Trial Outcomes & Findings for Cutaneous Prostaglandin Application: Nail Growth, Nail Brittleness, and Eye Pressure (NCT NCT02448043)
NCT ID: NCT02448043
Last Updated: 2019-12-13
Results Overview
Measured by digital calipers (Ironton 6 in. Stainless Steel Digital Fractional Caliper, Northern Tool and Equipment, Burnsville, MN, USA)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
Baseline, 30 days
Results posted on
2019-12-13
Participant Flow
Subjects were recruited voluntarily from private office practices (DP and AS), and a university-based practice (AT).
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
22
|
|
Overall Study
COMPLETED
|
20
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Protocol Violation
|
1
|
2
|
Baseline Characteristics
Number analyzed for each row differs from the Overall analyzed number because the 'All Participants', 'Male', and 'Female' rows identify different populations
Baseline characteristics by cohort
| Measure |
Right Hand Bimatoprost 0.01% Drops, Left Hand Placebo
n=20 Participants
* 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
|
Left Hand Bimatoprost 0.01% Drops, Right Hand Placebo
n=18 Participants
* 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.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
All participants
|
60.30 Years
STANDARD_DEVIATION 9.27 • n=20 Participants • Number analyzed for each row differs from the Overall analyzed number because the 'All Participants', 'Male', and 'Female' rows identify different populations
|
63.33 Years
STANDARD_DEVIATION 15.26 • n=18 Participants • Number analyzed for each row differs from the Overall analyzed number because the 'All Participants', 'Male', and 'Female' rows identify different populations
|
61.61 Years
STANDARD_DEVIATION 12.27 • n=38 Participants • Number analyzed for each row differs from the Overall analyzed number because the 'All Participants', 'Male', and 'Female' rows identify different populations
|
|
Age, Continuous
Male
|
67 Years
STANDARD_DEVIATION 7.07 • n=2 Participants • Number analyzed for each row differs from the Overall analyzed number because the 'All Participants', 'Male', and 'Female' rows identify different populations
|
88 Years
STANDARD_DEVIATION 0 • n=1 Participants • Number analyzed for each row differs from the Overall analyzed number because the 'All Participants', 'Male', and 'Female' rows identify different populations
|
74 Years
STANDARD_DEVIATION 13.11 • n=3 Participants • Number analyzed for each row differs from the Overall analyzed number because the 'All Participants', 'Male', and 'Female' rows identify different populations
|
|
Age, Continuous
Female
|
59.28 Years
STANDARD_DEVIATION 9.19 • n=18 Participants • Number analyzed for each row differs from the Overall analyzed number because the 'All Participants', 'Male', and 'Female' rows identify different populations
|
61.88 Years
STANDARD_DEVIATION 14.39 • n=17 Participants • Number analyzed for each row differs from the Overall analyzed number because the 'All Participants', 'Male', and 'Female' rows identify different populations
|
60.5 Years
STANDARD_DEVIATION 11.79 • n=35 Participants • Number analyzed for each row differs from the Overall analyzed number because the 'All Participants', 'Male', and 'Female' rows identify different populations
|
|
Sex: Female, Male
Female
|
18 Participants
n=20 Participants
|
17 Participants
n=18 Participants
|
35 Participants
