Efficacy Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
NCT ID: NCT00443820
Last Updated: 2011-04-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
526 participants
INTERVENTIONAL
2006-12-31
2008-06-30
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
Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
terbinafine
Terbinafine hydrochloride (HCl) 10 % nail solution for onychomycosis (NSO) once daily for 48 weeks
2
Vehicle (placebo) for 48 weeks
Placebo
Vehicle (placebo) once daily for 48 weeks
3
Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
terbinafine
Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis once daily for 24 weeks
4
Vehicle (placebo) for 24 weeks
Placebo
Vehicle (placebo) once daily for 24 weeks
Interventions
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terbinafine
Terbinafine hydrochloride (HCl) 10 % nail solution for onychomycosis (NSO) once daily for 48 weeks
Placebo
Vehicle (placebo) once daily for 48 weeks
terbinafine
Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis once daily for 24 weeks
Placebo
Vehicle (placebo) 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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Novartis Pharmaceuticals
Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Dr. Fred D. Youngswick
Novato, California, United States
Dr. Larry Doehring
Northglenn, Colorado, United States
Dr. Robert P. Dunne
Melbourne, Florida, United States
Dr. Mark Ling
Newnan, Georgia, United States
Dr. Jesse Plasencia
Chicago, Illinois, United States
Dr. John Mallory
Overland Park, Kansas, United States
Dr. Jeffrey Conrow
Topeka, Kansas, United States
Dr.Michael Kaye
Covington, Louisiana, United States
Dr. Max Weisfeld
Baltimore, Maryland, United States
Dr. Linda Stein-Gold
Detroit, Michigan, United States
Dr. Anna Glaser
St Louis, Missouri, United States
Dr. Richard Scher
New York, New York, United States
Dr. Joseph Jorrizo
Winston-Salem, North Carolina, United States
Dr. Anne Lucky
Cincinnati, Ohio, United States
Dr. Rich Phoebe
Portland, Oregon, United States
Dr. Patricia Westmorland
Simpsonville, South Carolina, United States
Dr. David Horowitz
Nashville, Tennessee, United States
Dr. Jay Lifshen
Irving, Texas, United States
Dr. Richard Pollak
San Antonio, Texas, United States
Dr. Patrick Agnew
Virginia Beach, Virginia, United States
Novartis Investigative Site
Various Cities, , France
Novartis
Investigative Site, , Germany
Novartis Investigative Site
Various Cities, , Germany
Countries
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Other Identifiers
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CSFO327N2302
Identifier Type: -
Identifier Source: org_study_id
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