Conditions: Onychomycosis
Keywords: Toenail fungus Onychomycosis Nail fungus Toenail fungal infection Tinea unguium Dermatophytes Foot dermatoses
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1029
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: 10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry. arm 2: 5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.

Interventions: intervention 1: terbinafine hydrogen chloride intervention 2: amorolfine nail lacquer
Intervention descriptions: intervention 1: 10 % terbinafine hydrogen chloride (HCL) intervention 2: 5 % amorolfine nail lacquer

Protocol document: