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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: NCT00443820

Public ClinicalTrials.gov record NCT00443820. 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 Sep 3, 2026, 12:50 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00443820
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
526 participants

Conditions and interventions

Conditions

Interventions

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
May 31, 2008
Last update posted
Apr 18, 2011

2006 – 2008

United States locations

U.S. sites
20
U.S. states
18
U.S. cities
20
Facility City State ZIP Site status
Dr. Fred D. Youngswick Novato California 94945
Dr. Larry Doehring Northglenn Colorado 80234
Dr. Robert P. Dunne Melbourne Florida 32935
Dr. Mark Ling Newnan Georgia 30263
Dr. Jesse Plasencia Chicago Illinois 60632
Dr. John Mallory Overland Park Kansas 66215
Dr. Jeffrey Conrow Topeka Kansas 66606
Dr.Michael Kaye Covington Louisiana 70433
Dr. Max Weisfeld Baltimore Maryland 21214
Dr. Linda Stein-Gold Detroit Michigan 48202
Dr. Anna Glaser St Louis Missouri 63104
Dr. Richard Scher New York New York 10032
Dr. Joseph Jorrizo Winston-Salem North Carolina 27157
Dr. Anne Lucky Cincinnati Ohio 45230
Dr. Rich Phoebe Portland Oregon 97210
Dr. Patricia Westmorland Simpsonville South Carolina 29681
Dr. David Horowitz Nashville Tennessee 37203
Dr. Jay Lifshen Irving Texas 75061
Dr. Richard Pollak San Antonio Texas 78229
Dr. Patrick Agnew Virginia Beach Virginia 23464

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 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00443820, 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 Apr 18, 2011 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00443820 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →