Topical Cyclosporine Suspension for the Treatment of Brittle Nails

NCT01064830 | Completed Phase 2 Results

• 1 other identifier: 09-1141
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Brittle Nail Syndrome

Keywords

brittle nail

Outcome Measures

Primary Outcomes (1)

• • Number of Patients Receiving at Least a 1-grade Improvement in the Physicians Global Improvement Assessment (PGIA) of Two Target Nails.

  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

  20 weeks

Secondary Outcomes (1)

• Patients Assessment of Satisfaction With Length of Fingernails

  20 weeks

Study Arms (2)

topical cyclosporine suspension

ACTIVE COMPARATOR

apply 2 drops to 2 target nails under occlusion daily for 20 weeks

Drug: topical cyclosporine ophthalmic suspension 0.05%

vehicle

PLACEBO COMPARATOR

apply to target nails daily under occlusion daily for 20 weeks

Drug: vehicle

Interventions

topical cyclosporine ophthalmic suspension 0.05% DRUG

apply 2 drops to 2 target fingernails under occlusion daily

Also known as: Restasis

topical cyclosporine suspension

vehicle DRUG

apply 2 drops to 2 target fingernails under occlusion daily for 20 weeks

Also known as: Refresh Dry Eye Therapy

vehicle

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must understand and voluntarily sign an informed consent form
• Must be male or female and aged 18-75 years at time of consent
• Must be able to adhere to the study visit schedule and other protocol requirements
• At least 2 of the following: raggedness (fraying of the distal edge), splitting, and peeling (lamellar onychoschizia) of 2 target fingernails of the same hand. If the subject does not have 2 fingernails affected in the same hand, a second fingernail on the other hand may be used as control.
• A direct microscopic examination with potassium hydroxide (KOH)/calcofluor that is negative for hyphae associated with dermatophytes
• Women of childbearing potential must have a negative pregnancy test at enrollment

You may not qualify if:

• Inability to provide voluntary consent
• Pregnant or breastfeeding
• Fingernail fungal infection
• Use of any investigational medication within 4 weeks prior to start of study drug
• Subject has any known immunodeficiency or history of malignancy in the last 4 years, excluding nonmelanoma skin cancer.
• Use of any topical nail medication for 2 weeks
• Use of any topical nail product (nail polish, hardeners, acetone, etc) for 1 week prior to and during the study.
• Use of biotin 2 weeks before enrollment.
• No genetic nail abnormalities
• Known sensitivity to Restasis® or RDET®.
• Subject has psoriasis, lichen planus, or other abnormalities that could result in a clinically abnormal fingernail

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Allergan: collaborator

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27516, United States

Location

MeSH Terms

Conditions

Twenty-Nail Dystrophy

Interventions

Cyclosporins

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Aida Lugo-Somolinos MD
• Organization: University of North carolina-Chapel Hill

alugosom@med.unc.edu

919-843-9447

Study Officials

• Aida Lugo-Somolinos, MD

  UNC- Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 5, 2010
• First Posted: February 8, 2010
• Study Start: February 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: March 13, 2017
• Results First Posted: December 3, 2012

Record last verified: 2017-02

Locations

US (1)