Restasis for Treatment of Brittle Nails
|Brittle Nails||Drug: Restasis (cyclosporine ophthalmic emulsion) 0.05% Drug: Refresh® Dry Eye therapy||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Restasis® Ophthalmic Emulsion for the Treatment of Brittle Nails|
- Change From Baseline in the Physician's Global Assessment (PGA) of Target Fingernails #1 and #2 [ Time Frame: Baseline, week 24 ]
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.
- Change From Baseline in Quality of Life (QOL) Related to Nail Disease [ Time Frame: Baseline, week 24 ]Change 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.
- Growth of the Treated and Untreated Nail in the Previous 4 Weeks [ Time Frame: Week 24 ]Growth of the treated and untreated nail the previous 4 weeks. Nail growth was measured in millimeters.
- Number of Subjects Achieving Improvement in the Physician's Global Improvement Assessment (PGIA) [ Time Frame: Week 24 ]Number 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.
|Study Start Date:||July 2009|
|Study Completion Date:||December 2012|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
Drug: Restasis (cyclosporine ophthalmic emulsion) 0.05%
cyclosporine ophthalmic emulsion 0.05%
Other Name: Restasis®
Placebo Comparator: 2
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.
Drug: Refresh® Dry Eye therapy
Emulsion contains glycerin 1% and polysorbate 80
Other Name: Refresh®
This is a single center, investigator-blinded (investigator masked), head to head comparison of Restasis® and its vehicle, Refresh® Dry Eye Therapy in 24 patients. Three target fingernails will be identified in each subject. Two of the target nails will be the two nails that have the most severe signs of brittle nail syndrome. The third target nail will be a normal nail or, in the absence of a normal nail, the patient's second-healthiest appearing nail. The patients most normal-appearing nail will be untreated so that growth in the treated nails can be compared to growth in an untreated normal nail, this will be the fourth target nail. Study medication will be applied to target nails (the subjects may also apply to all nails if they wish, except one nail which will be untreated in order to determine the subject's baseline rate of fingernail growth) for 24 weeks. The target nails will be assessed at each visit, every four weeks. There will be a 12-week follow up period after treatment is completed.
This 36 week study will be conducted at one center. Adult male and female patients meeting the inclusion and exclusion criteria will be screened for eligibility. The principal investigator or his/her designee will obtain informed consent from all patients before any protocol specific procedures are performed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00986427
|United States, New York|
|Columbia University Medical Center Department of Dermatology|
|New York, New York, United States, 10032|
|Principal Investigator:||Julian Mackay Wiggan, MD, MS||Columbia University Medical Center Department of Dermatolgoy|