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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

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ClinicalTrials.gov Identifier: NCT00459537
Recruitment Status : Completed
First Posted : April 12, 2007
Results First Posted : April 20, 2011
Last Update Posted : May 6, 2011
Sponsor:
Information provided by:
Novartis

Tracking Information
First Submitted Date  ICMJE April 10, 2007
First Posted Date  ICMJE April 12, 2007
Results First Submitted Date  ICMJE January 19, 2011
Results First Posted Date  ICMJE April 20, 2011
Last Update Posted Date May 6, 2011
Study Start Date  ICMJE March 2007
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2011)
  • Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks [ Time Frame: Week 52 ]
    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 ]
    Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.
Original Primary Outcome Measures  ICMJE
 (submitted: April 11, 2007)
Efficacy assessed by complete cure rate (negative culture, negative KOH microscopy and no residual disease involvement) at the end of study (week 52) after treating patients for 48 weeks.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2011)
  • Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Patients for 48 Weeks. [ Time Frame: Week 52 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2007)
  • Efficacy assessed by mycological cure (negative culture and negative KOH microscopy) and clinical efficacy (less than 10% residual disease involvement) at the end of study after treating patients for 48 weeks.
  • Safety and tolerability assessed by adverse events and laboratory values.
  • Explore patient's satisfaction with medication using a validated questionnaire.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Onychomycosis
Intervention  ICMJE
  • Drug: terbinafine hydrogen chloride
    10 % terbinafine hydrogen chloride (HCL)
    Other Name: Lamisil
  • Drug: amorolfine nail lacquer
    5 % amorolfine nail lacquer
Study Arms  ICMJE
  • 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.
    Intervention: Drug: terbinafine hydrogen chloride
  • Active Comparator: Amorolfine
    5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
    Intervention: Drug: amorolfine nail lacquer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2009)
1029
Original Enrollment  ICMJE
 (submitted: April 11, 2007)
926
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland,   France,   Germany,   Hungary,   Iceland,   Norway,   Poland,   Russian Federation,   Spain,   Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00459537
Other Study ID Numbers  ICMJE CSFO327N2303
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party External Affairs, Novartis
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Novartis
PRS Account Novartis
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP