Rosenpark Klinik, Darmstadt, Germany.
Dermatol Surg. 2010 Dec;36 Suppl 4:2146-54. doi: 10.1111/j.1524-4725.2010.01706.x.
Use of botulinum toxin for esthetic purposes has rapidly expanded over the last 20 years. IncobotulinumtoxinA, also known as NT 201, is a new botulinum toxin type A (150 kDa) that is free from complexing proteins.
A prospective, multicenter, randomized, rater- and patient-blind, international Phase III trial to investigate the noninferiority of incobotulinumtoxinA to another botulinum toxin type A, onabotulinumtoxinA, in the treatment of glabellar frown lines.
A total of 381 patients were randomized in a 3:1 (incobotulinumtoxinA:onabotulinumtoxinA) ratio to receive 24 U incobotulinumtoxinA of or onabotulinumtoxinA. Efficacy end points included the percentage of responders (patients with an improvement of ≥1 point on a 4-point facial wrinkle scale) at maximum frown at weeks 4 and 12 as assessed by the investigators, and a panel of independent raters based on standardized digital photographs.
Four weeks after injection, response rates at maximum frown were 96.4% in the incobotulinumtoxinA group and 95.7% in the onabotulinumtoxinA group as assessed by independent raters. Analysis of the data confirmed the noninferiority of incobotulinumtoxinA. Response rates at rest were lower for both products. The rate of adverse events was low.
IncobotulinumtoxinA is equally as effective as onabotulinumtoxinA in the treatment of glabellar frown lines. Both preparations were well tolerated.
在过去的 20 年中，出于美容目的而使用肉毒毒素的情况迅速增加。 新型肉毒毒素 A（IncobotulinumtoxinA，也称为 NT 201）是一种不含复合蛋白的新型肉毒毒素 A（150 kDa）。
一项前瞻性、多中心、随机、盲法（评价者和患者）、国际 III 期试验，旨在研究 IncobotulinumtoxinA 与另一种肉毒毒素 A（onabotulinumtoxinA）在治疗眉间竖纹中的非劣效性。
总共 381 例患者按 3:1（IncobotulinumtoxinA:onabotulinumtoxinA）的比例随机分组，分别接受 24 U IncobotulinumtoxinA 或 onabotulinumtoxinA。疗效终点包括在最大皱眉时的应答率（根据 4 分面部皱纹量表评估，患者改善≥1 分的比例），由研究者和一组独立的评价者在第 4 周和第 12 周评估。
在注射后 4 周时，最大皱眉时的应答率在 IncobotulinumtoxinA 组和 onabotulinumtoxinA 组分别为 96.4%和 95.7%，由独立评价者评估。数据分析证实了 IncobotulinumtoxinA 的非劣效性。两种产品在休息时的应答率均较低。不良事件的发生率较低。
IncobotulinumtoxinA 治疗眉间竖纹的效果与 onabotulinumtoxinA 相当。两种制剂均具有良好的耐受性。
