A Multicenter, Double-masked, Randomized, Parallel-group Study Assessing the Safety and Efficacy of Once-daily Application of Bimatoprost Solution 0.03% Compared to Vehicle to Treat Chemotherapy-induced Hypotrichosis of the Eyelashes in Japanese Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 36
- 主要终点
- Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)
研究概览
简要总结
This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with vehicle in Japanese adults with hypotrichosis of the eyelashes following chemotherapy treatment.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have inadequate eyelashes due to chemotherapy treatment
- •Treated for solid tumors such as breast or colorectal cancer in early stages where the cancer has not spread outside the primary organ (eg, stage 1, 2 or 3a for breast cancer)
- •Have completed chemotherapy treatment for at least 4 weeks but not more than 24 weeks and all side effects related to chemotherapy are recovered, improved or maintained, with the exception of hair loss
排除标准
- •Any disease/infection/abnormality of the eye or area around the eye
- •Any ocular surgery within 3 months or anticipated need for ocular surgery during the study
- •Any permanent eyeliner or implants of any kind or anticipated use of false eyelashes
- •Any semi-permanent eyelash tint, dye, curl or eyelash extension application within 3 months
- •Use of any over-the-counter eyelash growth product within 6 months or any use of prescription eyelash growth products
- •Use of treatments which may affect hair growth (eg, minoxidil) within 6 months except for prior chemotherapy
研究组 & 干预措施
bimatoprost solution 0.03%
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
干预措施: bimatoprost solution 0.03% (Drug)
bimatoprost vehicle solution
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
干预措施: bimatoprost vehicle solution (Drug)
结局指标
主要结局
Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)
时间窗: Baseline, Month 4
The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement.
次要结局
- Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)(Baseline, Month 4)
- Change From Baseline in Eyelash Thickness as Measured by DIA(Baseline, Month 4)
- Change From Baseline in Eyelash Darkness as Measured by DIA(Baseline, Month 4)