The Treatment of Glabellar Frown Lines
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 10
- 主要终点
- Efficacy, Measured as the Percentage of Participants Who Responded to Treatment
研究概览
简要总结
The purpose of this study is to show that two FDA-approved botulinum toxin drugs called Xeomin® and Botox® can reduce the severity of vertical lines (wrinkles) that appear between the eyebrows (glabellar frown lines).
详细描述
This is a prospective, multicenter, randomized, double-blind, parallel group clinical study to investigate the equivalence of incobotulinumtoxinA (Xeomin®) to onabotulinumtoxinA (Botox®) in the treatment of glabellar frown lines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Outpatient females 18 to 50 years of age
- •Moderate to severe glabellar frown lines
排除标准
- •Glabellar Frown Lines at rest rating 3 on the 4-point Facial Wrinkle Scale
- •Previous treatment with botulinum toxin
- •Previous treatment with biodegradable fillers in glabellar area within last 12 months
- •Any severe or uncontrolled systemic disease, malignant tumor, or medical history of HIV infection
- •Known hypersensitivity to incobotulinumtoxinA or onabotulinumtoxinA or to any of their excipients
- •Intake of any of the forbidden concomitant medication or other agents that might interfere with neuromuscular function or might interfere with the action of botulinum toxin type within 14 days prior to injection
研究组 & 干预措施
IncobotulinumtoxinA
20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points
干预措施: IncobotulinumtoxinA (Drug)
OnabotulinumtoxinA
20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points
干预措施: OnabotulinumtoxinA (Drug)
结局指标
主要结局
Efficacy, Measured as the Percentage of Participants Who Responded to Treatment
时间窗: 1 Month from baseline
Response defined as ≥ 1 point improvement from baseline (prior to treatment) on the Facial Wrinkle Scale at maximum frown as rated by an independent masked panel of physicians specifically qualified to assess study photographs using subject photographs at 1 month from treatment.
次要结局
- Response at Maximum Frown Rated by Independent Rater(4 months from baseline)
- Response at Maximum Frown Rated by Treating Physician(4 months from baseline)
- Subject Satisfaction(4 months from baseline)
- Subject Perception of Treatment Onset(Open-ended time frame for the 4 month study duration. Data for onset and peak effect is recorded in the subject diary.)
- Subject Perception of Treatment Peak Effect(Open-ended time frame for the 4 month study duration. Data for onset and peak effect is recorded in the subject diary.)