Safety and Efficacy Study of Bimatoprost in the Treatment of Women With Female Pattern Hair Loss
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 306
- 主要终点
- Change From Baseline in Target Area Hair Count (TAHC)
研究概览
简要总结
This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 2% solution in women with female pattern hair loss. All treatments will be provided in a double-blinded fashion except for minoxidil 2% solution which will be provided open-label.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate female pattern hair loss with ongoing hair loss for at least 1 year
- •Willingness to have micro-dot-tattoo applied to scalp
- •Willingness to maintain same hair style, length and hair color during study
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
- •Oral or topical minoxidil treatment within 6 months
- •Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks
研究组 & 干预措施
bimatoprost Formulation A
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
干预措施: bimatoprost Formulation A (Drug)
bimatoprost Formulation B
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
干预措施: bimatoprost Formulation B (Drug)
bimatoprost Formulation C
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
干预措施: bimatoprost Formulation C (Drug)
bimatoprost vehicle solution
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
干预措施: bimatoprost vehicle solution (Drug)
minoxidil 2% solution
Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
干预措施: minoxidil 2% solution (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). 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: Baseline, 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(Baseline, Month 6)
- Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score(Baseline, 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)