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保妥适肉毒毒素 A 治疗千禧一代中重度眉间纹:III 期临床研究数据的事后分析。

PrabotulinumtoxinA for Treatment of Millennials With Moderate to Severe Glabellar Lines: Post Hoc Analyses of the Phase III Clinical Study Data.

机构信息

Dermatologist, SkinConcept, Munich, Germany.

Skin Care and Laser Physicians of Beverly Hills, Los Angeles, California.

出版信息

Dermatol Surg. 2022 Jun 1;48(6):664-669. doi: 10.1097/DSS.0000000000003456. Epub 2022 May 19.

Abstract

BACKGROUND

The use of esthetic products by millennials is increasing, yet published clinical trial data in this population are limited.

OBJECTIVE

To compare the efficacy and safety of prabotulinumtoxinA for the treatment of moderate to severe glabellar lines in millennial and nonmillennial patients.

METHODS AND MATERIALS

Post hoc analyses were performed on the pooled population of all patients treated with 20U prabotulinumtoxinA in the 3 single-dose Phase III glabellar line clinical studies. Patients were grouped by age: millennials (born 1982-2000) versus nonmillennials (born ≤1981). One key efficacy end point was the proportion of responders with a ≥1-point improvement from baseline at maximum frown on the 4-point Glabellar Line Scale. Adverse events were also summarized.

RESULTS

Responder rates among millennials (n = 65) were greater than those of nonmillennials (n = 668) by 7.7% on average across all visits; differences were statistically significant at Day 90. Responder rates at Day 90 were 90.2% and 76.1%, respectively (absolute difference of 14.0%, p = .01). Headache was the most common treatment-related adverse event, occurring in 9.0% and 9.4% of millennials and nonmillennials, respectively.

CONCLUSION

A single dose of 20U prabotulinumtoxinA administered for the treatment of glabellar lines was similarly well-tolerated by both millennials and nonmillennials; overall, it was more efficacious in millennials.

摘要

背景

千禧一代越来越多地使用美容产品,但该人群的已发表临床试验数据有限。

目的

比较保妥适治疗千禧一代和非千禧一代中重度皱眉纹的疗效和安全性。

方法和材料

对接受 20U 保妥适治疗的所有患者的汇总人群进行事后分析,这些患者来自 3 项单剂量 III 期皱眉纹临床试验。患者按年龄分组:千禧一代(1982-2000 年出生)与非千禧一代(1981 年及以前出生)。主要疗效终点是 4 分皱眉纹量表上最大皱眉时基线改善≥1 分的应答者比例。还总结了不良事件。

结果

在所有访视中,千禧一代(n=65)的应答率平均比非千禧一代(n=668)高 7.7%;在第 90 天有统计学意义。第 90 天的应答率分别为 90.2%和 76.1%(绝对差异为 14.0%,p=0.01)。头痛是最常见的与治疗相关的不良事件,分别发生在 9.0%和 9.4%的千禧一代和非千禧一代中。

结论

20U 保妥适单剂量治疗皱眉纹在千禧一代和非千禧一代中均具有良好的耐受性;总体而言,在千禧一代中疗效更好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/434f/9154296/d889695c69d0/ds-48-664-g001.jpg

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