Trial Outcomes & Findings for Topical Cyclosporine Suspension for the Treatment of Brittle Nails (NCT NCT01064830)
NCT ID: NCT01064830
Last Updated: 2017-03-13
Results Overview
IN a scale of 0-3 where 0 means normal nail and 3 means severe disease, the number of patients who received at least a decrease of 1 grade in the evaluation of two target nails
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
20 weeks
Results posted on
2017-03-13
Participant Flow
Participant milestones
| Measure |
Cyclosporine Solution 0.05% (Restasis®)
Topical Cyclosporine 0.05% Ophthalmic Suspension
|
Vehicle (Refresh Dry Eye Therapy®)
Topical vehicle: Refresh Dry Eye Therapy® (ophthalmic solution of glycerin 1% and polysorbate 80 1%)
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topical Cyclosporine Suspension for the Treatment of Brittle Nails
Baseline characteristics by cohort
| Measure |
Cyclosporine Solution
n=10 Participants
apply to affected nails at night
|
Vehicle
n=11 Participants
apply to affected nails at night
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Age, Continuous
|
48.0 years
STANDARD_DEVIATION 17.76 • n=39 Participants
|
54.8 years
STANDARD_DEVIATION 10.02 • n=41 Participants
|
51.6 years
STANDARD_DEVIATION 14.3 • n=35 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
19 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=39 Participants
|
11 participants
n=41 Participants
|
21 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 20 weeksIN a scale of 0-3 where 0 means normal nail and 3 means severe disease, the number of patients who received at least a decrease of 1 grade in the evaluation of two target nails
Outcome measures
| Measure |
Cyclosporine Solution
n=10 Participants
topical
|
Vehicle
n=11 Participants
topical
|
|---|---|---|
|
• Number of Patients Receiving at Least a 1-grade Improvement in the Physicians Global Improvement Assessment (PGIA) of Two Target Nails.
|
10 patients
|
11 patients
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: all patients enrolled who completed this response measure at week 20.
the percentages of participants who were satisfied with the "length of fingernails"
Outcome measures
| Measure |
Cyclosporine Solution
n=9 Participants
topical
|
Vehicle
n=8 Participants
topical
|
|---|---|---|
|
Patients Assessment of Satisfaction With Length of Fingernails
|
44.4 percentage of patients
|
12.5 percentage of patients
|
Adverse Events
Cyclosporine Solution
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cyclosporine Solution
n=10 participants at risk
topical
|
Vehicle
n=11 participants at risk
topical
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory tract infection
|
20.0%
2/10 • Number of events 2
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
back pain
|
10.0%
1/10 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
sinus infection
|
10.0%
1/10 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ductal breast cancer (Stage 1 )
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
GI Virus
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
herpes labialis
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
influenza
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Infections and infestations
inner ear infection
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
laryngitis
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
poison ivy contact dermatitis
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
rosacea
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Immune system disorders
seasonal allergies
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
sinusitis
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Infections and infestations
sinus congestion
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
strept throat
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Reproductive system and breast disorders
surgery for breast cancer
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
Additional Information
Aida Lugo-Somolinos MD
University of North carolina-Chapel Hill
Phone: 919-843-9447
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place