NCT00459537

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

A Randomized, Open-label, Active-controlled, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride (HCl) Formulation Versus 5% Amorolfine Nail Lacquer for 48 Weeks of Treatment in Patients With Mild to Moderate Toenail Onychomycosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,029 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DRUG	terbinafine hydrogen chloride	10 % terbinafine hydrogen chloride (HCL)
DRUG	amorolfine nail lacquer	5 % amorolfine nail lacquer

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2007-04-12
• Last updated: 2011-05-06
• Results posted: 2011-04-20

Locations

10 sites across 10 countries: Finland, France, Germany, Hungary, Iceland, Norway, Poland, Russia, Spain, Turkey (Türkiye)