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

May 1, 2012 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

518

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
Drug: terbinafine
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 48 weeks
Other Names:
  • Lamisil
Drug: terbinafine
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 24 weeks
Other Names:
  • Lamisil
Placebo Comparator: 2
vehicle (placebo) applied once daily for 48 weeks
Drug: Placebo
vehicle (placebo) applied once daily for 48 weeks
Drug: Placebo
vehicle (placebo) applied once daily for 24 weeks
Experimental: 3
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
Drug: terbinafine
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 48 weeks
Other Names:
  • Lamisil
Drug: terbinafine
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 24 weeks
Other Names:
  • Lamisil
Placebo Comparator: 4
vehicle (placebo) applied once daily for 24 weeks
Drug: Placebo
vehicle (placebo) applied once daily for 48 weeks
Drug: Placebo
vehicle (placebo) applied once daily for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks.
Time Frame: 52 weeks

Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes.

and no residual involvement of the target toenail. The complete cure was a composite binary variable defined as "Yes" if:

  • Mycological cure (negative KOH and negative culture for dermatophytes) and
  • No residual involvement of the target toenail "No" if otherwise
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 24 or 48 Weeks.
Time Frame: 52 weeks

Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes.

Mycological cure was a composite binary variable defined as "Yes"if :

  • Negative microscopy and
  • Negative culture for dermatophytes "No" if otherwise.
52 weeks
Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 24 or 48 Weeks.
Time Frame: 52 weeks

Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and <= 10% residual involvement of the target toenail.

Clinical effectiveness was a composite binary variable defined as "Yes" if

  • Mycological cure (negative KOH and negative culture for dermatophytes) and
  • = 10% residual involvement of the target toenail "No" if otherwise
52 weeks
Number of Participants Assessed With Adverse Events and Serious Adverse Events
Time Frame: 52 weeks

An adverse event (AE) is any adverse change in health or side effect that occurs while the participant is receiving the treatment or within a previously specified period of time after the treatment has been completed.

A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening requires, inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage.
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

March 5, 2007

First Submitted That Met QC Criteria

March 6, 2007

First Posted (Estimate)

March 7, 2007

Study Record Updates

Last Update Posted (Estimate)

May 3, 2012

Last Update Submitted That Met QC Criteria

May 1, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSFO327N2301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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