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NCT01064830 · ClinicalTrials.gov registry record · Phase 2
Topical Cyclosporine Suspension for the Treatment of Brittle Nails
A Phase 2 study of Brittle Nail Syndrome, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT01064830: Completed Phase 2 study of Brittle Nail Syndrome, sponsored by University of North Carolina, Chapel Hill.
NCT01064830 is a Phase 2 study of Brittle Nail Syndrome that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01064830, a Phase 2 study of Brittle Nail Syndrome, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
Brittle nail syndrome (BNS) refers to nails that exhibit splitting, raggedness (fraying of the distal edge), and peeling (lamellar onychoschizia).(1) This is a common problem, affecting approximately 20% of women, with higher prevalence among the elderly.(2) A number of factors have been proposed as possible causes of nail brittleness, such as anemia, biotin deficiency, or cysteine deficiency. (3,4) However, most authors believe that brittle nails are usually caused by dehydration of the nail plate, either from repetitive cycles of hydration and dehydration related to hand washing or from exposure to dehydrating chemicals, such as those found in nail enamel and cuticle removers. (5,6) Inflammation of the nail as a potential contributing factor has never been studied. There are currently not consistently effective treatments for this condition. Restasis® is effective in treating keratoconjunctivitis sicca. This condition is characterized by the troublesome condition of dry eyes partially due to decreased tear production exacerbated by inflammation. The BNS manifests itself by nail plate dehydration. The two conditions have in common disruption of water balance which gives rise to problematic clinical disorders. The hypothesis is that a product which benefits tear production would also be effective for brittle nails which contain roughly 15% water.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG topical cyclosporine ophthalmic suspension 0.05%
- DRUG vehicle
Study Locations (1)
North Carolina
- University of North Carolina - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2010-02 |
| Est. Completion | 2011-08 |
| Phase | Phase 2 |
What the finished NCT01064830 record still lists
NCT01064830 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Brittle Nail Syndrome appearing as the primary indexed condition, and to 2 interventions - of which topical cyclosporine ophthalmic suspension 0.05% is the first listed.
NCT01064830 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01064830 about?
NCT01064830 is a clinical study titled "Topical Cyclosporine Suspension for the Treatment of Brittle Nails". Brittle nail syndrome (BNS) refers to nails that exhibit splitting, raggedness (fraying of the distal edge), and peeling (lamellar onychoschizia).(1) This is a common problem, affecting approximately 20% of women, with higher prevalence among the elderly.(2) A number of factors have been proposed as...
What is the current status of trial NCT01064830?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2010-02. Estimated completion is 2011-08.
What conditions does trial NCT01064830 study?
This clinical trial studies the following conditions: Brittle Nail Syndrome.
What interventions are being tested in trial NCT01064830?
The interventions under investigation include: topical cyclosporine ophthalmic suspension 0.05% (DRUG), vehicle (DRUG).
Who is sponsoring clinical trial NCT01064830?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01064830 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01064830's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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