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

Primary Purpose

Onychomycosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
terbinafine
Placebo
terbinafine
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onychomycosis focused on measuring Toenail fungus, Onychomycosis, Nail fungus, Toenail fungal infection, Tinea unguium, Dermatophytes, Foot dermatoses

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr. Boni Elewski
  • Dr. Stacy Smith
  • Dr. James Swinehart
  • Dr. David G. Armstrong
  • Dr. Kevin Terry
  • Dr. Anthony Puopolo
  • Dr. John Fenyk
  • Dr. Joel Schlessinger
  • Dr. AnneMarie Uliasz
  • Dr. Willard Niemi
  • Dr. Diane Baker
  • Dr. John Barnes
  • Dr. Harry Penny
  • Dr. Lawrence Parish
  • Dr. Cynthia Strout
  • Dr. Teresa Coats
  • Dr. Scott J. Ashton
  • Dr. Amit Pandya
  • Dr. Lawrence Harkless
  • Dr. Robert Shouey
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks

vehicle (placebo) applied once daily for 48 weeks

Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks

vehicle (placebo) applied once daily for 24 weeks

Outcomes

Primary Outcome Measures

Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 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

Secondary Outcome Measures

Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 24 or 48 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.
Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 24 or 48 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
Number of Participants Assessed With Adverse Events and Serious Adverse Events
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.

Full Information

First Posted
March 5, 2007
Last Updated
May 1, 2012
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00443898
Brief Title
Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
Keywords
Toenail fungus, Onychomycosis, Nail fungus, Toenail fungal infection, Tinea unguium, Dermatophytes, Foot dermatoses

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
518 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
vehicle (placebo) applied once daily for 48 weeks
Arm Title
3
Arm Type
Experimental
Arm Description
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
vehicle (placebo) applied once daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
terbinafine
Other Intervention Name(s)
Lamisil
Intervention Description
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
vehicle (placebo) applied once daily for 48 weeks
Intervention Type
Drug
Intervention Name(s)
terbinafine
Other Intervention Name(s)
Lamisil
Intervention Description
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
vehicle (placebo) applied once daily for 24 weeks
Primary Outcome Measure Information:
Title
Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks.
Description
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
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 24 or 48 Weeks.
Description
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.
Time Frame
52 weeks
Title
Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 24 or 48 Weeks.
Description
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
Time Frame
52 weeks
Title
Number of Participants Assessed With Adverse Events and Serious Adverse Events
Description
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.
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Dr. Boni Elewski
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Dr. Stacy Smith
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Dr. James Swinehart
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Dr. David G. Armstrong
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
Facility Name
Dr. Kevin Terry
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
Dr. Anthony Puopolo
City
Milford
State/Province
Massachusetts
ZIP/Postal Code
01757
Country
United States
Facility Name
Dr. John Fenyk
City
Chaska
State/Province
Minnesota
ZIP/Postal Code
55318
Country
United States
Facility Name
Dr. Joel Schlessinger
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Dr. AnneMarie Uliasz
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Dr. Willard Niemi
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27615
Country
United States
Facility Name
Dr. Diane Baker
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
Facility Name
Dr. John Barnes
City
Portland
State/Province
Oregon
ZIP/Postal Code
97205
Country
United States
Facility Name
Dr. Harry Penny
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Dr. Lawrence Parish
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Dr. Cynthia Strout
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Dr. Teresa Coats
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Dr. Scott J. Ashton
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Dr. Amit Pandya
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8802
Country
United States
Facility Name
Dr. Lawrence Harkless
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
Dr. Robert Shouey
City
Harrisonburg
State/Province
Virginia
ZIP/Postal Code
22801
Country
United States
Facility Name
Novartis Investigative Site
City
Various cities
Country
Canada
Facility Name
Novartis Investigative Site
City
Various cities
Country
Iceland

12. IPD Sharing Statement

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

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