Restasis for Treatment of Brittle Nails

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00986427
• Date of registration: 29/09/2009
• Primary sponsor: Columbia University
• Public title: Restasis for Treatment of Brittle Nails
• Scientific title: Restasis (R) Ophthalmic Emulsion for the Treatment of Brittle Nails
• Date of first enrolment: July 2009
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00986427
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Julian Mackay Wiggan, MD, MS
• Affiliation: Columbia University Medical Center Department of Dermatolgoy

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Brittle Nails

Intervention(s)

Drug: Refresh(R) Dry Eye therapy

Drug: Restasis (cyclosporine ophthalmic emulsion) 0.05%

Primary Outcome(s)

Primary endpoint will be the proportion of patients achieving improvement in the Physician's Global Assessment (PGA), which is a measure of the severity of brittle nail symptoms in three target nails at baseline, and 4, 8, 12, 16, 20, 24, and 36 weeks. [Time Frame: baseline and 4, 8, 12, 16, 20, 24, and 36 weeks]

Secondary Outcome(s)

Secondary outcomes will include improvement in quality of life as measured by the patient satisfaction questionnaire, nail growth from baseline and the Physician's Global Improvement Assessment (PGIA) of the three target nails. [Time Frame: baseline and 4, 8, 12, 16, 20, 24 and 36 weeks]

Secondary ID(s)

AAAD9927

Res-01-2009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Allergan