Restasis for Treatment of Brittle Nails
Restasis® Ophthalmic Emulsion for the Treatment of Brittle Nails
Sponsor study identifier
Secondary identifiers
OTHER · Protocol number
interventional
24
1 country
1
Study Start
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2010
Actual (reported)Study Completion
December 2012
Actual (reported)This purpose of this study is to assess the safety and effectiveness of Restasis® ophthalmic emulsion versus emulsion alone( Refresh Dry Eye therapy) both for the treatment of brittle nails and for the enhancement of normal nail growth and texture. The investigators think that daily application of Restasis® to nails and nail beds in patients with brittle nails will enhance nail growth and improve nail texture in both affected and unaffected nails.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
September 29, 2009
Actual (reported)September 30, 2009
Actual (reported)July 2010
Actual (reported)December 2012
Actual (reported)August 20, 2013
Actual (reported)Change From Baseline in the Physician's Global Assessment (PGA) of Target Fingernails #1 and #2
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.
Baseline, week 24
Change From Baseline in Quality of Life (QOL) Related to Nail Disease
Baseline, week 24
Growth of the Treated and Untreated Nail in the Previous 4 Weeks
Week 24
Number of Subjects Achieving Improvement in the Physician's Global Improvement Assessment (PGIA)
Week 24
Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
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.
cyclosporine ophthalmic emulsion 0.05%
Emulsion contains glycerin 1% and polysorbate 80
Columbia University Medical Center Department of Dermatology
New York, New York, 10032, United States
Small Sample Size
Julian Mackay Wiggan, MD, MS
Columbia University Medical Center Department of Dermatolgoy
24 participants (actual enrollment reported by the registry).
First Submitted
September 29, 2009
First Posted
September 30, 2009
Study Start
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
July 2010
Actual (reported)Study Completion
December 2012
Actual (reported)Last Updated
August 20, 2013
Results First Posted
August 20, 2013
Record last verified: 2013-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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