n=38 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=20 Participants
|
1 Participants
n=18 Participants
|
3 Participants
n=38 Participants
|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=20 Participants
|
17 Participants
n=18 Participants
|
32 Participants
n=38 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=20 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=38 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=20 Participants
|
1 Participants
n=18 Participants
|
3 Participants
n=38 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=20 Participants
|
0 Participants
n=18 Participants
|
2 Participants
n=38 Participants
|
|
Nail Length of Hands
|
12.5 mm
STANDARD_DEVIATION 1.32 • n=20 Participants
|
12.21 mm
STANDARD_DEVIATION 1.74 • n=18 Participants
|
12.39 mm
STANDARD_DEVIATION 1.51 • n=38 Participants
|
|
Nail Length of Digits
Thumb
|
14.50 mm
STANDARD_DEVIATION 1.68 • n=20 Participants • In the "Left Hand Bimatoprost, Right Hand Placebo" group, 1 subject is missing a forefinger
|
13.85 mm
STANDARD_DEVIATION 2.10 • n=18 Participants • In the "Left Hand Bimatoprost, Right Hand Placebo" group, 1 subject is missing a forefinger
|
14.18 mm
STANDARD_DEVIATION 0.30 • n=38 Participants • In the "Left Hand Bimatoprost, Right Hand Placebo" group, 1 subject is missing a forefinger
|
|
Nail Length of Digits
Forefinger
|
12.26 mm
STANDARD_DEVIATION 1.64 • n=20 Participants • In the "Left Hand Bimatoprost, Right Hand Placebo" group, 1 subject is missing a forefinger
|
12.28 mm
STANDARD_DEVIATION 1.94 • n=17 Participants • In the "Left Hand Bimatoprost, Right Hand Placebo" group, 1 subject is missing a forefinger
|
12.27 mm
STANDARD_DEVIATION 0.21 • n=37 Participants • In the "Left Hand Bimatoprost, Right Hand Placebo" group, 1 subject is missing a forefinger
|
|
Nail Length of Digits
Middle Finger
|
12.81 mm
STANDARD_DEVIATION 1.70 • n=20 Participants • In the "Left Hand Bimatoprost, Right Hand Placebo" group, 1 subject is missing a forefinger
|
12.52 mm
STANDARD_DEVIATION 2.08 • n=18 Participants • In the "Left Hand Bimatoprost, Right Hand Placebo" group, 1 subject is missing a forefinger
|
12.67 mm
STANDARD_DEVIATION 0.27 • n=38 Participants • In the "Left Hand Bimatoprost, Right Hand Placebo" group, 1 subject is missing a forefinger
|
|
Nail Length of Digits
Ring Finger
|
12.50 mm
STANDARD_DEVIATION 1.60 • n=20 Participants • In the "Left Hand Bimatoprost, Right Hand Placebo" group, 1 subject is missing a forefinger
|
12.21 mm
STANDARD_DEVIATION 2.04 • n=18 Participants • In the "Left Hand Bimatoprost, Right Hand Placebo" group, 1 subject is missing a forefinger
|
12.35 mm
STANDARD_DEVIATION 0.31 • n=38 Participants • In the "Left Hand Bimatoprost, Right Hand Placebo" group, 1 subject is missing a forefinger
|
|
Nail Length of Digits
Pinky Finger
|
10.42 mm
STANDARD_DEVIATION 1.43 • n=20 Participants • In the "Left Hand Bimatoprost, Right Hand Placebo" group, 1 subject is missing a forefinger
|
10.26 mm
STANDARD_DEVIATION 1.66 • n=18 Participants • In the "Left Hand Bimatoprost, Right Hand Placebo" group, 1 subject is missing a forefinger
|
10.34 mm
STANDARD_DEVIATION 0.16 • n=38 Participants • In the "Left Hand Bimatoprost, Right Hand Placebo" group, 1 subject is missing a forefinger
|
|
Intraocular Pressure
Both eyes
|
16.23 mm Hg
STANDARD_DEVIATION 3.85 • n=13 Participants • No baseline IOP data on 13 subjects
|
13.67 mm Hg
STANDARD_DEVIATION 2.91 • n=12 Participants • No baseline IOP data on 13 subjects
