Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 42
- 主要终点
- Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost
研究概览
简要总结
This study will investigate the safety, tolerability, and pharmacokinetics of new formulation of bimatoprost following topical application in patients with alopecia. Two formulations of bimatoprost will be investigated in Part 1 and a third formulation of bimatoprost will be investigated in Part 2. Part 2 will begin after Part 1 has completed.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males with moderate male-pattern baldness (androgenic alopecia)
- •Females with moderate female pattern hair loss
- •Non-smoker or smoker with at least 30 days abstinence from smoking/using nicotine-containing products
排除标准
- •Any dermatological condition of the scalp other than androgenic alopecia (males) or female pattern hair loss (females)
- •Use of bimatoprost or other prostaglandin analogs within 3 months
- •Prior use of scalp hair growth treatment (eg, finasteride, minoxidil) within 6 months
- •Any prior hair growth procedures (eg, hair transplant or laser)
- •Blood donation or equivalent blood loss within 90 days
- •History of alcohol or drug addiction
研究组 & 干预措施
Part 1: bimatoprost Formulation A
bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
干预措施: bimatoprost Formulation A (Drug)
Part 1: bimatoprost Formulation B
bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
干预措施: bimatoprost Formulation B (Drug)
Part 2: bimatoprost Formulation C
bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
干预措施: bimatoprost Formulation C (Drug)
结局指标
主要结局
Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost
时间窗: Day 1
Cmax is the maximum plasma level following a single dose of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended.
Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost
时间窗: 17 Days
Cmax is the maximum plasma level following multiple doses of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended.
次要结局
- Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings(17 Days)
- Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment(Baseline, 20 Days)
- Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment(Baseline, 20 Days)