Study of Bimatoprost Solution in Increasing Eyelash Prominence in African Americans With Eyelash Hypotrichosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 89
- 主要终点
- Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4
研究概览
简要总结
This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily to the upper eyelid margins (where the eyelashes meet the skin) compared with vehicle in increasing overall eyelash prominence in self-identified African American/ethnic black subjects exhibiting hypotrichosis of the eyelashes (inadequate or not enough eyelashes).
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
- •African American/ethnic black
- •Adults at least 18 years of age
- •Eyelash prominence assessment of minimal or moderate
排除标准
- •Subjects with uneven lashes or longer on one side than the other
- •Any eye disease or abnormality
- •Eye surgery
- •Severe hyperpigmentation around the eye
- •Eyelash implants
- •Eyelash extension application
- •Any use of eyelash growth products within 6 months
- •Any use of prescription eyelash growth products
- •Treatments that may affect hair growth
- •Requiring eye drop medications for glaucoma
研究组 & 干预措施
LATISSE®
bimatoprost ophthalmic 0.03% solution
干预措施: bimatoprost ophthalmic 0.03% solution (Drug)
Placebo
vehicle sterile solution
干预措施: vehicle sterile solution (placebo) (Drug)
结局指标
主要结局
Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4
时间窗: Month 4
Percentage of treatment responders in overall eyelash prominence, defined as at least a 1-grade improvement from baseline at Month 4 in the Global Eyelash Assessment (GEA) Scale. The GEA is a 4-point scale in which eyelash prominence is assessed from 1 (minimal prominence) to 4 (very marked prominence).
次要结局
未报告次要终点