Efficacy and Safety Study of Tazarotene (Tazorac) for the Treatment of Brittle Nails

NCT00648986 | Completed Phase 4

• 2 other identifiers: AAAA5735TAZ11-2003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brittle Nails

Keywords

brittle nails; Tazarotene; Tazorac

Outcome Measures

Primary Outcomes (1)

• 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.

  Weeks 12, 24, and 36

Secondary Outcomes (5)

• Physician's Global Assessment (PGA) measures the severity of brittle nail symptoms.

  Baseline, Week 12, and Week 24

• Physician ratings of the roughness, raggedness, and peeling of the target nails.

  All study visits

• A VapoMeter measures the Transonychial Water Loss (TOWL) on both target nails.

  All study visits

• Subject reporting provides the subjects' assessments of their nail breakage.

  All study visits

• Subject reporting provides the subjects' satisfaction with the product.

  Week 12, 24, and 36

Study Arms (1)

1

EXPERIMENTAL

Uncontrolled, Open-Label Pilot Study

Drug: Tazorac

Interventions

Tazorac DRUG

All patients were to apply topical tazarotene (Tazorac) twice daily to all affected fingernails for 24 weeks.

Also known as: Tazarotene

1

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Columbia University: lead
• Allergan: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Twenty-Nail Dystrophy

Interventions

tazarotene

Study Officials

• Richard Scher, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

• Julian Mackay-Wiggan, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 27, 2008
• First Posted: April 1, 2008
• Study Start: August 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: July 2, 2014

Record last verified: 2014-06

Locations

US (1)