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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 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. The trial reports 1 study location across 1 state.

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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.

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

FieldValue
Enrollment Target 21 participants
Start Date 2010-02
Est. Completion 2011-08
Phase Phase 2

What the Registry Record Tells You About NCT01064830

The ClinicalTrials.gov registry entry for NCT01064830 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.