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NCT00443820 · ClinicalTrials.gov registry record · Phase 3
Efficacy Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 526
- Enrollment target
NCT00443820: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00443820 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 526 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00443820, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 526 participants
- Enrollment target
Study 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.
Primary Outcome
Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.
Interventions
- DRUG Placebo
- DRUG terbinafine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 526 participants |
| Start Date | 2006-12 |
| Est. Completion | 2008-06 |
| Phase | Phase 3 |
What the finished NCT00443820 record still lists
NCT00443820 is an interventional study that assigns participants to a tested intervention. The registered 526 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00443820 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00443820 about?
NCT00443820 is a clinical study titled "Efficacy Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail". 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 d...
What is the current status of trial NCT00443820?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 526 participants. The study started on 2006-12. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00443820?
The interventions under investigation include: Placebo (DRUG), terbinafine (DRUG).
Who is sponsoring clinical trial NCT00443820?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00443820's enrollment target sits among peer trials
526 715th of 2000 higher than 1,286 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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