Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
NCT ID: NCT00443898
Last Updated: 2012-05-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
518 participants
INTERVENTIONAL
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
terbinafine
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 48 weeks
2
vehicle (placebo) applied once daily for 48 weeks
Placebo
vehicle (placebo) applied once daily for 48 weeks
3
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
terbinafine
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 24 weeks
4
vehicle (placebo) applied once daily for 24 weeks
Placebo
vehicle (placebo) applied once daily for 24 weeks
Interventions
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terbinafine
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 48 weeks
Placebo
vehicle (placebo) applied once daily for 48 weeks
terbinafine
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 24 weeks
Placebo
vehicle (placebo) applied once daily for 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
75 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Dr. Boni Elewski
Birmingham, Alabama, United States
Dr. Stacy Smith
San Diego, California, United States
Dr. James Swinehart
Denver, Colorado, United States
Dr. David G. Armstrong
North Chicago, Illinois, United States
Dr. Kevin Terry
Lutherville, Maryland, United States
Dr. Anthony Puopolo
Milford, Massachusetts, United States
Dr. John Fenyk
Chaska, Minnesota, United States
Dr. Joel Schlessinger
Omaha, Nebraska, United States
Dr. AnneMarie Uliasz
New York, New York, United States
Dr. Willard Niemi
Raleigh, North Carolina, United States
Dr. Diane Baker
Lake Oswego, Oregon, United States
Dr. John Barnes
Portland, Oregon, United States
Dr. Harry Penny
Altoona, Pennsylvania, United States
Dr. Lawrence Parish
Philadelphia, Pennsylvania, United States
Dr. Cynthia Strout
Mt. Pleasant, South Carolina, United States
Dr. Teresa Coats
Austin, Texas, United States
Dr. Scott J. Ashton
Dallas, Texas, United States
Dr. Amit Pandya
Dallas, Texas, United States
Dr. Lawrence Harkless
San Antonio, Texas, United States
Dr. Robert Shouey
Harrisonburg, Virginia, United States
Novartis Investigative Site
Various Cities, , Canada
Novartis Investigative Site
Various Cities, , Iceland
Countries
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Other Identifiers
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CSFO327N2301
Identifier Type: -
Identifier Source: org_study_id
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