Song Sinyoung, Lee Yeon Hoon, Hong Joon Pio, Oh Tae Suk
Department of Plastic and Reconstructive Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Arch Craniofac Surg. 2018 Sep;19(3):168-174. doi: 10.7181/acfs.2018.01886. Epub 2018 Sep 20.
Safety, efficacy, and time to onset of effect of botulinum toxin type A is of importance to persons who seek improvement in glabellar frown lines, but this has not been well studied. The aim of this study was to determine the safety, efficacy, and onset of action of a newly developed botulinum toxin type A (Nabota) for the treatment of glabellar frown lines.
This was a single-arm, open-label, and phase 4 clinical study. Forty-two subjects with glabellar lines were treated with five times of intramuscular injection of 0.1 mL (4 U/0.1 mL) for a total of 20 U of Nabota. Efficacy and safety were assessed at 2, 3, 4, 5, and 14 days. Efficacy was assessed by the investigator and it was defined as a 1-point change on a 4-point scale.
Improvement in glabellar frown lines at maximum frown was observed in 85.4% of subjects 2 days after administration. Improvement in glabellar lines at rest was observed in 51.2% of subjects 2 days after administration, and the proportion of subjects showing improvement increased with time. No severe adverse events were recorded.
Onset of action was observed in the majority of subjects by 2 days after administration of Nabota. In addition, Nabota was found to be safe and effective for the treatment of glabellar frown lines.
A型肉毒毒素的安全性、有效性及起效时间对于寻求改善眉间皱纹的人来说至关重要，但这方面尚未得到充分研究。本研究的目的是确定一种新开发的A型肉毒毒素（Nabota）治疗眉间皱纹的安全性、有效性及作用起效时间。
这是一项单臂、开放标签的4期临床研究。42例有眉间纹的受试者接受了5次肌肉注射，每次0.1 mL（4 U/0.1 mL），共注射20 U的Nabota。在第2、3、4、5和14天评估疗效和安全性。疗效由研究者评估，定义为4分制量表上1分的变化。
给药后2天，85.4%的受试者在最大皱眉时眉间皱纹有所改善。给药后2天，51.2%的受试者在静息时眉间纹有所改善，且随着时间推移，改善的受试者比例增加。未记录到严重不良事件。
在大多数受试者中，Nabota给药后2天观察到起效。此外，发现Nabota治疗眉间皱纹安全有效。
