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

Phase 3

Completed

Interventions: Drug: amorolfine nail lacquer
Drug: terbinafine hydrogen chloride

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Amorolfine	amorolfine nail lacquer	5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
Terbinafine	terbinafine hydrogen chloride	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks	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.	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Mycological Cure at End of Study After Treating Patients for 48 Weeks	Week 52	Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes
Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Patients for 48 Weeks.	Week 52	Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and \<= 10% residual involvement of the target toenail.
Safety and Tolerability Assessed by the Number of Participants With Adverse Events	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.