Trial Outcomes & Findings for Restasis for Treatment of Brittle Nails (NCT NCT00986427)
NCT ID: NCT00986427
Last Updated: 2013-08-20
Results Overview
Change from baseline in the Physician's Global Assessment (PGA) of target fingernails #1 and #2 as measured at week 24. The PGA is a static evaluation/measure of the severity of brittle nails signs in target fingernails #1 and #2 (the 2 nails with the most severe signs of brittleness). Evaluated sings were the degree of lamellar onychoschizia, ridging, longtitudinal splitting, fragility/breakage and thickness. The PGA was scored on a 6 point scale from 0 to 5, in which 0 = none, 1 = mild, 2 = mild to moderate, 3 = moderate, 4 = moderate to severe, 5 = severe. A negative number change from baseline (decrease in grade score) indicates improvement and a positive change (increase in grade score) indicates worsening.
COMPLETED
PHASE2
24 participants
Baseline, week 24
2013-08-20
Participant Flow
24 patients recruited.
Participant milestones
| Measure |
Restasis® Arm
Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
|
Refresh® Arm
Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
8
|
12
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Restasis® Arm
Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
|
Refresh® Arm
Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Restasis for Treatment of Brittle Nails
Baseline characteristics by cohort
| Measure |
Restasis® Arm
n=12 Participants
Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
|
Refresh® Arm
n=12 Participants
Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
59.8 years
STANDARD_DEVIATION 49.40 • n=5 Participants
|
59.6 years
STANDARD_DEVIATION 12.69 • n=7 Participants
|
59.7 years
STANDARD_DEVIATION 13.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 24Change from baseline in the Physician's Global Assessment (PGA) of target fingernails #1 and #2 as measured at week 24. The PGA is a static evaluation/measure of the severity of brittle nails signs in target fingernails #1 and #2 (the 2 nails with the most severe signs of brittleness). Evaluated sings were the degree of lamellar onychoschizia, ridging, longtitudinal splitting, fragility/breakage and thickness. The PGA was scored on a 6 point scale from 0 to 5, in which 0 = none, 1 = mild, 2 = mild to moderate, 3 = moderate, 4 = moderate to severe, 5 = severe. A negative number change from baseline (decrease in grade score) indicates improvement and a positive change (increase in grade score) indicates worsening.
Outcome measures
| Measure |
Restasis® Arm
n=12 Participants
Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
|
Refresh® Arm
n=12 Participants
Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
|
Refresh® Dry Eye Treated Nail
Refresh® Dry Eye Therapy Treated Nail
|
Refresh® Dry Eye Untreated Nail
Refresh® Dry Eye Therapy Untreated Nail
|
|---|---|---|---|---|
|
Change From Baseline in the Physician's Global Assessment (PGA) of Target Fingernails #1 and #2
|
-1.4 scores on a scale
Standard Deviation 0.90
|
-1.4 scores on a scale
Standard Deviation 0.67
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 24Change from baseline in quality of life as measured at week 24 by the subject satisfaction Questionnaire question: "Overall, how satisfied are you with your nails?" Responses ranged from 1 (very satisfied) to 5 (very unsatisfied). A negative number changed from baseline (decrease in grade score) indicates improvement and a positive change (increase in grade score) indicates worsening.
Outcome measures
| Measure |
Restasis® Arm
n=12 Participants
Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
|
Refresh® Arm
n=12 Participants
Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
|
Refresh® Dry Eye Treated Nail
Refresh® Dry Eye Therapy Treated Nail
|
Refresh® Dry Eye Untreated Nail
Refresh® Dry Eye Therapy Untreated Nail
|
|---|---|---|---|---|
|
Change From Baseline in Quality of Life (QOL) Related to Nail Disease
|
-1.6 scores on a scale
Standard Deviation 1.19
|
-0.9 scores on a scale
Standard Deviation 1.97
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24Growth of the treated and untreated nail the previous 4 weeks. Nail growth was measured in millimeters.
Outcome measures
| Measure |
Restasis® Arm
n=12 Participants
Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
|
Refresh® Arm
n=12 Participants
Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
|
Refresh® Dry Eye Treated Nail
n=12 Participants
Refresh® Dry Eye Therapy Treated Nail
|
Refresh® Dry Eye Untreated Nail
n=12 Participants
Refresh® Dry Eye Therapy Untreated Nail
|
|---|---|---|---|---|
|
Growth of the Treated and Untreated Nail in the Previous 4 Weeks
|
3.1 Millimeters (mm)
Standard Deviation 1.36
|
2.9 Millimeters (mm)
Standard Deviation 1.83
|
2.9 Millimeters (mm)
Standard Deviation 1.15
|
2.7 Millimeters (mm)
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: Week 24Number of subjects achieving improvement in the PGIA. The investigator assessed the two target fingernails with a rating of Excellent, Good, Fair, No Improvement or Worse based on the comparison between the nails at the current visit and high-resolution photographs of the nails taken at baseline. An improvement was a score of Excellent/Good/Fair vs. No Improvement/Worse.
Outcome measures
| Measure |
Restasis® Arm
n=12 Participants
Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
|
Refresh® Arm
n=12 Participants
Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
|
Refresh® Dry Eye Treated Nail
Refresh® Dry Eye Therapy Treated Nail
|
Refresh® Dry Eye Untreated Nail
Refresh® Dry Eye Therapy Untreated Nail
|
|---|---|---|---|---|
|
Number of Subjects Achieving Improvement in the Physician's Global Improvement Assessment (PGIA)
|
10 participants
|
9 participants
|
—
|
—
|
Adverse Events
Restasis® Arm
Refresh® Arm
Serious adverse events
| Measure |
Restasis® Arm
n=12 participants at risk
Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
|
Refresh® Arm
n=12 participants at risk
Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
|
|---|---|---|
|
Gastrointestinal disorders
Hematemasis
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
Other adverse events
| Measure |
Restasis® Arm
n=12 participants at risk
Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
|
Refresh® Arm
n=12 participants at risk
Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Eye disorders
Dry eye symptom
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Fatigue
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Flu signs and symptoms
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Gastrointestinal disorders
Hematemasis
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Inflammation of right shoulder (from a fall)
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Pain from car accident
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Pain in both notched nails
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Pain in right thumb nail
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Tooth abscess - pain
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Infections and infestations
Infection in the right gum
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Nail infection - right middle finger (cat bite)
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Infections and infestations
Sinusitis
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Infections and infestations
Stomach virus
|
0.00%
0/12
|
16.7%
2/12 • Number of events 2
|
|
Infections and infestations
Strep throat
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
33.3%
4/12 • Number of events 4
|
50.0%
6/12 • Number of events 6
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Back Spasms
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
Additional Information
Julian Mackay-Wiggan, MD
Columbia University Dept of Dermatology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place