Onychomycosis Clinical Trial
Official title:
A Study of Skin/Nail Sensation and the Pharmacokinetics of the Uptake of Terbinafine in the Great Toe Nail and Systemically Following Treatment With the Electrokinetic Transungual System (ETS)-Terbinafine Gel in Healthy Normal Voluneteers
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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