Abstract：
Botulinum toxin type A (BoNT-A) was first isolated in 1946, and since then, several formulations have been developed and widely used to treat wrinkles by inducing muscle paralysis. This multicenter, double-blind, randomized, parallel-group, active-controlled phase 3 clinical trial was designed to evaluate the efficacy and safety of a newly developed BoNT-A formulation, BMI2006, in improving moderate to severe glabellar wrinkles and to compare with existing onabotulinumtoxin A (OBoNT) injections. A total of 276 subjects were enrolled and received 20 units of the randomized material, which was intramuscularly injected into five different locations on the forehead. The primary endpoint, assessed at 4 weeks, showed no statistically significant difference in the improvement rate of glabellar wrinkles between the two groups, with BMI2006 demonstrating non-inferiority to comparator BoNT-A. Secondary endpoints, evaluated by both treating investigators and independent investigators, also exhibited similar improvement rates throughout the study period. Both groups reported high levels of satisfaction with no statistical difference between the two groups. Safety evaluations indicated mild and transient adverse events, with no serious reactions observed. In conclusion, BMI2006 is an effective and safe BoNT-A for treating glabellar wrinkles with an expected duration of action between 8 and 12 weeks.
摘要：
A型肉毒杆菌毒素(BoNT-A)于1946年首次分离,已经开发了几种配方，并广泛用于通过诱导肌肉麻痹来治疗皱纹。这个多中心，双盲,随机化，平行组，主动控制3期临床试验旨在评估新开发的BoNT-A制剂的疗效和安全性，BMI2006，用于改善中度至重度的眉间皱纹，并与现有的单乳毒素A（OBoNT）注射进行比较。共纳入276名受试者，并接受了20个单位的随机材料，肌肉注射到额头的五个不同位置。主端点，在4周评估，差异无统计学意义,BMI2006证明了对比较器BoNT-A的非劣效性。次要终点,由治疗研究者和独立研究者评估，在整个研究期间也表现出相似的改善率。两组均报告了较高的满意度，两组之间无统计学差异。安全性评价显示轻度和短暂的不良事件，没有观察到严重的反应。总之,BMI2006是一种有效且安全的BoNT-A，用于治疗眉间皱纹，预期作用时间在8到12周之间。
