Phase 1b Safety and Tolerability of Intradermal BOTOX® (OnabotulinumtoxinA) Purified Neurotoxin Complex in Participants With Facial Fine Lines
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 172
- 试验地点
- 5
- 主要终点
- Number of Participants with Adverse Events (AEs)
研究概览
简要总结
The main objective of this study is to assess safety and tolerability of Intradermal (ID) BOTOX in participants with facial fine 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A female participant must be willing to minimize the risk of inducing pregnancy for the duration of the clinical study (eg, for at least 90 days after receiving study intervention).
- •Participant must have sufficient visual acuity without the use of eyeglasses (contact lans use acceptable) to accurately assess their facial lines, in the opinion of the investigator.
- •Participant must be in good health as determined by medical history, physical examination, vital signs, and investigator's judgment, including no known active COVID-19 infection.
- •Be nonsmoking and a nonuser of cannabis and nicotine-containing products, or have not smoked or used cannabis or nicotine-containing products, including e-cigarettes, within the previous 2 years.
排除标准
- •Known immunization or hypersensitivity to any botulinum toxin serotype.
- •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.
- •Rosacea, skin infection, or any other skin disease or disorder that would represent a safety concern and/or interfere with the ability to either administer treatment or assess the treatment effect, as determined by the investigator.
研究组 & 干预措施
Open Label BOTOX
Participants will receive BOTOX at Baseline (Day 1)
干预措施: Botox (Drug)
Double-Blind Randomized BOTOX
Participants will receive BOTOX at Baseline (Day 1)
干预措施: Botox (Drug)
Double Blind Randomized Placebo
Participants will receive placebo at Baseline (Day 1)
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs)
时间窗: Baseline (Day 1) to Final Visit (up to Day 97)
Unique number of participants who experience one or more treatment emergent adverse event
Number of Participants with Potential Clinically Significant (PCS) changes in vital signs
时间窗: Baseline (Day 1) to Final Visit (up to Day 97)
Unique number of participants who experience one or more Potential Clinically Significant (PCS) change in vital signs from the Baseline visit.
Number of Participants with Potential Clinically Significant (PCS) changes in physical exams
时间窗: Baseline (Day 1) to Final Visit (up to Day 97)
Unique number of participants who experience one or more Potential Clinically Significant (PCS) change in physical exams from the Baseline visit.
Number of Participants with injection site pain/discomfort.
时间窗: Baseline (Day 1)
Unique number of participants who experience injection site pain and/or discomfort at the injection site during administration of treatment.
次要结局
未报告次要终点