Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
This study is designed to assess the efficacy, safety and tolerability of a topical
 formulation of terbinafine solution applied daily in patients with toenail fungus. This trial
 will study patients with mild to moderate toenail fungus disease of the big toenail and their
 responses to two treatment durations, 24 or 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)

 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 terbinifine 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

 -  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