Efficacy and Safety Study of Tazarotene (Tazorac) for the Treatment of Brittle Nails - Full Text View

Sponsor:	Columbia University
Collaborator:	Allergan
Information provided by:	Columbia University
ClinicalTrials.gov Identifier:	NCT00648986

Purpose

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.

Condition	Intervention	Phase
Brittle Nails	Drug: Tazorac	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Single Center, Open-Label, Efficacy and Safety Study of Tazarotene (Tazorac) for the Treatment of Brittle Nails

Resource links provided by NLM:

Drug Information available for: Tazarotene

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Physician's Global Assessment (PGA) measures the severity of brittle nail symptoms. [ Time Frame: Baseline, Week 12, and Week 24 ] [ Designated as safety issue: No ]
Physician ratings of the roughness, raggedness, and peeling of the target nails. [ Time Frame: All study visits ] [ Designated as safety issue: No ]
A VapoMeter measures the Transonychial Water Loss (TOWL) on both target nails. [ Time Frame: All study visits ] [ Designated as safety issue: No ]
Subject reporting provides the subjects' assessments of their nail breakage. [ Time Frame: All study visits ] [ Designated as safety issue: No ]
Subject reporting provides the subjects' satisfaction with the product. [ Time Frame: Week 12, 24, and 36 ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	August 2005
Study Completion Date:	December 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Uncontrolled, Open-Label Pilot Study	Drug: Tazorac All patients were to apply topical tazarotene (Tazorac) twice daily to all affected fingernails for 24 weeks.

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.

Eligibility

Ages Eligible for Study:	18 Years to 76 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00648986

Locations

United States, New York
Columbia University Medical Center
New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

Allergan

Investigators

Principal Investigator:	Richard Scher, MD	University of North Carolina
Principal Investigator:	Julian Mackay-Wiggan, MD	Columbia University

More Information

No publications provided

Responsible Party:	Columbia University Medical Center ( Richard K. Scher, M.D./Principal Investigator )
Study ID Numbers:	TAZ11-2003, 20041705
Study First Received:	March 27, 2008
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00648986 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Keratolytic Agents
Tazarotene
Therapeutic Uses
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010