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NCT00768768 · ClinicalTrials.gov registry record · Phase 1
Iontophoretic Application of Terbinafine Gel to the Large Toe Nail
A Phase 1 study, sponsored by Transport Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT00768768 is a Phase 1 study that has completed, run by Transport Pharmaceuticals. The registered enrollment target is 40 participants.
The verdict
NCT00768768, a Phase 1 study, has completed, sponsored by Transport Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
Terbinafine is recognized as one of the most effective drugs for the treatment of toe nail fungus (onychomycosis). This trial will be the first test of a new device to improve the delivery of terbinafine directly to the toe nail. The device uses a low level of electric current, iontophoresis, to "push" the terbinafine into the nail. The study will involve a single application of terbinafine, in a gel form, with the iontophoretic device. The treatment will be applied to the surface of both large toenails of healthy subjects. Subjects will be asked to report any sensations in the nail or surrounding skin experienced during or after treatment. Samples from the edge of the treated toe nail will be taken at 2-4 week intervals to measure how much terbinafine was delivered to the nails, and blood samples will be taken for the first 24 hours after treatment to determine how much, if any, terbinafine was absorbed into the subjects's body. Observations will also be made of the treated toes to look for any irritation of the surrounding skin due to the treatment.
Interventions
- OTHER Electrokinetic Transungual System (ETS) - Terbinafine Gel
- OTHER ETS-Terbinafine Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2008-10 |
| Est. Completion | 2009-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00768768
The ClinicalTrials.gov registry entry for NCT00768768 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Transport Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Electrokinetic Transungual System (ETS) - Terbinafine Gel is the first listed.
NCT00768768 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00768768 about?
NCT00768768 is a clinical study titled "Iontophoretic Application of Terbinafine Gel to the Large Toe Nail". Terbinafine is recognized as one of the most effective drugs for the treatment of toe nail fungus (onychomycosis). This trial will be the first test of a new device to improve the delivery of terbinafine directly to the toe nail. The device uses a low level of electric current, iontophoresis, to "pu...
What is the current status of trial NCT00768768?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2008-10. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00768768?
The interventions under investigation include: Electrokinetic Transungual System (ETS) - Terbinafine Gel (OTHER), ETS-Terbinafine Gel (OTHER).
Who is sponsoring clinical trial NCT00768768?
This trial is sponsored by Transport Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
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