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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Onychomycosis

Intervention / Treatment
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* Drug: terbinafine hydrogen chloride
* Drug: amorolfine nail lacquer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Terbinafine<br>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<br>* 10 % terbinafine hydrogen chloride (HCL)<br>* Other names: Lamisil;|
| Active Comparator: Amorolfine<br>5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails. | Drug: amorolfine nail lacquer<br>* 5 % amorolfine nail lacquer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 52 | 
| 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. | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 52 | 
| 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 | Week 52 | 
| 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. | Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Toenail fungus, Onychomycosis, Nail fungus, Toenail fungal infection, Tinea unguium, Dermatophytes, Foot dermatoses