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

NCT00459537 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1029

Last updated 2011-05-06

Study results available
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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

DRUG

terbinafine hydrogen chloride

10 % terbinafine hydrogen chloride (HCL)

DRUG

amorolfine nail lacquer

5 % amorolfine nail lacquer

Sponsors & Collaborators

Principal Investigators

  • Novartis · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • Finland
  • France
  • Germany
  • Hungary
  • Iceland
  • Norway
  • Poland
  • Russia
  • Spain
  • Turkey (Türkiye)

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00459537 on ClinicalTrials.gov