Conditions: Onychomycosis
Keywords: Toenail fungus Onychomycosis Nail fungus Toenail fungal infection Tinea unguium Dermatophytes Foot dermatoses
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 518
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks arm 2: vehicle (placebo) applied once daily for 48 weeks arm 3: Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks arm 4: vehicle (placebo) applied once daily for 24 weeks

Interventions: intervention 1: terbinafine intervention 2: Placebo intervention 3: terbinafine intervention 4: Placebo
Intervention descriptions: intervention 1: Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 48 weeks intervention 2: vehicle (placebo) applied once daily for 48 weeks intervention 3: Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 24 weeks intervention 4: vehicle (placebo) applied once daily for 24 weeks

Protocol document: