Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride Versus 5% Amorolfine Nail Lacquer in Patients With Mild to Moderate Toenail Onychomycosis
Condition: Onychomycosis
MeSH terms: Onychomycosis
Intervention: terbinafine hydrogen chloride; amorolfine nail lacquer
Intervention description: 10 % terbinafine hydrogen chloride (HCL); 5 % amorolfine nail lacquer
Intervention MeSH terms: Terbinafine; Amorolfine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1029.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Toenail fungus; Onychomycosis; Nail fungus; Toenail fungal infection; Tinea unguium; Dermatophytes; Foot dermatoses

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.
    

Eligibility 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