Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
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.
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
- NCT00443898
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 518 participants
Conditions and interventions
Conditions
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
- Dec 2006 (Type not available)
- Primary completion
- Jun 2008 (Actual)
- Completion
- Not listed
- Last update posted
- May 3, 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 3, 2012 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00443898 live on ClinicalTrials.gov.