Latisse(Bimatoprost .03% Opthalmic Solution) for the Treatment of Hypotrichosis of the Eyebrows: Latisse Versus Placebo
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Efficacy of Latisse applied to the lateral and medial eyebrow
研究概览
简要总结
The primary purpose of this study is to assess efficacy and safety of Latisse (bimatoprost .03% ophthalmic solution) applied to the lateral and medial eyebrows. The primary outcome is a increase in overall eyebrow prominence as measured by at least a 1-grade increase on the Global Eyebrow Assessment (GEyA) scale, from baseline to the end of the treatment which will be day 270 period.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Outpatient, female/male subjects of any race, 18-75 years of age.
- •Subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study
- •Patients with hypotrichosis (thinning) of the eyebrows with a GEyA score of 1 or
- •Patient agrees to abstain from any treatment to the eyebrows including: waxing, plucking, threading, laser hair removal, and/or bleaching (excluding the glabella region).
- •Able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization forms.
- •Written informed consent and written authorization for use or release of health and research information obtained.
- •Willing to complete all required study visits, procedures, and evaluations including photography.
排除标准
- •Subjects who are pregnant (positive urine pregnancy test), planning to become pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
- •Patients with any uncontrolled systemic disease
- •Patient with any known disease or abnormality of the eyebrows including eczema and seborrheic dermatitis
- •Patients with known or suspected trichotillomania disorder
- •Patients with a history of glaucoma and/or increased ocular pressure
- •Patients who are currently using an IOP-lowering prostaglandin analog (including Lumigan)
- •Patients with a known hypersensitivity to bimatoprost or any other ingredient in Latisse
- •Previous cosmetic surgery to the upper face (e.g., periorbital surgery, brow lift, eyelid or eyebrow surgery, etc.).
- •Patients with permanent eye and/or eyebrow make-up
- •Any eyebrow tint or dye applications within 2 months prior to study entry
- •Any planned facial cosmetic procedure that would interfere with the evaluation of the eyebrows
- •Participation in another investigational drug or device study within the last 30 days
研究组 & 干预措施
Topical bimatoprost for eyebrows
Topical bimatoprost will be applied to areas of the eyebrow that have diminished eyebrows (hypotrichosis).
干预措施: topical bimatoprost (Drug)
结局指标
主要结局
Efficacy of Latisse applied to the lateral and medial eyebrow
时间窗: 10 months
Increase in overall eyebrow prominence as measured by at least a 1-grade increase on the Global Eyebrow Assessment (GEyA) scale, from baseline to the end of the treatment which will be day 270 period.
次要结局
未报告次要终点
研究者
Kenneth Beer
Investigator
Beer, Kenneth R., M.D., PA