Evaluation of Local Pharmacokinetics and Tolerability of Bimatoprost Applied Topically to the Scalp of Male Patients With Androgenetic Alopecia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Drug Concentration in Skin Biopsy Samples
研究概览
简要总结
This study will evaluate the skin pharmacokinetics and tolerability of bimatoprost Formulation A and Formulation B following 14 days of once daily topical administration in male participants with androgenetic alopecia (AGA).
详细描述
Single-center, multiple-dose study evaluting the local pharmacokinetics and tolerability of bimatoprost following 14 days of once daily topical administration of bimatoprost Formulation A and Formulation B (both containing 1% bimatoprost) to the scalp of male patients With androgenetic alopecia
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Patients with mild to moderate Androgenetic Alopecia of the vertex area of the scalp.
排除标准
- •Patients with uncontrolled systemic disease
- •History of significant cardiovascular disease
- •Scarring disease, infection, or abnormality of the scalp or hair shaft or systemic disease that could cause temporary hair loss (eg, seborrheic dermatitis, psoriatic dermatitis, alopecia areata, cicatricial alopecia, uncontrolled hyperthyroidism/hypothyroidism, tinea infections, and genetic disorders)
- •Patients who have received hair transplants or have had scalp reductions
- •Abnormal bone biomarker laboratory results.
研究组 & 干预措施
All Participants
Bimatoprost 1% Formulation A solution applied to the left side of the scalp and trunk area and Bimatoprost 1% Formulation B solution applied to the right side of the scalp and trunk area once daily for 14 days.
干预措施: Bimatoprost 1% Formulation A (Drug)
All Participants
Bimatoprost 1% Formulation A solution applied to the left side of the scalp and trunk area and Bimatoprost 1% Formulation B solution applied to the right side of the scalp and trunk area once daily for 14 days.
干预措施: Bimatoprost 1% Formulation B (Drug)
结局指标
主要结局
Drug Concentration in Skin Biopsy Samples
时间窗: Day 14
Percentage of Participants with at Least 1 Treatment Emergent Adverse Event
时间窗: 28 Days
次要结局
未报告次要终点