A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 244
- 主要终点
- Change From Baseline in Target Area Hair Count (TAHC)
研究概览
简要总结
This is a safety and efficacy study of bimatoprost in male subjects with androgenic 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
- Triple (Participant, Care Provider, Investigator)
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
- •Willingness to maintain same hair style, length and hair color during study
- •Willingness to have micro-dot-tattoo applied to scalp (Stage 2 only)
排除标准
- •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
- •Use of minoxidil (oral or topical) and/or low level light treatment "combs" for hair growth within the last 6 months, or expected use during the study
- •Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks
研究组 & 干预措施
Stage 1: Bimatoprost Solution 1 Twice Daily
Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
干预措施: Bimatoprost Solution 1 (Drug)
Stage 1: Bimatoprost Solution 1 Once Daily
Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
干预措施: Bimatoprost Solution 1 (Drug)
Stage 1: Bimatoprost Solution 1 Once Daily
Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
干预措施: Bimatoprost Vehicle (Drug)
Stage 1: Bimatoprost Solution 2 Twice Daily
Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
干预措施: Bimatoprost Solution 2 (Drug)
Stage 1: Bimatoprost Solution 2 Once Daily
Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
干预措施: Bimatoprost Solution 2 (Drug)
Stage 1: Bimatoprost Solution 2 Once Daily
Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
干预措施: Bimatoprost Vehicle (Drug)
Stage 2: Bimatoprost Solution 1 Twice Daily
Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
干预措施: Bimatoprost Solution 1 (Drug)
Stage 2: Bimatoprost Solution 2 Twice Daily
Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
干预措施: Bimatoprost Solution 2 (Drug)
Stage 2: Bimatoprost Vehicle Twice Daily
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
干预措施: Bimatoprost Vehicle (Drug)
结局指标
主要结局
Change From Baseline in Target Area Hair Count (TAHC)
时间窗: Baseline, Month 6
TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm\^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the number of terminal hairs).
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
时间窗: Month 6
The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: "Since the start of the study, the amount of my hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.
次要结局
- Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score(Month 6)
- Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score(Month 6)
- Change From Baseline in Target Area Hair Width (TAHW)(Baseline, Month 6)
- Change From Baseline in Target Area Hair Darkness (TAHD)(Baseline, Month 6)