Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail - Full Text View

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00443898

Purpose

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.

Condition	Intervention	Phase
Onychomycosis	Drug: terbinafine Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Fungal Infections Molds

Drug Information available for: Terbinafine hydrochloride Terbinafine

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy assessed by mycological cure (negative culture and negative KOH microscopy) and clinical efficacy (less than or equal to 10% residual disease involvement) at the end of study after treating patients for 24 or 48 weeks. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Safety assessed by adverse events, serious adverse events, hematology and chemistry. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	518
Study Start Date:	December 2006
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks	Drug: terbinafine Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 48 weeks
2: Placebo Comparator vehicle (placebo) for 48 weeks	Drug: Placebo vehicle (placebo) once daily for 48 weeks
3: Experimental Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks	Drug: terbinafine Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 24 weeks
4: Placebo Comparator vehicle (placebo) for 24 weeks	Drug: Placebo vehicle (placebo) once daily for 24 weeks

Eligibility

Ages Eligible for Study:	12 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443898

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Locations

United States, Alabama
Dr. Boni Elewski
Birmingham, Alabama, United States, 35233
United States, California
Dr. Stacy Smith
San Diego, California, United States, 92123
United States, Colorado
Dr. James Swinehart
Denver, Colorado, United States, 80210
United States, Illinois
Dr. David G. Armstrong
North Chicago, Illinois, United States, 60064
United States, Maryland
Dr. Kevin Terry
Lutherville, Maryland, United States, 21093
United States, Massachusetts
Dr. Anthony Puopolo
Milford, Massachusetts, United States, 01757
United States, Minnesota
Dr. John Fenyk
Chaska, Minnesota, United States, 55318
United States, Nebraska
Dr. Joel Schlessinger
Omaha, Nebraska, United States, 68144
United States, New York
Dr. AnneMarie Uliasz
New York, New York, United States, 10029
United States, North Carolina
Dr. Willard Niemi
Raleigh, North Carolina, United States, 27615
United States, Oregon
Dr. John Barnes
Portland, Oregon, United States, 97205
Dr. Diane Baker
Lake Oswego, Oregon, United States, 97035
United States, Pennsylvania
Dr. Lawrence Parish
Philadelphia, Pennsylvania, United States, 19103
Dr. Harry Penny
Altoona, Pennsylvania, United States, 16602
United States, South Carolina
Dr. Cynthia Strout
Mt. Pleasant, South Carolina, United States, 29464
United States, Texas
Dr. Amit Pandya
Dallas, Texas, United States, 75390-8802
Dr. Scott J. Ashton
Dallas, Texas, United States, 75243
Dr. Teresa Coats
Austin, Texas, United States, 78705
Dr. Lawrence Harkless
San Antonio, Texas, United States, 78207
United States, Virginia
Dr. Robert Shouey
Harrisonburg, Virginia, United States, 22801
Canada
Novartis Investigative Site
Various cities, Canada
Iceland
Novartis Investigative Site
Various cities, Iceland

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Additional Information:

Click here to get more information on this study. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CSFO327N2301
Study First Received:	March 5, 2007
Last Updated:	August 3, 2009
ClinicalTrials.gov Identifier:	NCT00443898 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Iceland: Ministry of Health and Social Security

Keywords provided by Novartis:

Toenail fungus
Onychomycosis
Nail fungus
Toenail fungal infection

Tinea unguium
Dermatophytes
Foot dermatoses

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Enzyme Inhibitors
Infection
Pharmacologic Actions
Mycoses
Skin Diseases, Infectious

Onychomycosis
Nail Diseases
Antifungal Agents
Therapeutic Uses
Tinea
Dermatomycoses
Terbinafine

ClinicalTrials.gov processed this record on November 22, 2009