Restasis for Treatment of Brittle Nails

NCT00986427 | Completed Phase 2 Results

• 2 other identifiers: AAAD9927Res-01-2009
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brittle Nails

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

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%

2

PLACEBO COMPARATOR

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

Interventions

Restasis (cyclosporine ophthalmic emulsion) 0.05% DRUG

cyclosporine ophthalmic emulsion 0.05%

Also known as: Restasis®

1

Refresh® Dry Eye therapy DRUG

Emulsion contains glycerin 1% and polysorbate 80

Also known as: Refresh®

2

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 have IRB approved written informed consent prior to participating in any study related procedures
• Must be a male or female patient 18 to 75 years of age
• must have a diagnosis of brittle or meet the criteria for a diagnosis of brittle nails at the screening visit based on at least two of the following signs and symptoms of brittle nails in each of the selected nail plates or severe signs (one or more) on each target nail
• trachyonychia (surface roughness)
• lamellar onychoschizia (horizontal layering/peeling
• longitudinal cracking or splitting of the distal edge (raggedness)
• must have two fingernails with brittle nail signs and symptoms identified at baseline
• must have two normal or near-normal nails on the same hand
• female patients of childbearing potential (not surgically sterile or at least 2 years postmenopausal) must have a negative pregnancy at baseline/day 1 and may not be lactating
• sexually active female subjects who are not surgically sterile or 2 years post menopausal must agree to use contraception/birth control measure while on study (e.g., oral contraceptive, diaphragms with spermicide, condoms with spermicide, intrauterine devices, Norplant System, Depo-Provera, tubal ligation). Monthly urine pregnancy tests will be administered to women of childbearing potential
• must agree to self administer topical study medication, and must agree to complete all study procedures
• must be judged to be in good health by medical history and physical examination
• must be able to adhere to the study visit schedule and other protocol requirements, including avoiding the use of nail polish, adhesive nails, and manicures for the duration of the study

You may not qualify if:

• have a history of surgery of the affected fingernails
• are chronic nail biters
• are pregnant, nursing, or planning pregnancy prior to study enrollment
• have a disturbance of the shape of the affected fingernails (e.g., due to malformation of the underlying bone) that would interfere with the investigator's ability to evaluate photographs or nail changes
• have onycholysis (lifting of the nail plate off the nail bed) of the affected fingernails
• have signs of a fungal or bacterial infection of the affected fingernails
• have a history of psoriasis or lichen planus involving any nail, or active contact dermatitis involving the affected fingernails
• have used any topical cosmetics or medicated products on the affected nails within 2 weeks of baseline visit
• have received oral antifungal treatment within 3 months of baseline visit
• have a known or suspected history of a genetic condition affecting the nails (e.g., Darier's disease, nail-patella syndrome, tuberous sclerosis)
• have used any investigational drug within the previous 1 month or 5 half-lives of the investigational agent, whichever is longer, or 3 months for any biologic of unknown half-life
• are known or suspected to have had a substance abuse (drug or alcohol) problem within the previous 3 years
• is unlikely to comply with the study protocol and prescribed treatment or is unsuitable for any other reason in the opinion of the investigator
• chronic liver, heart, kidney, or (untreated) thyroid disease
• have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease

Sponsors & Collaborators

• Julian M. Mackay-Wiggan: lead
• Allergan: collaborator

Study Sites (1)

Columbia University Medical Center Department of Dermatology

New York, New York, 10032, 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

Limitations and Caveats

Small Sample Size

Results Point of Contact

• Title: Julian Mackay-Wiggan, MD
• Organization: Columbia University Dept of Dermatology

jc299@columbia.edu

212-305-6953

Study Officials

• Julian Mackay Wiggan, MD, MS

  Columbia University Medical Center Department of Dermatolgoy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• 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: SPONSOR INVESTIGATOR
• PI Title: Assistant Clinical Professor of Dermatology

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: September 30, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: December 1, 2012
• Last Updated: August 20, 2013
• Results First Posted: August 20, 2013

Record last verified: 2013-07

Locations

US (1)