Cutaneous Prostaglandin Application: Nail Growth, Nail Brittleness, and Eye Pressure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cutaneous Prostaglandin Application: Nail Growth, Nail Brittleness, and Eye Pressure

Conditions
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Nail Growth Cessation, Intraocular Pressure

Intervention / Treatment
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* Drug: Bimatoprost 0.01%
* Other: Placebo: saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English speaking Normotensive or glaucoma suspects on no ocular medications No manicure within 2 weeks of the study. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Right Hand Bimatoprost 0.01% drops, Left Hand Placebo<br>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. | Drug: Bimatoprost 0.01%<br>* Bimatoprost drops added to the proximal nail folds of the randomized study hand digits two times per day for 30 days<br>* Other names: Lumigan 0.01%;Other: Placebo: saline<br>* Placebo drops added to the proximal nail folds of the hand digits opposite the study hand two times per day for 30 days<br>|
| Other: Left Hand Bimatoprost 0.01% drops, Right Hand Placebo<br>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. | Drug: Bimatoprost 0.01%<br>* Bimatoprost drops added to the proximal nail folds of the randomized study hand digits two times per day for 30 days<br>* Other names: Lumigan 0.01%;Other: Placebo: saline<br>* Placebo drops added to the proximal nail folds of the hand digits opposite the study hand two times per day for 30 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Nail Length of Hands | Measured by digital calipers (Ironton 6 in. Stainless Steel Digital Fractional Caliper, Northern Tool and Equipment, Burnsville, MN, USA) | Baseline, 30 days | 
| Change From Baseline in Nail Length of Digits | Measured by digital calipers (Ironton 6 in. Stainless Steel Digital Fractional Caliper, Northern Tool and Equipment, Burnsville, MN, USA) | Baseline, 30 Days | 
| Intraocular Pressure at 30 Days of Treatment | IOP using a Goldmann applanation tonometer (GAT) between 7:30 AM and 10:00 AM | Between 7:30 AM and 10:00 AM at 30 days post treatment | 
| Nail Brittleness at 30 Days of Treatment | Scale Title: Nail Brittleness (1-4) Subjective assessment by subjects on scale of 1 (no brittleness) to 4 (maximum brittleness). | Baseline, 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Days Until the First Nail Chipped | Average number of days post-treatment until the first nail chipped | Baseline to 30 days | 
| Change in Skin Pigmentation on Hands | Photographs taken (knuckle to fingertips over white paper with consistent bulb illumination at the site), with an Apple iPhone 6 (Cupertino, CA, USA) and examined. The investigators reviewed the anonymous photos by number to look for comparative skin pigmentation (increased pigmentation, decreased pigmentation, no change in pigmentation) changes on the hands. | Baseline, 30 days | 
| Change in Hirsutism on Hands | Photographs taken (knuckle to fingertips over white paper with consistent bulb illumination at the site), with an Apple iPhone 6 (Cupertino, CA, USA) and examined. The investigators reviewed the anonymous photos by number to look for comparative (increased hair growth, decreased hair growth, no change) hair changes on the hands. | Baseline, 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brittleness