Cutaneous Prostaglandin Application: Nail Growth, Nail Brittleness, and Eye Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change From Baseline in Nail Length of Hands
研究概览
简要总结
Topical prostaglandin agents are used to help reduce eye pressure in glaucoma patients. Bimatoprost (Lumigan 0.01%) is such an agent (Allergan, Inc.). Several of our patients on bimatoprost and an observational study of patients on bimatoprost in another center reported that fingernails grew longer and became less brittle using the topical eye drops to the eyes. The purpose of the double-blinded study is to determine whether the application of the eye drops directly to the proximal nail fold of one hand using the opposite hand as a control will result in longer nails, less brittle nails, and reduced eye pressures should any of the medication be absorbed into the systemic circulation.
详细描述
In addition to our observations with topical bimatoprost on fingernail growth, Wand and colleagues applied bimatoprost to the base of the fingernails demonstrating a 16.9% increase in fingernail growth from baseline, and a 10.4% increase from baseline on untreated nail beds. Other than these two reports, there are no studies addressing this topic to our knowledge based on a Medline search for off-label use of this drug. Other relevant studies have addressed increased hair and eyelash growth with the prostaglandin agents. Researching the biochemistry of the relationship of prostaglandins to hair and nail growth, the final common pathway appears to be with protein kinase C and the production of tropocollagens. The dermatology literature has demonstrated that both hair and nail keratocytes reside in the nail bed suggesting that increased collagen production may enhance the growth of both the nail bed and nail plate, possibly reducing nail brittleness.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English speaking
- •Normotensive or glaucoma suspects on no ocular medications
- •No manicure within 2 weeks of the study.
排除标准
- •Individuals on topical or systemic essential fatty acids (EFA's) in hand lotions, creams, ointments, or medication, or on biotin.
- •Digits with signs of nail injury, deformity, or infection.
- •Nail biters, nail polishers, artificial nail wear or gels, and nail and trimming and filing until the study endpoint.
- •Women of childbearing age who are pregnant or who are trying to become pregnant.
- •Individuals with allergies or sensitivity to prostaglandin agents.
研究组 & 干预措施
Right Hand Bimatoprost 0.01% drops, Left Hand Placebo
- Bimatoprost 0.01% drops placed on the proximal nail folds of the right hand digits two times per day for 30 days.
- Saline solution drops placed on the proximal nail folds of the left hand digits two times per day for 30 days.
干预措施: Bimatoprost 0.01% (Drug)
Left Hand Bimatoprost 0.01% drops, Right Hand Placebo
- Bimatoprost 0.01% drops placed on the proximal nail folds of the left hand digits two times per day for 30 days.
- Saline solution drops placed on the proximal nail folds of the right hand digits two times per day for 30 days.
干预措施: Bimatoprost 0.01% (Drug)
结局指标
主要结局
Change From Baseline in Nail Length of Hands
时间窗: Baseline, 30 days
Measured by digital calipers (Ironton 6 in. Stainless Steel Digital Fractional Caliper, Northern Tool and Equipment, Burnsville, MN, USA)
Change From Baseline in Nail Length of Digits
时间窗: Baseline, 30 Days
Measured by digital calipers (Ironton 6 in. Stainless Steel Digital Fractional Caliper, Northern Tool and Equipment, Burnsville, MN, USA)
Intraocular Pressure at 30 Days of Treatment
时间窗: Between 7:30 AM and 10:00 AM at 30 days post treatment
IOP using a Goldmann applanation tonometer (GAT) between 7:30 AM and 10:00 AM
Nail Brittleness at 30 Days of Treatment
时间窗: Baseline, 30 days
Scale Title: Nail Brittleness (1-4) Subjective assessment by subjects on scale of 1 (no brittleness) to 4 (maximum brittleness).
次要结局
- Number of Days Until the First Nail Chipped(Baseline to 30 days)
- Change in Skin Pigmentation on Hands(Baseline, 30 days)
- Change in Hirsutism on Hands(Baseline, 30 days)
研究者
David Palmer
Assistant Professor of Clinical Ophthalmology
Northwestern University