Bimatoprost for the Treatment of Eyebrow Hypotrichosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 357
- 主要终点
- Percentage of Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale
研究概览
简要总结
This study will evaluate the safety and efficacy of bimatoprost solution compared with vehicle in the treatment of eyebrow hypotrichosis (inadequate eyebrows).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants with eyebrow hypotrichosis (inadequate eyebrow growth).
排除标准
- •Patients with disease, infection, or abnormality of the eyebrow area
- •Patients with permanent eyebrow loss due to over-grooming
研究组 & 干预措施
Bimatoprost Solution BID
Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
干预措施: bimatoprost solution (Drug)
Bimatoprost Solution QD
Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
干预措施: bimatoprost solution (Drug)
Bimatoprost Solution QD
Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
干预措施: Vehicle to bimatoprost solution (Drug)
Vehicle to Bimatoprost Solution BID
Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
干预措施: Vehicle to bimatoprost solution (Drug)
结局指标
主要结局
Percentage of Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale
时间窗: Baseline, Month 7
The physician evaluated eyebrow fullness using the 4-point GEBA Scale where: 1=very sparse, 2=sparse, 3=full and 4=very full. The percentage of participants with at least a 1-grade increase from Baseline is reported.
次要结局
- Change From Baseline in Eyebrow Darkness as Measured Using DMSIA(Baseline, Month 7)
- Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA)(Baseline, Month 7)
- Percentage of Participants With 'Very Satisfied' or 'Mostly Satisfied' in Eyebrow Satisfaction Scale (ESS) Item #6(Month 7)