Efficacy Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail

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

- 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