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Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride Versus 5% Amorolfine Nail Lacquer in Patients With Mild to Moderate Toenail Onychomycosis

Primary Purpose

Onychomycosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
terbinafine hydrogen chloride
amorolfine nail lacquer
Sponsored by
Novartis
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)
  • The target toenail area must have at least 25% to no more than 75% disease involvement without spikes.

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
  • Patients with the target toenail involving the matrix (lunula) or having less than 2mm clear (unaffected) nail plate length beyond the proximal fold.
  • Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail.
  • 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

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Terbinafine

Amorolfine

Arm Description

10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.

5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.

Outcomes

Primary Outcome Measures

Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks
Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.
Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks.
Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.

Secondary Outcome Measures

Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Patients for 48 Weeks.
Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and <= 10% residual involvement of the target toenail.
Percentage of Participants With Mycological Cure at End of Study After Treating Patients for 48 Weeks
Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes
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 or SAE and death. Additional details can be found in the Adverse Event Section.

Full Information

First Posted
April 10, 2007
Last Updated
May 3, 2011
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00459537
Brief Title
Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride Versus 5% Amorolfine Nail Lacquer in Patients With Mild to Moderate Toenail Onychomycosis
Official Title
A Randomized, Open-label, Active-controlled, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride (HCl) Formulation Versus 5% Amorolfine Nail Lacquer for 48 Weeks of Treatment in Patients With Mild to Moderate Toenail Onychomycosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

5. Study Description

Brief Summary
This study will evaluate the efficacy, safety and tolerability of topical 10% terbinafine hydrogen chloride applied daily versus 5% amorolfine nail lacquer applied twice a week in patients with mild to moderate toenail onychomycosis, for a total treatment duration of 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
None (Open Label)
Allocation
Randomized
Enrollment
1029 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Terbinafine
Arm Type
Experimental
Arm Description
10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
Arm Title
Amorolfine
Arm Type
Active Comparator
Arm Description
5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
Intervention Type
Drug
Intervention Name(s)
terbinafine hydrogen chloride
Other Intervention Name(s)
Lamisil
Intervention Description
10 % terbinafine hydrogen chloride (HCL)
Intervention Type
Drug
Intervention Name(s)
amorolfine nail lacquer
Intervention Description
5 % amorolfine nail lacquer
Primary Outcome Measure Information:
Title
Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks
Description
Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.
Time Frame
Week 52
Title
Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks.
Description
Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Patients for 48 Weeks.
Description
Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and <= 10% residual involvement of the target toenail.
Time Frame
Week 52
Title
Percentage of Participants With Mycological Cure at End of Study After Treating Patients for 48 Weeks
Description
Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes
Time Frame
Week 52
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 or SAE and death. Additional details can be found in the Adverse Event Section.
Time Frame
Week 52

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) The target toenail area must have at least 25% to no more than 75% disease involvement without spikes. 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 Patients with the target toenail involving the matrix (lunula) or having less than 2mm clear (unaffected) nail plate length beyond the proximal fold. Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail. 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
Organizational Affiliation
Novartis
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Various Cities
Country
Finland
Facility Name
Novartis Investigative Site
City
Various Cities
Country
France
Facility Name
Novartis Investigative Site
City
Various Cities
Country
Germany
Facility Name
Novartis Investigative Site
City
Various Cities
Country
Hungary
Facility Name
Novartis Investigative Site
City
Various Cities
Country
Iceland
Facility Name
Novartis Investigative Site
City
Various Cities
Country
Norway
Facility Name
Novartis Investigative Site
City
Various Cities
Country
Poland
Facility Name
Novartis Investigative Site
City
Various Cities
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Various Cities
Country
Spain
Facility Name
Novartis Investigative Site
City
Various Cities
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride Versus 5% Amorolfine Nail Lacquer in Patients With Mild to Moderate Toenail Onychomycosis

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