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

Trial end date:
Target enrollment:
Participant gender:
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.
Phase 3
Accepts Healthy Volunteers?
Lead Sponsor:
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

- 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