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