|
15 mm Hg
STANDARD_DEVIATION 3.64 • n=25 Participants • No baseline IOP data on 13 subjects
|
|
Intraocular Pressure
Right eye
|
16.00 mm Hg
STANDARD_DEVIATION 2.89 • n=13 Participants • No baseline IOP data on 13 subjects
|
13.83 mm Hg
STANDARD_DEVIATION 3.24 • n=12 Participants • No baseline IOP data on 13 subjects
|
14.96 mm Hg
STANDARD_DEVIATION 3.19 • n=25 Participants • No baseline IOP data on 13 subjects
|
|
Intraocular Pressure
Left eye
|
16.46 mm Hg
STANDARD_DEVIATION 4.74 • n=13 Participants • No baseline IOP data on 13 subjects
|
13.5 mm Hg
STANDARD_DEVIATION 2.68 • n=12 Participants • No baseline IOP data on 13 subjects
|
15.04 mm Hg
STANDARD_DEVIATION 4.10 • n=25 Participants • No baseline IOP data on 13 subjects
|
|
Nail Brittleness
|
2.61 Score on a scale
STANDARD_DEVIATION 0.98 • n=18 Participants • No or incomplete data 2 participants
|
2.42 Score on a scale
STANDARD_DEVIATION 1.06 • n=18 Participants • No or incomplete data 2 participants
|
2.51 Score on a scale
STANDARD_DEVIATION 1.01 • n=36 Participants • No or incomplete data 2 participants
|
PRIMARY outcome
Timeframe: Baseline, 30 daysPopulation: Intent to treat population
Measured by digital calipers (Ironton 6 in. Stainless Steel Digital Fractional Caliper, Northern Tool and Equipment, Burnsville, MN, USA)
Outcome measures
| Measure |
Bimatoprost 0.01% Drops
n=38 Hands
Bimatoprost 0.01%: Bimatoprost drops added to the proximal nail folds of the randomized study hand digits two times per day for 30 days
|
Placebo
n=38 Hands
Saline solution drops placed on the proximal nail folds of the hand digits opposite from the study hand two times per day for 30 days.
|
|---|---|---|
|
Change From Baseline in Nail Length of Hands
Total Nail Growth (power = 1.0)
|
13.49 mm
Standard Deviation 1.14
|
15.10 mm
Standard Deviation 1.29
|
|
Change From Baseline in Nail Length of Hands
Individual Nail Growth
|
1.34 mm
Standard Deviation 0.33
|
1.51 mm
Standard Deviation 0.48
|
PRIMARY outcome
Timeframe: Baseline, 30 DaysPopulation: Excluding the negative growth nails and chipped nails combined; one subject is missing a forefinger
Measured by digital calipers (Ironton 6 in. Stainless Steel Digital Fractional Caliper, Northern Tool and Equipment, Burnsville, MN, USA)
Outcome measures
| Measure |
Bimatoprost 0.01% Drops
n=189 Digits
Bimatoprost 0.01%: Bimatoprost drops added to the proximal nail folds of the randomized study hand digits two times per day for 30 days
|
Placebo
n=190 Digits
Saline solution drops placed on the proximal nail folds of the hand digits opposite from the study hand two times per day for 30 days.
|
|---|---|---|
|
Change From Baseline in Nail Length of Digits
Thumb
|
1.58 mm
Standard Deviation 1.70
|
1.48 mm
Standard Deviation 1.82
|
|
Change From Baseline in Nail Length of Digits
Forefinger
|
1.26 mm
Standard Deviation 1.38
|
1.02 mm
Standard Deviation 2.76
|
|
Change From Baseline in Nail Length of Digits
Middle Finger
|
0.90 mm
Standard Deviation 1.76
|
1.40 mm
Standard Deviation 1.50
|
|
Change From Baseline in Nail Length of Digits
Ring Finger
|
1.33 mm
Standard Deviation 1.27
|
1.76 mm
Standard Deviation 1.77
|
|
Change From Baseline in Nail Length of Digits
Pinky Finger
|
1.63 mm
Standard Deviation 1.55
|
1.62 mm
Standard Deviation 1.65
|
PRIMARY outcome
Timeframe: Between 7:30 AM and 10:00 AM at 30 days post treatmentPopulation: 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.
