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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00459537
First received: April 10, 2007
Last updated: May 3, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Onychomycosis
Drug: terbinafine hydrogen chloride
Drug: amorolfine nail lacquer
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 1029
Study Start Date: March 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Terbinafine
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.
Drug: terbinafine hydrogen chloride
10 % terbinafine hydrogen chloride (HCL)
Other Name: Lamisil
Active Comparator: Amorolfine
5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
Drug: amorolfine nail lacquer
5 % amorolfine nail lacquer

  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)
  • 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00459537

Locations
Finland
Novartis Investigative Site
Various Cities, Finland
France
Novartis Investigative Site
Various Cities, France
Germany
Novartis Investigative Site
Various Cities, Germany
Hungary
Novartis Investigative Site
Various Cities, Hungary
Iceland
Novartis Investigative Site
Various Cities, Iceland
Norway
Novartis Investigative Site
Various Cities, Norway
Poland
Novartis Investigative Site
Various Cities, Poland
Russian Federation
Novartis Investigative Site
Various Cities, Russian Federation
Spain
Novartis Investigative Site
Various Cities, Spain
Turkey
Novartis Investigative Site
Various Cities, Turkey
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00459537     History of Changes
Other Study ID Numbers: CSFO327N2303
Study First Received: April 10, 2007
Results First Received: January 19, 2011
Last Updated: May 3, 2011
Health Authority: Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: Országos Gyógyszerészeti Intézet
Iceland: Icelandic Medicines Control Agency
Norway: Norwegian Medicines Agency
Poland: Central Register of Clinical Trials
Russia: Ministry of Health of the Russian Federation
Spain: Ministry of Health
Turkey: T.C. Sağlık Bakanlığı

Keywords provided by Novartis:
Toenail fungus
Onychomycosis
Nail fungus
Toenail fungal infection
Tinea unguium
Dermatophytes
Foot dermatoses

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Amorolfine
Terbinafine
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014