Nail Growth Cessation, Intraocular Pressure
Conditions
Keywords
brittleness
Brief summary
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
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.
Interventions
Bimatoprost drops added to the proximal nail folds of the randomized study hand digits two times per day for 30 days
OTHERPlacebo: saline
Placebo drops added to the proximal nail folds of the hand digits opposite the study hand two times per day for 30 days
Sponsors
Allergan
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Nail Length of Hands | 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 | 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 | 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 | Baseline, 30 days | Scale Title: Nail Brittleness (1-4) Subjective assessment by subjects on scale of 1 (no brittleness) to 4 (maximum brittleness). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Skin Pigmentation on Hands | Baseline, 30 days | 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. |
| Change in Hirsutism on Hands | Baseline, 30 days | 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. |
| Number of Days Until the First Nail Chipped | Baseline to 30 days | Average number of days post-treatment until the first nail chipped |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited voluntarily from private office practices (DP and AS), and a university-based practice (AT).
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| 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. | 18 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Right Hand Bimatoprost 0.01% Drops, Left Hand Placebo | Left Hand Bimatoprost 0.01% Drops, Right Hand Placebo | Total |
|---|---|---|---|
| Age, Continuous All participants | 60.30 Years STANDARD_DEVIATION 9.27 | 63.33 Years STANDARD_DEVIATION 15.26 | 61.61 Years STANDARD_DEVIATION 12.27 |
| Age, Continuous Female | 59.28 Years STANDARD_DEVIATION 9.19 | 61.88 Years STANDARD_DEVIATION 14.39 | 60.5 Years STANDARD_DEVIATION 11.79 |
| Age, Continuous Male | 67 Years STANDARD_DEVIATION 7.07 | 88 Years STANDARD_DEVIATION 0 | 74 Years STANDARD_DEVIATION 13.11 |
| Intraocular Pressure Both eyes | 16.23 mm Hg STANDARD_DEVIATION 3.85 | 13.67 mm Hg STANDARD_DEVIATION 2.91 | 15 mm Hg STANDARD_DEVIATION 3.64 |
| Intraocular Pressure Left eye | 16.46 mm Hg STANDARD_DEVIATION 4.74 | 13.5 mm Hg STANDARD_DEVIATION 2.68 | 15.04 mm Hg STANDARD_DEVIATION 4.1 |
| Intraocular Pressure Right eye | 16.00 mm Hg STANDARD_DEVIATION 2.89 | 13.83 mm Hg STANDARD_DEVIATION 3.24 | 14.96 mm Hg STANDARD_DEVIATION 3.19 |
| Nail Brittleness | 2.61 Score on a scale STANDARD_DEVIATION 0.98 | 2.42 Score on a scale STANDARD_DEVIATION 1.06 | 2.51 Score on a scale STANDARD_DEVIATION 1.01 |
| Nail Length of Digits Forefinger | 12.26 mm STANDARD_DEVIATION 1.64 | 12.28 mm STANDARD_DEVIATION 1.94 | 12.27 mm STANDARD_DEVIATION 0.21 |
| Nail Length of Digits Middle Finger | 12.81 mm STANDARD_DEVIATION 1.7 | 12.52 mm STANDARD_DEVIATION 2.08 | 12.67 mm STANDARD_DEVIATION 0.27 |
| Nail Length of Digits Pinky Finger | 10.42 mm STANDARD_DEVIATION 1.43 | 10.26 mm STANDARD_DEVIATION 1.66 | 10.34 mm STANDARD_DEVIATION 0.16 |
| Nail Length of Digits Ring Finger | 12.50 mm STANDARD_DEVIATION 1.6 | 12.21 mm STANDARD_DEVIATION 2.04 | 12.35 mm STANDARD_DEVIATION 0.31 |
| Nail Length of Digits Thumb | 14.50 mm STANDARD_DEVIATION 1.68 | 13.85 mm STANDARD_DEVIATION 2.1 | 14.18 mm STANDARD_DEVIATION 0.3 |
| Nail Length of Hands | 12.5 mm STANDARD_DEVIATION 1.32 | 12.21 mm STANDARD_DEVIATION 1.74 | 12.39 mm STANDARD_DEVIATION 1.51 |
| Race/Ethnicity, Customized Asian | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Black | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 15 Participants | 17 Participants | 32 Participants |
| Sex: Female, Male Female | 18 Participants | 17 Participants | 35 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 38 | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 | 0 / 38 |
Outcome results
Primary
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)
Time frame: Baseline, 30 Days
Population: Excluding the negative growth nails and chipped nails combined; one subject is missing a forefinger
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost 0.01% Drops | Change From Baseline in Nail Length of Digits | Middle Finger | 0.90 mm | Standard Deviation 1.76 |
| Bimatoprost 0.01% Drops | Change From Baseline in Nail Length of Digits | Ring Finger | 1.33 mm | Standard Deviation 1.27 |
| Bimatoprost 0.01% Drops | Change From Baseline in Nail Length of Digits | Forefinger | 1.26 mm | Standard Deviation 1.38 |
| Bimatoprost 0.01% Drops | Change From Baseline in Nail Length of Digits | Pinky Finger | 1.63 mm | Standard Deviation 1.55 |
| Bimatoprost 0.01% Drops | Change From Baseline in Nail Length of Digits | Thumb | 1.58 mm | Standard Deviation 1.7 |
| Placebo | Change From Baseline in Nail Length of Digits | Pinky Finger | 1.62 mm | Standard Deviation 1.65 |
| Placebo | Change From Baseline in Nail Length of Digits | Thumb | 1.48 mm | Standard Deviation 1.82 |
| Placebo | Change From Baseline in Nail Length of Digits | Forefinger | 1.02 mm | Standard Deviation 2.76 |
