Department of Dermatology, Konkuk University School of Medicine, Seoul, Korea.
Daewoong Pharmaceutical Co., Ltd., Seoul, Korea.
Dermatol Surg. 2019 Dec;45(12):1610-1619. doi: 10.1097/DSS.0000000000001920.
Prabotulinumtoxin A has been shown to have efficacy for the treatment of upper-limb spasticity and improvement of moderate to severe glabellar lines. However, the efficacy and safety of prabotulinumtoxin A for crow's feet have not been evaluated.
This study compared the efficacy and safety of prabotulinumtoxin A and onabotulinumtoxin A in the treatment of crow's feet.
A multicenter, randomized, double-blind, active-controlled, split-face study was conducted in subjects with bilateral symmetric, moderate to severe crow's feet at maximum smile. The investigators assessed the severity of crow's feet by using the facial wrinkle scale, and the subjects reported the improvement in severity, their subjective satisfaction, and perceived age. The primary efficacy outcome was the proportion of subjects with Grade 0 or 1 severity of crow's feet at maximum smile at Week 4 as assessed by the investigators.
In the primary efficacy outcome assessment, there was no significant difference between the 2 groups (prabotulinumtoxin A, 65.02%; onabotulinumtoxin A, 62.56%; p = .0956). All secondary efficacy outcomes were also achieved. Adverse events related to injection were mild and recovered spontaneously.
Prabotulinumtoxin A and onabotulinumtoxin A have comparable efficacy and safety in the treatment of crow's feet.
已证实肉毒梭菌神经毒素 A 可有效治疗上肢痉挛，改善中重度眉间纹。然而，尚未评估肉毒梭菌神经毒素 A 治疗鱼尾纹的疗效和安全性。
本研究比较了肉毒梭菌神经毒素 A 和肉毒毒素 A 治疗鱼尾纹的疗效和安全性。
在最大微笑时双侧对称存在中重度鱼尾纹的患者中开展了一项多中心、随机、双盲、阳性对照、左右侧对照的研究。研究者采用面部皱纹量表评估鱼尾纹的严重程度，患者报告严重程度改善情况、自身满意度和感知年龄。主要疗效结局为研究者评估的最大微笑时鱼尾纹严重程度为 0 级或 1 级的患者比例。
在主要疗效结局评估中，两组间无显著差异（肉毒梭菌神经毒素 A 组 65.02%，肉毒毒素 A 组 62.56%，p =.0956）。所有次要疗效结局也均达到。与注射相关的不良事件为轻度，且可自发恢复。
肉毒梭菌神经毒素 A 和肉毒毒素 A 治疗鱼尾纹的疗效和安全性相当。
