Safety and Efficacy of Bimatoprost Solution in Treating Eyelash Loss or Hypotrichosis in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 71
- 主要终点
- Percentage of Participants With Adverse Events
研究概览
简要总结
This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily application to the upper eyelid margins compared with vehicle in treating eyelash loss or hypotrichosis (inadequate or not enough eyelashes) in children.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children who have inadequate eyelashes or have lost their eyelashes as a result of chemotherapy treatment, who completed their chemotherapy (intensive treatment) at least 4 weeks before starting the study, are considered to be at low risk for relapse of their cancer, and are well enough to complete the study
- •Children who have minimal to moderate inadequate eyelashes due to alopecia areata
- •Adolescents between the ages of 15-17 years who have minimal to marked inadequate eyelashes
排除标准
- •Any eye disease or abnormality, eye surgery, permanent eyeliner, eyelash implants.
- •Semi-permanent eyelash tint, dye or eyelash extension application within 3 months
- •Use of over the counter eyelash growth products within 6 months.
- •Use of prescription eyelash growth products (eg, Latisse®)
- •Any eye condition that would prevent required ophthalmology exams
研究组 & 干预措施
bimatoprost ophthalmic solution 0.03%
One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
干预措施: bimatoprost ophthalmic solution 0.03% (Drug)
Vehicle Sterile Solution
One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
干预措施: Vehicle Sterile Solution (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events
时间窗: 5 Months
An adverse event was any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Global Eyebrow Assessment (GEA) Score
时间窗: Baseline, Month 4
The physician evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement.
次要结局
- Change From Baseline Upper Eyelash Length as Measured by Digital Image Analysis (DIA)(Baseline, Month 4)
- Change From Baseline in Upper Eyelash Thickness as Measured by DIA(Baseline, Month 4)
- Change From Baseline in Upper Eyelash Darkness as Measured by DIA(Baseline, Month 4)