relabotulinumtoxa液体肉毒毒素治疗侧眦线的有效性和安全性：来自3 -2期研究的结果。

IF 2.5 3区医学 Q2 DERMATOLOGY

Dermatologic Surgery Pub Date : 2024-12-18 DOI:10.1097/DSS.0000000000004470

Glynis Ablon, David Bank, Theda C Kontis, Sherrif F Ibrahim, Melanie Palm, Sue Ellen Cox, Jason K Rivers, Lisa Grunebaum, Mitchel P Goldman, Shannon Humphrey, Sarah Coquis-Knezek

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引用次数: 0

摘要

背景：RelabotulinumtoxinA （RelaBoNT-A）是一种无络合物、即用型液体肉毒毒素a。目的：RelaBoNT-A治疗侧眦线（LCL）的疗效/安全性。方法：随机成人接受RelaBoNT-A (30 U/侧；n = 230)或安慰剂（n = 73）进行为期6个月的双盲Ph3研究（relabotulintoxin Aesthetic Development study -2 [READY-2]）。主要终点（第1个月，最大微笑）包括：使用LCL严重程度研究者实时评估（LCL- ila）和受试者实时评估（LCL- sla）的复合≥2级应答率；LCL-ILA 0（无）/1（轻度）应答率。受试者满意度和不良事件也有报告。结果：第1个月复合≥2级应答率为51.8% （RelaBoNT-A）和1.4%(安慰剂；（p < 0.001）。第1个月无/轻度ldl - ila应答率为87.2% （RelaBoNT-A）和11.9%(安慰剂；P < 0.001)。第1天发病率为34%。在第6个月，RelaBoNT-A的LCL-ILA应答率保持在23.3%（无/轻度）和35.9%（≥1级改善）。恢复到基线严重程度的中位数为24.7周；在第6个月时，64% （RelaBoNT-A组）未恢复到基线水平。RelaBoNT-A满意度在第6个月很高（71%）。轻度/中度治疗相关不良事件发生率分别为6.1% （RelaBoNT-A）和5.5%（安慰剂）。结论：RelaBoNT-A （60 U）治疗可显著改善中重度LCL。三分之一的受试者报告在1天内发病，改善持续到第6个月。治疗满意度高。RelaBoNT-A耐受性良好。

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Efficacy and Safety of RelabotulinumtoxinA Liquid Botulinum Toxin in the Treatment of Lateral Canthal Lines: Results From the Phase 3 READY-2 Study.

Background: RelabotulinumtoxinA (RelaBoNT-A) is a complex-free, ready-to-use, liquid botulinum toxin A.

Objective: Efficacy/safety of RelaBoNT-A treatment for lateral canthal lines (LCL).

Methods: Randomized adults received RelaBoNT-A (30 U/side; n = 230) or placebo (n = 73) during a 6-month, double-blind, Ph3 study (Relabotulinumtoxin Aesthetic Development Study-2 [READY-2]). Primary end points (Month 1, maximum smile) comprised: composite ≥2-grade responder rate using concurrent LCL severity investigator live assessment (LCL-ILA) and subject live assessment (LCL-SLA); LCL-ILA 0 (none)/1 (mild) responder rate. Subject satisfaction and adverse events were also reported.

Results: Month 1 composite ≥2-grade responder rates were 51.8% (RelaBoNT-A) and 1.4% (placebo; (p < .001). Month 1 none/mild LCL-ILA responder rates were 87.2% (RelaBoNT-A) and 11.9% (placebo; p < .001). Onset was reported Day 1 by 34%. At Month 6, LCL-ILA responder rates for RelaBoNT-A remained at 23.3% (none/mild) and 35.9% (≥1-grade improvement). Median return to baseline severity was 24.7 weeks; 64% (RelaBoNT-A group) had not returned to baseline at Month 6. RelaBoNT-A satisfaction was high through Month 6 (71%). Mild/moderate treatment-related adverse events occurred in 6.1% (RelaBoNT-A) and 5.5% (placebo).

Conclusion: RelaBoNT-A (60 U) treatment provided statistically significant improvement of moderate-to-severe LCL. One-third of subjects reported onset within 1 day and improvements were maintained through Month 6. Treatment satisfaction was high. RelaBoNT-A was well tolerated.

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来源期刊

Dermatologic Surgery 医学-皮肤病学

CiteScore

3.10

自引率

16.70%

发文量

547

期刊介绍： Exclusively devoted to dermatologic surgery, the Dermatologic Surgery journal publishes the most clinically comprehensive and up-to-date information in its field. This unique monthly journal provides today’s most expansive and in-depth coverage of cosmetic and reconstructive skin surgery and skin cancer through peer-reviewed original articles, extensive illustrations, case reports, ongoing features, literature reviews and correspondence. The journal provides information on the latest scientific information for all types of dermatologic surgery including: -Ambulatory phlebectomy- Blepharoplasty- Body contouring- Chemical peels- Cryosurgery- Curettage and desiccation- Dermabrasion- Excision and closure- Flap Surgery- Grafting- Hair restoration surgery- Injectable neuromodulators- Laser surgery- Liposuction- Microdermabrasion- Microlipoinjection- Micropigmentation- Mohs micrographic surgery- Nail surgery- Phlebology- Sclerotherapy- Skin cancer surgery- Skin resurfacing- Soft-tissue fillers. Dermatologists, dermatologic surgeons, plastic surgeons, oculoplastic surgeons and facial plastic surgeons consider this a must-read publication for anyone in the field.