Status:
COMPLETED
Restasis for Treatment of Brittle Nails
Lead Sponsor:
Julian M. Mackay-Wiggan
Collaborating Sponsors:
Allergan
Conditions:
Brittle Nails
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 th...
Detailed Description
This is a single center, investigator-blinded (investigator masked), head to head comparison of Restasis® and its vehicle, Refresh® Dry Eye Therapy in 24 patients. Three target fingernails will be ide...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- currently have any known malignancy or have a history of malignancy other than non-melanoma skin cancer
- have signs of bacterial, fungal or viral skin lesions that may interfere with evaluation of the target nails
- known sensitivity to any active or inactive ingredient in Restasis(R) or Refresh(R) Dry Eye Therapy
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00986427
Start Date
July 1 2009
End Date
December 1 2012
Last Update
August 20 2013
Active Locations (1)
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1
Columbia University Medical Center Department of Dermatology
New York, New York, United States, 10032