NCT00443898

Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail

A Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of Topical Terbinafine Hydrogen Chloride (HCl) Formulation for 24 or 48 Weeks of Treatment in Patients With Mild to Moderate Toenail Onychomycosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 518 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DRUG	terbinafine	Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 48 weeks
DRUG	Placebo	vehicle (placebo) applied once daily for 48 weeks
DRUG	terbinafine	Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 24 weeks
DRUG	Placebo	vehicle (placebo) applied once daily for 24 weeks

Timeline

• Start date: 2006-12-01
• Primary completion: 2008-06-01
• First posted: 2007-03-07
• Last updated: 2012-05-03
• Results posted: 2011-04-20

Locations

22 sites across 3 countries: United States, Canada, Iceland