Topical Bimatoprost Effect on Androgen Dependent Hair Follicles
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 主要终点
- Percent Change in Target Area Total Hair Count
研究概览
简要总结
The purpose of this study is to determine the effect of bimatoprost solution on scalp hair growth. Bimatoprost 0.03% ophthalmic solution is currently approved by the FDA for treatment of glaucoma (Lumigan™) and for thickening of thin eyelashes (Latisse™). Bimatoprost 0.03% is not approved for the treatment of scalp hair loss and its use in this study is considered investigational which means it is still being tested in research studies.
Thirty-three subjects were consented and screened, 9 entered and 9 completed the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Hamilton-Norwood patterns of baldness IIIV, IV, V, or VA.
- •Subject's hair color must have adequate contrast against scalp color to allow hair counting on macrophotography.
- •Good health with normal blood tests for hematological, renal, and liver function.
- •Able to return to Duke for study visits.
排除标准
- •Used topical or oral minoxidil in the past 6 months, oral finasteride in the past 12 months or oral dutasteride in the past 24 months.
- •Taken any warfarin, heparin, or retinoid for greater than 2 weeks during the past 6 months and any in the past month.
- •Taken any chemotherapy in the past 2 years.
- •Used any over-the-counter (OTC) preparation that purports to help hair growth in the past four months.
- •Used prostaglandins of any type in the past or currently.
- •Any history of alopecia areata, cicatricial alopecia, radiation to the head, hair transplants, or scalp reductions.
- •Any skin abnormalities in the target area that would effect hair growth.
- •Any history of glaucoma or elevated intraocular pressure (IOP).
- •Any cancer other than non-melanoma skin cancer (NMSC) in the past 2 years and all must be in remission.
研究组 & 干预措施
Active drug
During Part I of the study, subjects will be randomized in a blinded fashion to either placebo (vehicle that does not contain active drug) or topical bimatoprost to apply to the scalp target area every day for 16 weeks. After a 10 day washout period, each group will be crossed over to the alternate topical preparation (Part II) to apply for 16 weeks.
干预措施: Bimatoprost (Drug)
Active drug
During Part I of the study, subjects will be randomized in a blinded fashion to either placebo (vehicle that does not contain active drug) or topical bimatoprost to apply to the scalp target area every day for 16 weeks. After a 10 day washout period, each group will be crossed over to the alternate topical preparation (Part II) to apply for 16 weeks.
干预措施: Placebo (Drug)
Placebo
During Part I of the study, subjects will be randomized in a blinded fashion to either placebo (vehicle that does not contain active drug) or topical bimatoprost to apply to the scalp target area every day for 16 weeks. After a 10 day washout period, each group will be crossed over to the alternate topical preparation (Part II) to apply for 16 weeks.
干预措施: Bimatoprost (Drug)
Placebo
During Part I of the study, subjects will be randomized in a blinded fashion to either placebo (vehicle that does not contain active drug) or topical bimatoprost to apply to the scalp target area every day for 16 weeks. After a 10 day washout period, each group will be crossed over to the alternate topical preparation (Part II) to apply for 16 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change in Target Area Total Hair Count
时间窗: Baseline to week 17; and week 17 to week 34
The primary endpoint is the percent change in total hair count from the beginning and end of each part of the study.
次要结局
- Percent Change in the Target Area Vellus Hair Count(Baseline to week 17; and week 17 to week 34)
- Percent Change in Hair Diameter(Baseline to week 17; Week 17 to week 34)
- Percent Change in the Target Area Terminal Hair Count(Baseline to week 17; and week 17 to week 34)