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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00443898

Public ClinicalTrials.gov record NCT00443898. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 5:30 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID
NCT00443898
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
518 participants

Conditions and interventions

Conditions

Interventions

  • terbinafine Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
12 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 2006
Primary completion
May 31, 2008
Completion
Not listed
Last update posted
May 2, 2012

Started 2006

United States locations

U.S. sites
20
U.S. states
15
U.S. cities
19
Facility City State ZIP Site status
Dr. Boni Elewski Birmingham Alabama 35233
Dr. Stacy Smith San Diego California 92123
Dr. James Swinehart Denver Colorado 80210
Dr. David G. Armstrong North Chicago Illinois 60064
Dr. Kevin Terry Lutherville Maryland 21093
Dr. Anthony Puopolo Milford Massachusetts 01757
Dr. John Fenyk Chaska Minnesota 55318
Dr. Joel Schlessinger Omaha Nebraska 68144
Dr. AnneMarie Uliasz New York New York 10029
Dr. Willard Niemi Raleigh North Carolina 27615
Dr. Diane Baker Lake Oswego Oregon 97035
Dr. John Barnes Portland Oregon 97205
Dr. Harry Penny Altoona Pennsylvania 16602
Dr. Lawrence Parish Philadelphia Pennsylvania 19103
Dr. Cynthia Strout Mt. Pleasant South Carolina 29464
Dr. Teresa Coats Austin Texas 78705
Dr. Scott J. Ashton Dallas Texas 75243
Dr. Amit Pandya Dallas Texas 75390-8802
Dr. Lawrence Harkless San Antonio Texas 78207
Dr. Robert Shouey Harrisonburg Virginia 22801

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00443898, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 2, 2012 · Synced Jul 21, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00443898 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →