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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 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

Sites / Locations

  • Dr. Fred D. Youngswick
  • Dr. Larry Doehring
  • Dr. Robert P. Dunne
  • Dr. Mark Ling
  • Dr. Jesse Plasencia
  • Dr. John Mallory
  • Dr. Jeffrey Conrow
  • Dr.Michael Kaye
  • Dr. Max Weisfeld
  • Dr. Linda Stein-Gold
  • Dr. Anna Glaser
  • Dr. Richard Scher
  • Dr. Joseph Jorrizo
  • Dr. Anne Lucky
  • Dr. Rich Phoebe
  • Dr. Patricia Westmorland
  • Dr. David Horowitz
  • Dr. Jay Lifshen
  • Dr. Richard Pollak
  • Dr. Patrick Agnew
  • Novartis Investigative Site
  • Novartis
  • 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

Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks

Vehicle (placebo) for 48 weeks

Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks

Vehicle (placebo) for 24 weeks

Outcomes

Primary Outcome Measures

Efficacy Assessed by the Percentage of Participants With Complete Cure 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.

Secondary Outcome Measures

Efficacy Assessed by the Percentage of Participants With Mycological Cure at the End of Study After Treating Participants for 24 or 48 Weeks
Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes.
Efficacy Assessed by the Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Participants 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: If mycological cure (negative KOH and negative culture for dermatophytes) and = 10% residual involvement of the target toenail "No" if otherwise
Safety and Tolerability Assessed by the Number of Participants With Adverse Events
Safety and tolerability data as assessed by the number of participants with Adverse Events (AE), Serious Adverse Events, Drug discontinuation due to an AE and death. Additional details can be found in the Adverse Event Section.

Full Information

First Posted
March 2, 2007
Last Updated
March 22, 2011
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00443820
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
March 2011
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

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
526 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Vehicle (placebo) for 48 weeks
Arm Title
3
Arm Type
Experimental
Arm Description
Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Vehicle (placebo) for 24 weeks
Intervention Type
Drug
Intervention Name(s)
terbinafine
Other Intervention Name(s)
Lamisil
Intervention Description
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) once daily for 48 weeks
Intervention Type
Drug
Intervention Name(s)
terbinafine
Other Intervention Name(s)
Lamisil
Intervention Description
Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis once daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Vehicle (placebo) once daily for 24 weeks
Primary Outcome Measure Information:
Title
Efficacy Assessed by the Percentage of Participants With Complete Cure 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.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Efficacy Assessed by the Percentage of Participants With Mycological Cure at the End of Study After Treating Participants for 24 or 48 Weeks
Description
Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes.
Time Frame
52 weeks
Title
Efficacy Assessed by the Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Participants 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: 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
Safety and Tolerability Assessed by the Number of Participants With Adverse Events
Description
Safety and tolerability data as assessed by the number of participants with Adverse Events (AE), Serious Adverse Events, Drug discontinuation due to an AE and death. Additional details can be found in the Adverse Event Section.
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 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
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. Fred D. Youngswick
City
Novato
State/Province
California
ZIP/Postal Code
94945
Country
United States
Facility Name
Dr. Larry Doehring
City
Northglenn
State/Province
Colorado
ZIP/Postal Code
80234
Country
United States
Facility Name
Dr. Robert P. Dunne
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32935
Country
United States
Facility Name
Dr. Mark Ling
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Dr. Jesse Plasencia
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60632
Country
United States
Facility Name
Dr. John Mallory
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Dr. Jeffrey Conrow
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Dr.Michael Kaye
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Dr. Max Weisfeld
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21214
Country
United States
Facility Name
Dr. Linda Stein-Gold
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Dr. Anna Glaser
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Dr. Richard Scher
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Dr. Joseph Jorrizo
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Dr. Anne Lucky
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45230
Country
United States
Facility Name
Dr. Rich Phoebe
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Dr. Patricia Westmorland
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
Dr. David Horowitz
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Dr. Jay Lifshen
City
Irving,
State/Province
Texas
ZIP/Postal Code
75061
Country
United States
Facility Name
Dr. Richard Pollak
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Dr. Patrick Agnew
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23464
Country
United States
Facility Name
Novartis Investigative Site
City
Various Cities
Country
France
Facility Name
Novartis
City
Investigative Site
Country
Germany
Facility Name
Novartis Investigative Site
City
Various cities
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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