| Placebo | Change From Baseline in Nail Length of Digits | Ring Finger | 1.76 mm | Standard Deviation 1.77 |
| Placebo | Change From Baseline in Nail Length of Digits | Middle Finger | 1.40 mm | Standard Deviation 1.5 |
p-value: 0.523t-test, 2 sided
Primary
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)
Time frame: Baseline, 30 days
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost 0.01% Drops | Change From Baseline in Nail Length of Hands | Total Nail Growth (power = 1.0) | 13.49 mm | Standard Deviation 1.14 |
| Bimatoprost 0.01% Drops | Change From Baseline in Nail Length of Hands | Individual Nail Growth | 1.34 mm | Standard Deviation 0.33 |
| Placebo | Change From Baseline in Nail Length of Hands | Total Nail Growth (power = 1.0) | 15.10 mm | Standard Deviation 1.29 |
| Placebo | Change From Baseline in Nail Length of Hands | Individual Nail Growth | 1.51 mm | Standard Deviation 0.48 |
p-value: 0.532t-test, 2 sided
Primary
Intraocular Pressure at 30 Days of Treatment
IOP using a Goldmann applanation tonometer (GAT) between 7:30 AM and 10:00 AM
Time frame: Between 7:30 AM and 10:00 AM at 30 days post treatment
Population: No IOP data on 13 subjects Missing final IOP data on 1 subject~Arms are not grouped as 'Bimatoprost 0.01%' and 'Placebo' because this is a split-person study, so every participant received both the treatment and the placebo. Since this outcome is measuring eye pressure, there is no way to distinguish which group/arm is influencing eye pressure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost 0.01% Drops | Intraocular Pressure at 30 Days of Treatment | Both eyes | 16.42 mm Hg | Standard Deviation 3.24 |
| Bimatoprost 0.01% Drops | Intraocular Pressure at 30 Days of Treatment | Right eye | 16.38 mm Hg | Standard Deviation 3.73 |
| Bimatoprost 0.01% Drops | Intraocular Pressure at 30 Days of Treatment | Left eye | 16.46 mm Hg | Standard Deviation 2.82 |
| Placebo | Intraocular Pressure at 30 Days of Treatment | Both eyes | 13.91 mm Hg | Standard Deviation 1.8 |
| Placebo | Intraocular Pressure at 30 Days of Treatment | Right eye | 14.0 mm Hg | Standard Deviation 2.1 |
| Placebo | Intraocular Pressure at 30 Days of Treatment | Left eye | 13.82 mm Hg | Standard Deviation 1.54 |
Comparison: Comparing baseline values of both arms to completion values of both armsp-value: 0.912t-test, 2 sided
Primary
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).
Time frame: Baseline, 30 days
Population: No or incomplete data on seven subjects~Subjects were asked to assess nail brittleness of both hands and rank them together - i.e. the value each subject gave for nail brittleness was the combination of the placebo hand and the treatment hand. Nail brittleness values were not distinguished between the placebo hands and the treatment hands.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bimatoprost 0.01% Drops | Nail Brittleness at 30 Days of Treatment | 2.25 Score on a scale | Standard Deviation 0.93 |
| Placebo | Nail Brittleness at 30 Days of Treatment | 2.43 Score on a scale | Standard Deviation 1.1 |
Comparison: Comparison between baseline nail brittleness values and completion valuesp-value: 0.062t-test, 2 sided
Secondary
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.
Time frame: Baseline, 30 days
Population: \- No data on 4 participants due to poor photo quality
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Bimatoprost 0.01% Drops | Change in Hirsutism on Hands | No Change in Hair Growth | 34 Hands |
| Bimatoprost 0.01% Drops | Change in Hirsutism on Hands | Decreased Hair Growth | 0 Hands |
| Bimatoprost 0.01% Drops | Change in Hirsutism on Hands | Increased Hair Growth | 0 Hands |
| Placebo | Change in Hirsutism on Hands | Decreased Hair Growth | 0 Hands |
| Placebo | Change in Hirsutism on Hands | No Change in Hair Growth | 34 Hands |
| Placebo | Change in Hirsutism on Hands | Increased Hair Growth | 0 Hands |
Secondary
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.
Time frame: Baseline, 30 days
Population: * Data omitted for 4 subjects with pigmented control and medication hands~* No data for an additional 4 subjects due to poor photo quality
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Bimatoprost 0.01% Drops | Change in Skin Pigmentation on Hands | No Change in Pigmentation | 19 Hands |
| Bimatoprost 0.01% Drops | Change in Skin Pigmentation on Hands | Increased Pigmentation | 1 Hands |
| Bimatoprost 0.01% Drops | Change in Skin Pigmentation on Hands | Decreased Pigmentation | 10 Hands |
| Placebo | Change in Skin Pigmentation on Hands | No Change in Pigmentation | 30 Hands |
| Placebo | Change in Skin Pigmentation on Hands | Increased Pigmentation | 0 Hands |
| Placebo | Change in Skin Pigmentation on Hands | Decreased Pigmentation | 0 Hands |
Secondary
Number of Days Until the First Nail Chipped
Average number of days post-treatment until the first nail chipped
Time frame: Baseline to 30 days
Population: \- No nail chipping data on 12 participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bimatoprost 0.01% Drops | Number of Days Until the First Nail Chipped | 8.38 Days | Standard Deviation 9.36 |
| Placebo | Number of Days Until the First Nail Chipped | 6.26 Days | Standard Deviation 8.12 |