Imhof Matthias, Kühne Ulrich
Ästhetische Dermatologie, Medico Palais Bad Soden, Bad Soden, Germany.
J Clin Aesthet Dermatol. 2011 Oct;4(10):28-34.
To investigate the efficacy and safety of incobotulinumtoxinA (also known as botulinum toxin type A [150 kDa], free from complexing proteins, or previously as NT 201), for the treatment of glabellar frown lines, in a prospective, open-label, multicenter, Phase III trial.
The study was a prospective, open-label, multicenter, international, Phase III clinical study. Subjects with moderate-to-severe glabellar frown lines at maximum frown, as assessed by the investigator according to the facial wrinkle scale, were given one intramuscular treatment of 20U incobotulinumtoxinA, administered as 0. 1mL to each of five injection sites, and assessed over 84 days. Missing values were imputed using the baseline value or next observation carried backwards. Adverse events were documented for the duration of the study.
Two centers in Russia and one center in Germany.
A total of 105 subjects (18-65 years) with moderate-to-severe glabellar frown lines at maximum frown were enrolled.
The primary endpoint was the percentage of responders at maximum frown (improvement of ≥1 on the facial wrinkle scale when compared with Day 0) on Day 28, as assessed by the investigator.
Response to treatment with incobotulinumtoxinA with respect to the facial wrinkle scale at maximum frown on Day 28 and Day 84 was 98.1 and 80.0 percent, respectively (missing values imputed). At rest, 94.3 percent (imputed values) of subjects were responders on Day 28 while 81.9 percent were responders on Day 84 (imputed values). Consistent with assessment by the investigators, subjects also rated treatment success highly. Incidence of treatment-related adverse events was low and no patients developed neutralizing antibodies.
IncobotulinumtoxinA is effective in the treatment of glabellar frown lines and is well tolerated.
在一项前瞻性、开放标签、多中心III期试验中，研究注射用A型肉毒毒素（也称为150 kDa A型肉毒毒素，不含复合蛋白，以前称为NT 201）治疗眉间皱纹的有效性和安全性。
该研究为前瞻性、开放标签、多中心、国际性III期临床研究。根据面部皱纹量表，由研究者评估为最大皱眉时中度至重度眉间皱纹的受试者接受一次20U注射用A型肉毒毒素的肌肉注射治疗，以0.1mL注射至五个注射部位中的每一个，并进行84天的评估。缺失值采用基线值或向后延续的下一次观察值进行插补。在研究期间记录不良事件。
俄罗斯的两个中心和德国的一个中心。
共招募了105名年龄在18 - 65岁之间、最大皱眉时具有中度至重度眉间皱纹的受试者。
主要终点是在第28天由研究者评估的最大皱眉时的应答者百分比（与第0天相比，面部皱纹量表改善≥1）。
在第28天和第84天，注射用A型肉毒毒素治疗对最大皱眉时面部皱纹量表的应答率分别为98.1%和80.0%（插补缺失值）。在静息状态下，第28天94.3%（插补值）的受试者为应答者，第84天为81.9%（插补值）。与研究者的评估一致，受试者对治疗成功的评价也很高。治疗相关不良事件的发生率较低，且没有患者产生中和抗体。
注射用A型肉毒毒素治疗眉间皱纹有效且耐受性良好。
