drugset / Trial / NCT00459537

Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride Versus 5% Amorolfine Nail Lacquer in Patients With Mild to Moderate Toenail Onychomycosis

NCT00459537

Phase 3 Completed 1029 enrolled Novartis
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2007-03
Primary completion
2009-01
Completion
2009-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amorolfine Small molecule 5 % Topical
Subject Terbinafine Small molecule 10 % Topical

Indications