A Multicenter, Double-Blind, Randomized, Placebo-Controlled Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of OnabotulinumtoxinA X for the Treatment of Moderate to Severe Glabellar Lines
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 328
- 试验地点
- 18
- 主要终点
- Percentage of Participants With Achievement of ≥ 1-grade Improvement From Baseline as Rated by Investigator Using the Clinician Glabellar Lines Scale.
研究概览
简要总结
This is a Phase 2, dose ranging study to evaluate the safety of OnabotulinumtoxinA X and to compare the efficacy of OnabotulinumtoxinA X and placebo for the treatment of Glabellar Lines in adult participants with moderate to severe GL.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their facial lines, in the opinion of the investigator.
- •Participant has moderate or severe GL at maximum frown.
排除标准
- •History of known immunization to any botulinum toxin serotype.
- •History of known hypersensitivity to any botulinum toxin serotype, or any other constituents of the study drug or its excipients, and/or other products in the same class.
- •Presence or history of any medical condition that may place the participant at increased risk following exposure to OnabotulinumtoxinA X or interfere with the study evaluation, including:
- •Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function.
- •Facial nerve palsy.
- •Infection or dermatological condition at the site of study drug injection.
研究组 & 干预措施
Placebo
Placebo will be injected into the Glabellar Complex on Day 1.
干预措施: Placebo (Drug)
OnabotulinumtoxinA X Dose A
OnabotulinumtoxinA X Dose A will be injected into the Glabellar Complex on Day 1.
干预措施: OnabotulinumtoxinA X (Drug)
OnabotulinumtoxinA X Dose B
OnabotulinumtoxinA X Dose B will be injected into the Glabellar Complex on Day 1.
干预措施: OnabotulinumtoxinA X (Drug)
OnabotulinumtoxinA X Dose C
OnabotulinumtoxinA X Dose C will be injected into the Glabellar Complex on Day 1.
干预措施: OnabotulinumtoxinA X (Drug)
结局指标
主要结局
Percentage of Participants With Achievement of ≥ 1-grade Improvement From Baseline as Rated by Investigator Using the Clinician Glabellar Lines Scale.
时间窗: Day 1 to Day 30
The Clinician Glabellar Lines Scale is a four point scale used to assess the severity of Glabellar Lines at maximum contraction ranging from 0 - None to 3 - Severe
Percentage of Participants With Adverse Events (AEs)
时间窗: Day 1 to Day 270
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
次要结局
- Percentage of Participants With Achievement of None or Mild as Rated by Investigator Using the Clinician Glabellar Lines Scale.(Day 1 to Day 30)
- Percentage of Participants With Achievement of Improvement Per the Facial Lines Satisfaction Questionnaire Impact Domain, Among Subjects With Baseline Scores of 14 Points or Greater.(Day 1 to Day 30)
- Percentage of Participants With Achievement of Satisfaction With Treatment Per the Facial Line Satisfaction Questionnaire Item 5.(Day 1 to Day 60)
