NCT03004248已完成3 期
An Open-Label, Multi-Center Trial to Assess the Safety of Single and Repeat Treatments of DaxibotulinumtoxinA for Injection for Treatment of Moderate to Severe Glabellar Lines (SAKURA OPEN-LABEL SAFETY)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,691
- 试验地点
- 61
- 主要终点
- Incidence of Treatment Emergent Adverse Events (TEAE)
研究概览
简要总结
This is a long term safety study of DaxibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar lines following single and repeat administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent including authorization to release health information
- •Moderate (2) or severe (3) glabellar lines during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale
- •Moderate (2) or severe (3) glabellar lines during maximum frown based on the Patient Frown Wrinkle Severity (PFWS) scale
- •Willing and able to follow all trial procedures, attend all scheduled visits, and successfully complete the trial
排除标准
- •Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
- •Active skin disease, infections or inflammation at the injection sites
- •Plan to receive botulinum toxin type A anywhere in the face through the duration of the study
- •History of allergy or sensitivity to any botulinum toxin preparations or to any component of the test article
- •Current enrollment in an investigational drug or device trial or participation in such a trial within the last 30 days prior to screening through end of trial
结局指标
主要结局
Incidence of Treatment Emergent Adverse Events (TEAE)
时间窗: 0-36 weeks
Incidence rates based on the number and percentage of subjects treated within each cycle who report Adverse Events (AEs) at anytime following study treatment. Note that subjects could receive up to 3 consecutive treatments during the 36-week follow up period.
次要结局
- The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group(0-36 weeks per Cycle 1 and 2)
- Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales(Week 4)
- The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group(0-36 weeks per cycles 1 and 2)
研究者
研究点 (61)
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