception.

摘要

背景

颊侧放射纹(RCL)可能会让人显得更老,缺乏吸引力。

目的

评估透明质酸真皮填充剂 VYC-17.5L 矫正 RCL 的效果。

材料与方法

53 名 40-65 岁女性在第 1 天(可选第 14 天补注)双侧颊部接受 VYC-17.5L 注射。第 45 天,通过受试者评价的动态 RCL 改善(整体美学改善量表[GAIS];主要终点)和独立、非注射研究者评价的 GAIS;受试者自我感知年龄(SPA);受试者对治疗的满意度和自然外观;以及仪器评估的静态和动态 RCL 粗糙度、振幅和纹理变化(次要终点)来评估疗效。安全性评估包括注射部位反应(ISR)。

结果

第 45 天,98%的受试者评价 RCL 改善或明显改善(研究者评价:95%)。治疗前 SPA 相同或更老的 38 名受试者分别自我感知年轻 2.0 岁和 5.5 岁。第 45 天,治疗区域的满意度和自然外观的平均评分为 7.9/10 和 7.2/10。治疗显著改善了 RCL 的粗糙度、振幅和纹理(均 p<.001)。最常见的 ISR 是血肿(35.9%)、瘀斑(30.2%)和不规则/肿块(22.6%);大多数 ISR 为轻度。

结论

VYC-17.5L 可有效矫正动态 RCL,改善皮肤质量的仪器评估指标,并使患者自我感知更年轻。

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