IOP using a Goldmann applanation tonometer (GAT) between 7:30 AM and 10:00 AM
Outcome measures
| Measure |
Bimatoprost 0.01% Drops
n=26 Eyes
Bimatoprost 0.01%: Bimatoprost drops added to the proximal nail folds of the randomized study hand digits two times per day for 30 days
|
Placebo
n=22 Eyes
Saline solution drops placed on the proximal nail folds of the hand digits opposite from the study hand two times per day for 30 days.
|
|---|---|---|
|
Intraocular Pressure at 30 Days of Treatment
Both eyes
|
16.42 mm Hg
Standard Deviation 3.24
|
13.91 mm Hg
Standard Deviation 1.80
|
|
Intraocular Pressure at 30 Days of Treatment
Right eye
|
16.38 mm Hg
Standard Deviation 3.73
|
14.0 mm Hg
Standard Deviation 2.10
|
|
Intraocular Pressure at 30 Days of Treatment
Left eye
|
16.46 mm Hg
Standard Deviation 2.82
|
13.82 mm Hg
Standard Deviation 1.54
|
PRIMARY outcome
Timeframe: Baseline, 30 daysPopulation: 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.
Scale Title: Nail Brittleness (1-4) Subjective assessment by subjects on scale of 1 (no brittleness) to 4 (maximum brittleness).
Outcome measures
| Measure |
Bimatoprost 0.01% Drops
n=16 Participants
Bimatoprost 0.01%: Bimatoprost drops added to the proximal nail folds of the randomized study hand digits two times per day for 30 days
|
Placebo
n=15 Participants
Saline solution drops placed on the proximal nail folds of the hand digits opposite from the study hand two times per day for 30 days.
|
|---|---|---|
|
Nail Brittleness at 30 Days of Treatment
|
2.25 Score on a scale
Standard Deviation 0.93
|
2.43 Score on a scale
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: Baseline to 30 daysPopulation: \- No nail chipping data on 12 participants
Average number of days post-treatment until the first nail chipped
Outcome measures
| Measure |
Bimatoprost 0.01% Drops
n=26 Hands
Bimatoprost 0.01%: Bimatoprost drops added to the proximal nail folds of the randomized study hand digits two times per day for 30 days
|
Placebo
n=26 Hands
Saline solution drops placed on the proximal nail folds of the hand digits opposite from the study hand two times per day for 30 days.
|
|---|---|---|
|
Number of Days Until the First Nail Chipped
|
8.38 Days
Standard Deviation 9.36
|
6.26 Days
Standard Deviation 8.12
|
SECONDARY outcome
Timeframe: Baseline, 30 daysPopulation: * Data omitted for 4 subjects with pigmented control and medication hands * No data for an additional 4 subjects due to poor photo quality
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.
Outcome measures
| Measure |
Bimatoprost 0.01% Drops
n=30 Hands
Bimatoprost 0.01%: Bimatoprost drops added to the proximal nail folds of the randomized study hand digits two times per day for 30 days
|
Placebo
n=30 Hands
Saline solution drops placed on the proximal nail folds of the hand digits opposite from the study hand two times per day for 30 days.
|
|---|---|---|
|
Change in Skin Pigmentation on Hands
Decreased Pigmentation
|
10 Hands
|
0 Hands
|
|
Change in Skin Pigmentation on Hands
No Change in Pigmentation
|
19 Hands
|
30 Hands
|
|
Change in Skin Pigmentation on Hands
Increased Pigmentation
|
1 Hands
|
0 Hands
|
SECONDARY outcome
Timeframe: Baseline, 30 daysPopulation: \- No data on 4 participants due to poor photo quality
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.
Outcome measures
| Measure |
Bimatoprost 0.01% Drops
n=34 Hands
Bimatoprost 0.01%: Bimatoprost drops added to the proximal nail folds of the randomized study hand digits two times per day for 30 days
|
Placebo
n=34 Hands
Saline solution drops placed on the proximal nail folds of the hand digits opposite from the study hand two times per day for 30 days.
|
|---|---|---|
|
Change in Hirsutism on Hands
Decreased Hair Growth
|
0 Hands
|
0 Hands
|
|
Change in Hirsutism on Hands
No Change in Hair Growth
|
34 Hands
|
34 Hands
|
|
Change in Hirsutism on Hands
Increased Hair Growth
|
0 Hands
|
0 Hands
|
Adverse Events
Bimatoprost 0.01% Drops
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. David J. Palmer
Department of Ophthalmology, Northwestern University Feinberg School of Medicine
Phone: 3126958150
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place