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:	NCT00443820

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 effectiveness (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:	526
Study Start Date:	December 2006
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks	Drug: terbinafine 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 Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks	Drug: terbinafine Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis 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 terbinafine 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: NCT00443820

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Locations

United States, California
Dr. Fred D. Youngswick
Novato, California, United States, 94945
United States, Colorado
Dr. Larry Doehring
Northglenn, Colorado, United States, 80234
United States, Florida
Dr. Robert P. Dunne
Melbourne, Florida, United States, 32935
United States, Georgia
Dr. Mark Ling
Newnan, Georgia, United States, 30263
United States, Illinois
Dr. Jesse Plasencia
Chicago, Illinois, United States, 60632
United States, Kansas
Dr. Jeffrey Conrow
Topeka, Kansas, United States, 66606
Dr. John Mallory
Overland Park, Kansas, United States, 66215
United States, Louisiana
Dr.Michael Kaye
Covington, Louisiana, United States, 70433
United States, Maryland
Dr. Max Weisfeld
Baltimore, Maryland, United States, 21214
United States, Michigan
Dr. Linda Stein-Gold
Detroit, Michigan, United States, 48202
United States, Missouri
Dr. Anna Glaser
St. Louis, Missouri, United States, 63104
United States, New York
Dr. Richard Scher
New York, New York, United States, 10032
United States, North Carolina
Dr. Joseph Jorrizo
Winston Salem, North Carolina, United States, 27157
United States, Ohio
Dr. Anne Lucky
Cincinnati, Ohio, United States, 45230
United States, Oregon
Dr. Rich Phoebe
Portland, Oregon, United States, 97210
United States, South Carolina
Dr. Patricia Westmorland
Simpsonville, South Carolina, United States, 29681
United States, Tennessee
Dr. David Horowitz
Nashville, Tennessee, United States, 37203
United States, Texas
Dr. Richard Pollak
San Antonio, Texas, United States, 78229
Dr. Jay Lifshen
Irving,, Texas, United States, 75061
United States, Virginia
Dr. Patrick Agnew
Virginia Beach, Virginia, United States, 23464
France
Novartis Investigative Site
Various Cities, France
Germany
Novartis Investigative Site
Various cities, Germany
Novartis
Investigative Site, Germany

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:	CSFO327N2302
Study First Received:	March 2, 2007
Last Updated:	June 8, 2009
ClinicalTrials.gov Identifier:	NCT00443820 History of Changes
Health Authority:	United States: Food and Drug Administration; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices

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 27, 2009