Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Bimatoprost Topical Solution in the Treatment of Androgenetic Alopecia in Men
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Allergan
- 入组人数
- 53
- 试验地点
- 3
- 主要终点
- Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
This is a safety, tolerability, and pharmacokinetics study of bimatoprost in male patients with androgenetic alopecia (AGA).
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
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year
排除标准
- •History of Paget's disease, osteoporosis, or bone malignancy
- •History of bone fracture within the previous 12 months, except for metatarsal, metacarpal, or skull fractures
- •Patient is currently undergoing radiation therapy or anticipates undergoing radiation therapy at any time during the study
- •Drug or alcohol abuse within 12 months
- •HIV positive
- •Received hair transplants or had scalp reductions
- •Use of hair weaves, hair extensions or wigs within 3 months
- •Application of topical medications, minoxidil or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks
研究组 & 干预措施
Cohort 1: Bimatoprost 0.3% (Formulation B)
0.25 mL of bimatoprost 0.3% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days.
干预措施: Bimatoprost (Drug)
Cohort 2: Bimatoprost 1% (Formulation A)
0.25 mL of bimatoprost 1% (Formulation A) applied onto pre-specified area on the scalp once daily for 28 days.
干预措施: Bimatoprost (Drug)
Cohort 2: Bimatoprost 1% (Formulation B)
0.25 mL of bimatoprost 1% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days.
干预措施: Bimatoprost (Drug)
Cohort 3: Bimatoprost 1% (Formulation B)
1 mL of bimatoprost 1% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days.
干预措施: Bimatoprost (Drug)
Cohort 4: Bimatoprost 3% (Formulation B)
1 mL of bimatoprost 3% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days.
干预措施: Bimatoprost (Drug)
结局指标
主要结局
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
时间窗: 42 Days
Change from Baseline in Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale
时间窗: Baseline, 42 Days
Maximum plasma level (Cmax) of bimatoprost and its acid metabolite
时间窗: 31 Days
次要结局
未报告次要终点