Burgess Cheryl, Dayan Steven, Bank David, Weinkle Susan, Sartor Marta, Chawla Smita, Keaney Terrence
Aesthet Surg J. 2024 Dec 12;45(1):98-107. doi: 10.1093/asj/sjae172.
A randomized study previously reported demonstration of the safety and efficacy of hyaluronic acid filler VYC-25L for restoring jawline definition.
The aim of this study was to evaluate patient-reported outcomes (PROs), objective changes in jawline profile, and safety and effectiveness measures by Fitzpatrick skin phototype (FST), gender, and age following VYC-25L treatment.
Adults were randomized to receive VYC-25L (n = 157) or no treatment (control; n = 49) for 6 months. PROs were assessed by FACE-Q Satisfaction with Lower Face and Jawline, FACE-Q Appraisal of Lines: Marionette, and participant satisfaction with treatment questionnaires. Changes in jawline profile linear depth and volume were calculated with 3-dimensional digital image analysis. Responder rates, PROs, and injection site responses (ISRs) were assessed by FST, gender, and age.
At Month 6, >70% of treated participants responded "somewhat/very satisfied" to FACE-Q Satisfaction with Lower Face and Jawline questions, and ≥78% of treated participants responded "satisfied/definitely satisfied" with treatment overall. For participants treated for the marionette lines, the FACE-Q Appraisal of Lines: Marionette questionnaire mean score improved by 32.6 (baseline to Month 6). Mean change in linear depth in the prejowl sulcus in the treatment vs control groups was 4.6 mm vs 2.5 mm, respectively, and for jawline volume was 6.0 mL and -2.6 mL, respectively (baseline to Month 6). Subanalyses showed similar outcomes by FST, gender, and age, except for a numerically higher ISR incidence in females vs males.
Treatment with VYC-25L to improve jawline definition yielded high patient satisfaction, objective improvements in jawline profile, and comparable effectiveness across various demographics.
一项随机研究先前报告了透明质酸填充剂VYC - 25L用于恢复下颌轮廓清晰度的安全性和有效性。
本研究的目的是评估患者报告的结局(PROs)、下颌轮廓的客观变化,以及VYC - 25L治疗后按菲茨帕特里克皮肤光型(FST)、性别和年龄划分的安全性和有效性指标。
将成年人随机分为接受VYC - 25L治疗组(n = 157)或不治疗对照组(n = 49),为期6个月。通过面部质量(FACE - Q)对下脸和下颌轮廓的满意度、面部质量(FACE - Q)对木偶纹的评估,以及参与者对治疗问卷的满意度来评估PROs。使用三维数字图像分析计算下颌轮廓线性深度和体积的变化。按FST、性别和年龄评估反应率、PROs和注射部位反应(ISRs)。
在第6个月时,超过70%接受治疗的参与者对面部质量(FACE - Q)下脸和下颌轮廓问题回答“有点/非常满意”,且≥78%接受治疗的参与者对总体治疗回答“满意/绝对满意”。对于接受木偶纹治疗的参与者,面部质量(FACE - Q)对木偶纹的评估问卷平均得分从基线到第6个月提高了32.6分。治疗组与对照组在前颌沟线性深度的平均变化分别为4.6毫米和2.5毫米,下颌轮廓体积的平均变化分别为6.0毫升和 - 2.6毫升(从基线到第6个月)。亚组分析显示,除女性的ISR发生率在数值上高于男性外,按FST、性别和年龄划分的结果相似。
使用VYC - 25L治疗以改善下颌轮廓清晰度可使患者满意度高,下颌轮廓有客观改善,且在不同人口统计学特征中有效性相当。