Conditions: Onychomycosis
Keywords: Toenail fungus Onychomycosis Nail fungus Toenail fungal infection Tinea unguium Dermatophytes Foot dermatoses
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 526
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: Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks arm 2: Vehicle (placebo) for 48 weeks arm 3: Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks arm 4: Vehicle (placebo) for 24 weeks

Interventions: intervention 1: terbinafine intervention 2: Placebo intervention 3: terbinafine intervention 4: Placebo
Intervention descriptions: intervention 1: Terbinafine hydrochloride (HCl) 10 % nail solution for onychomycosis (NSO) once daily for 48 weeks intervention 2: Vehicle (placebo) once daily for 48 weeks intervention 3: Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis once daily for 24 weeks intervention 4: Vehicle (placebo) once daily for 24 weeks

Protocol document: