Department of Clinical Research, Research Institute of the Southeast, West Palm Beach, Florida.
ATS Clinical Research, Santa Monica, California.
Dermatol Surg. 2019 Nov;45(11):1381-1393. doi: 10.1097/DSS.0000000000001903.
PrabotulinumtoxinA is a 900-kDa botulinum toxin Type A produced by Clostridium botulinum.
To investigate the efficacy and safety of prabotulinumtoxinA for the treatment of glabellar lines.
Adult subjects (n = 330 in EV-001; n = 324 in EV-002) with moderate to severe glabellar lines at maximum frown on the 4-point Glabellar Line Scale (GLS; 0 = no lines, 1 = mild, 2 = moderate, and 3 = severe) were enrolled in 1 of 2 identical 150-day, double-blind, placebo-controlled, single-dose, Phase III studies. Subjects were randomized 3:1 to receive 20-U prabotulinumtoxinA or placebo. The primary efficacy end point was the proportion of responders on Day 30 where the investigator and subject independently agreed that a ≥2-point improvement had occurred on the GLS at maximum frown from Day 0. Adverse events (AEs) were evaluated throughout the study.
Responder rates in the prabotulinumtoxinA and placebo groups were 67.5% and 1.2% in EV-001 and 70.4% and 1.3% in EV-002; absolute differences between groups were 66.3% and 69.1% in EV-001 and EV-002, respectively (both p < .001). No serious AE in either study was assessed as study drug related.
In these studies, a single dose of 20-U prabotulinumtoxinA was safe and effective for the treatment of glabellar lines.
PrabotulinumtoxinA 是由肉毒梭菌产生的 900kDa 型肉毒毒素 A。
研究 PrabotulinumtoxinA 治疗眉间纹的疗效和安全性。
在两项为期 150 天、双盲、安慰剂对照、单次剂量、III 期研究中，共纳入 330 名（EV-001 组）和 324 名（EV-002 组）中度至重度眉间纹（在 4 分眉间纹量表 [GLS] 上最大皱眉时，0 分为无皱纹，1 分为轻度，2 分为中度，3 分为重度）的成年受试者。受试者按 3:1 的比例随机分组，分别接受 20U PrabotulinumtoxinA 或安慰剂治疗。主要疗效终点是第 30 天应答者比例，即研究者和受试者独立评估最大皱眉时 GLS 较基线至少改善 2 分。评估整个研究过程中的不良事件（AE）。
在 EV-001 组和 EV-002 组中，PrabotulinumtoxinA 组和安慰剂组的应答率分别为 67.5%和 1.2%和 70.4%和 1.3%；两组间的绝对差值分别为 66.3%和 69.1%（均<0.001）。在两项研究中，均无严重 AE 被评估为与研究药物相关。
在这些研究中，单次 20U 的 PrabotulinumtoxinA 治疗眉间纹安全有效。
