Phase 3, Multicenter Open-label Extension Study to Evaluate the Safety 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
- 292
- 试验地点
- 29
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
This is a Phase 3, open-label extension study to evaluate the long-term safety of repeat BOTOX treatments in adult participants with Platysma Prominence. Participants who completed the lead-in Phase 3 Study M21-309 and met eligibility requirements could enroll in this open-label extension study.
Planned study enrollment was approximately 270 participants. Participants who met treatment criteria could receive up to 3 administrations of BOTOX. Day 1 (study entry) was the same day as Day 120/study exit visit of the lead-in Phase 3 study. The first administration of study drug could occur at the Day 1 visit, and the last administration of study drug could occur at the Day 180 visit (60 days prior to Day 240/study exit). Once a subject was enrolled in this study, monthly follow-up visits occurred.
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
- •Completion of all phases of the lead-in Phase 3 study (Screening Period, Treatment Period [randomization/treatment with 4-month follow-up visit] and Study Exit visit)
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
- •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 for up to 3 Cycles during study M21-323
干预措施: OnabotulinumtoxinA (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 371 days (from enrollment in the lead-in study M21-309 through end of study M21-323)
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 casual relationship with this treatment.
次要结局
未报告次要终点