A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Platysma Prominence
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 426
- 试验地点
- 34
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The purpose of the study is to evaluate the safety and effects of onabotulinumtoxinA (BOTOX) for the temporary improvement in the appearance of platysma prominence.
Study doctors will randomize participants into 1 of the 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 400 participants will be enrolled in the study across approximately 35 sites in USA, Belgium, Canada, Germany and the UK.
Participants will receive a single treatment of intramuscular injection of onabotulinumtoxinA (BOTOX) or placebo on Day 1 during this 4 month long study.
Participants will attend regular monthly visits during the study at the study site.
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
- Triple (Participant, 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
- •Participants must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study specific procedures
- •Are willing and able to comply with procedures required in the protocol
- •Adult male or female, at least 18 years old at the time of signing the informed consent
- •Good health as determined by medical history, physical examination, vital signs, and investigator's judgment
排除标准
- •Any medical condition that may put the participant at increased medical risk with exposure to BOTOX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
- •Participant has an anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study intervention)
- •Anticipated need for surgery or overnight hospitalization during the study
- •Females who are pregnant or breastfeeding and are considering becoming pregnant or donating eggs during the study
- •Known immunization or hypersensitivity to any botulinum toxin serotype
- •History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months
- •Lower facial and neck hair, scarring (e.g., acne), or other abnormal variations that may interfere with photography (such that photograph is not acceptable)
- •Tattoos, jewelry, or clothing that cannot be removed, and that obscure the target area of interest
研究组 & 干预措施
BOTOX
BOTOX (OnabotulinumtoxinA) will be injected into the platysma muscle on Day 1
干预措施: OnabotulinumtoxinA (Drug)
Placebo
Placebo will be injected into the platysma muscle on Day 1
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: Enrollment to Day 120
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.
Achievement of at Least a 2-grade Improvement From Baseline Based on the Investigator's Assessment Using C-APPS at Maximum Contraction at Day 14
时间窗: Day 14
The C-APPS evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme.
Composite Achievement of Grade 1 or 2 (Minimal or Mild) and at Least a 2-Grade Improvement From Baseline Based on Both Investigator's Assessment Using C-APPS and Participant's Self-Assessment Using P-APPS, at Maximum Contraction at Day 14
时间窗: Day 14
The Clinician Allergan Platysma Prominence Scale (C-APPS) evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme. The Participant Allergan Platysma Prominence Scale (P-APPS) evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.
Achievement of at Least a 2-grade Improvement From Baseline Based on the Participant's Self-Assessment Using P-APPS at Maximum Contraction at Day 14
时间窗: Day 14
The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.
次要结局
- Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120(Day 14, 30, 60, 90, and 120)
- Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Participant's Self-Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120(Day 14, 30, 60, 90, and 120)
- Percentage of Participants With Responses of "Satisfied" or "Very Satisfied" on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14(Day 14)
- Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the Bother Assessment Scale - Platysma Prominence (BAS-PP) Scale Item 2 (Jawline) at Day 14(Day 14)
- Change From Baseline on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts Summary Score at Day 14(Day 14)
- Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120(Day 14, 30, 60, 90, and 120)
- Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 1 (Vertical Neck Bands) at Day 14(Day 14)
- Percentage of Participants With Responses of "Satisfied" or "Very Satisfied" on the ANLFQ: Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14(Day 14)
- Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 2 (Jawline) at Day 14(Day 14)
- Change From Baseline on the ANLFQ: Impacts Summary Score at Days 30, 60, and 90(Days 30, 60, and 90)
- Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120(Day 14, 30, 60, 90, and 120)
- Percentage of Participants Who Achieved a Rating of Minimal or Mild According to Participant's Assessment Using P-APPS at Maximum Contraction at Days 14(Day 14)