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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: Completed Phase 1 study, sponsored by Transport Pharmaceuticals.

NCT00768768 is a Phase 1 study that has completed, run by Transport Pharmaceuticals. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 40 participants
Start Date 2008-10
Est. Completion 2009-03
Phase Phase 1
Transport Pharmaceuticals

3 total trials

What the finished NCT00768768 record still lists

NCT00768768 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).

The record links to 0 conditions, and to 2 interventions - of which Electrokinetic Transungual System (ETS) - Terbinafine Gel is the first listed.

NCT00768768 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00768768's enrollment target sits among peer trials

40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT00768768, the US trial registry maintained by the National Library of Medicine. NCT00768768 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.