- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00648986
Efficacy and Safety Study of Tazarotene (Tazorac) for the Treatment of Brittle Nails
June 30, 2014 updated by: Columbia University
Single Center, Open-Label, Efficacy and Safety Study of Tazarotene (Tazorac) for the Treatment of Brittle Nails
The purpose of this study is to determine whether topical tazarotene (Tazorac), a receptor-selective synthetic retinoid that normalizes epidermal differentiation, ameliorates signs and symptoms of brittle nails.
Study Overview
Detailed Description
"Brittle nails," referring to nails that chip, peel, or split excessively, occur in up to 30% of women and 15% of men, with highest prevalence among the elderly.
Treatment of brittle nails involves restoration and maintenance of a normal degree of nail plate hydration by minimizing exposure to dehydrating chemicals and by use of moisturizers, such as alpha-hydroxy acids.
Retinoids are vitamin A analogs that play a role in skin cell differentiation and proliferation.
Tazarotene is a topical receptor-selective synthetic retinoid that normalizes epidermal differentiation and reduces the influx of inflammatory cells into the skin.
In this single-center, open-label trial, subjects applied tazarotene to the nails twice daily for 24 weeks.
Signs and symptoms were rated by the investigators and subjects during treatment and 12 weeks after discontinuation.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 76 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient has provided IRB-approved written informed consent prior to conducting any study-related procedures
- Men and female patients 18 to 75 years of age
- Have had a diagnosis of brittle nails
- Have two target fingernails identified at baseline
- Have evidence of 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)
- longitudinal cracking or splitting of the distal edge
- Female patient of childbearing potential (not surgically sterile or at least 2 years postmenopausal) has a negative pregnancy test at baseline/day 1 and is not lactating
- Sexually active female subject who is not surgically sterile or 2 years post menopausal must agree to use contraception/birth control measure while on study (e.g., oral contraceptives, diaphragms with spermicide, condoms with spermicide, intrauterine devices, Norplant System, Depo-Provera, tubal ligation)
- Patients will agree to self-administer topical study medication, and will agree to complete all study procedures
- Patient is 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
Exclusion Criteria:
- Have a history of surgery of the affected fingernails
- 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
- Have onycholysis (lifting of the nail plate off the nailbed) of the affected fingernails
- Have a fungal 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, tuberculosis sclerosis)
- Immune compromise due to HIV infection, organ transplantation, or treatment of malignancy
- Chronic liver, heart, kidney, or ( untreated) thyroid disease
- 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 to have had a substance abuse (drug or alcohol) problem within the previous 3 years
- Unlikely to comply with the study protocol and prescribed treatment or is unsuitable for any other reason in the opinion of the investigator
- 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
- Are known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C
- Have signs of bacterial, fungal or viral skin lesions that may interfere with measurement of the target lesions.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Uncontrolled, Open-Label Pilot Study
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All patients were to apply topical tazarotene (Tazorac) twice daily to all affected fingernails for 24 weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary endpoint was the change in the Physician's Global Improvement Assessment (PGIA) of the 2 target nails. The PGIA score reflects the comparison of photographs taken at baseline to the nails at 12 weeks, 24 weeks, and 36 weeks.
Time Frame: Weeks 12, 24, and 36
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Weeks 12, 24, and 36
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Physician's Global Assessment (PGA) measures the severity of brittle nail symptoms.
Time Frame: Baseline, Week 12, and Week 24
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Baseline, Week 12, and Week 24
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Physician ratings of the roughness, raggedness, and peeling of the target nails.
Time Frame: All study visits
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All study visits
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A VapoMeter measures the Transonychial Water Loss (TOWL) on both target nails.
Time Frame: All study visits
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All study visits
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Subject reporting provides the subjects' assessments of their nail breakage.
Time Frame: All study visits
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All study visits
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Subject reporting provides the subjects' satisfaction with the product.
Time Frame: Week 12, 24, and 36
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Week 12, 24, and 36
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard Scher, MD, University of North Carolina
- Principal Investigator: Julian Mackay-Wiggan, MD, Columbia University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2005
Primary Completion (Actual)
December 1, 2006
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
March 27, 2008
First Submitted That Met QC Criteria
March 27, 2008
First Posted (Estimate)
April 1, 2008
Study Record Updates
Last Update Posted (Estimate)
July 2, 2014
Last Update Submitted That Met QC Criteria
June 30, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAA5735
- TAZ11-2003 (Other Identifier: Allergan)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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