Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Onychomycosis
Intervention: terbinafine (Drug); Placebo (Drug); terbinafine (Drug); Placebo (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals, One Health Plaza, East Hanover, NJ 07936-1080, Tel.: 862-778-8300
Summary
This study is designed to assess the efficacy, safety and tolerability of a topical
formulation of terbinafine solution applied daily in patients with toenail fungus. This
trial will study patients with mild to moderate toenail fungus disease of the big toenail and
their responses to two treatment durations, 24 or 48 weeks.
Clinical Details
Official title: A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of Topical Terbinafine Hydrogen Chloride (HCl) Formulation for 24 or 48 Weeks of Treatment in Patients With Mild to Moderate Toenail Onychomycosis
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Efficacy assessed by complete cure rate (negative culture, negative KOH microscopy and no residual disease involvement)at the end of study (week 52) after treating for 24 or 48 weeks.
Secondary outcome: Efficacy assessed by mycological cure (negative culture and negative KOH microscopy) and clinical efficacy (less than 10% residual disease involvement) at the end of study after treating patients for 24 or 48 weeks.Safety assessed by adverse events.
Eligibility
Minimum age: 12 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male and females 12 - 75 years of age
- Fungal toenail infection of one or both of the large (great) toenails
- The nail infection must be due to a dermatophyte, (mixed infections [dermatophyte and
non-dermatophyte] are not allowed)
Exclusion Criteria:
- Target foot must not have severe plantar (moccasin) tinea pedis that would require
systemic therapy. Mild to moderate tinea pedis (athlete's foot) infection should be
treated with terbinifine prior to baseline or at any time during the trial. Other
topical treatments for athlete's foot may be recommended at the discretion of the
investigator.
- Subjects must not have abnormalities of the nail that could prevent a normal appearing
nail if clearing of infection is achieved
- No administration of systemic antifungal medications within 6 months prior to
screening visit
- No application of prescription topical antifungal medications for toenail fungus
within 3 months or other commercially available topical medications for toenail fungus
applied directly to the toenails within 1 month prior to screening visit
- No professional pedicures or application of any nail polish product or nail cosmetic
to the toenails after the screening visit
- Known pregnancy or lactation at time of enrollment
Other protocol-defined inclusion/exclusion criteria may apply
Locations and Contacts
Novartis Investigative Site, Various cities, Canada
Novartis Investigative Site, Various cities, Iceland
Dr. Boni Elewski, Birmingham, Alabama 35233, United States
Dr. Stacy Smith, San Diego, California 92123, United States
Dr. James Swinehart, Denver, Colorado 80210, United States
Dr. David G. Armstrong, North Chicago, Illinois 60064, United States
Dr. Kevin Terry, Lutherville, Maryland 21093, United States
Dr. Anthony Puopolo, Milford, Massachusetts 01757, United States
Dr. John Fenyk, Chaska, Minnesota 55318, United States
Dr. Joel Schlessinger, Omaha, Nebraska 68144, United States
Dr. AnneMarie Uliasz, New York, New York 10029, United States
Dr. Willard Niemi, Raleigh, North Carolina 27615, United States
Dr. John Barnes, Portland, Oregon 97205, United States
Dr. Diane Baker, Lake Oswego, Oregon 97035, United States
Dr. Lawrence Parish, Philadelphia, Pennsylvania 19103, United States
Dr. Harry Penny, Altoona, Pennsylvania 16602, United States
Dr. Cynthia Strout, Mt. Pleasant, South Carolina 29464, United States
Dr. Amit Pandya, Dallas, Texas 75390-8802, United States
Dr. Scott J. Ashton, Dallas, Texas 75243, United States
Dr. Teresa Coats, Austin, Texas 78705, United States
Dr. Lawrence Harkless, San Antonio, Texas 78207, United States
Dr. Robert Shouey, Harrisonburg, Virginia 22801, United States
Additional Information
Click here to get more information on this study.
Starting date: December 2006
Ending date: July 2008
Last updated: February 15, 2008
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