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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Iontophoretic Dose Level 1 |
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| 2 | Active Comparator | Iontophoretic Dose Level 2 |
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| 3 | Active Comparator | Iontophoretic Dose Level 3 |
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| 4 | Active Comparator | Iontophoretic Dose Level 4 |
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| 5 | Active Comparator | Iontophoretic Dose Level 5 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrokinetic Transungual System (ETS) - Terbinafine Gel | Other | Iontophoresis in conjunction with a terbinafine gel Drug Dose: ETS drug cartridge loaded with approximately 20 mg - 35 mg of terbinafine in the gel formulation, with the load depending on the size of the toenail to be treated. Two different drug applicators to be tested on each subject Single treatment on each toenail; one treatment with one drug applicator design, the second treatment with the alternative drug applicator design Iontophoretic Dose: 3 mA-min as 0.3 mA for 10 min |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the skin/nail sensation noted by subjects during and following iontophoretic application of terbinafine gel to the great toenail | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the uptake into the nail of the great toe and the systemic uptake and pharmacokinetics of terbinafine following a single iontophoretic application of terbinafine gel | 12 weeks and 24 hours, respectively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig Sprenger, MD | Cetero Research, San Antonio | Principal Investigator |
| Eric M Morrel, PhD | Transport Pharmaceuticals, Inc. | Study Director |
| Philip M Friden, PhD | Transport Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cetero Research | Fargo | North Dakota | 58104 | United States |
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| ID | Term |
|---|---|
| D014009 | Onychomycosis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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|
| ETS-Terbinafine Gel | Other | Iontophoresis in conjunction with a terbinafine gel Drug Dose: ETS drug cartridge loaded with approximately 20 mg - 35 mg of terbinafine in the gel formulation, with the load depending on the size of the toenail to be treated. Two different drug applicators to be tested on each subject Single treatment on each toenail; one treatment with one drug applicator design, the second treatment with the alternative drug applicator design Iontophoretic Dose: 6 mA-min as 0.5 mA for 12 min |
|
| ETS-Terbinafine Gel | Other | Iontophoresis in conjunction with a terbinafine gel Drug Dose: ETS drug cartridge loaded with approximately 20 mg - 35 mg of terbinafine in the gel formulation, with the load depending on the size of the toenail to be treated. Two different drug applicators to be tested on each subject Single treatment on each toenail; one treatment with one drug applicator design, the second treatment with the alternative drug applicator design Iontophoretic Dose: 6 mA-min as 0.3 mA for 20 min |
|
| ETS-Terbinafine Gel | Other | Iontophoresis in conjunction with a terbinafine gel Drug Dose: ETS drug cartridge loaded with approximately 20 mg - 35 mg of terbinafine in the gel formulation, with the load depending on the size of the toenail to be treated. Two different drug applicators to be tested on each subject Single treatment on each toenail; one treatment with one drug applicator design, the second treatment with the alternative drug applicator design Iontophoretic Dose: 10 mA-min as 0.5 mA for 20 min |
|
| ETS-Terbinafine Gel | Other | Iontophoresis in conjunction with a terbinafine gel Drug Dose: ETS drug cartridge loaded with approximately 20 mg - 35 mg of terbinafine in the gel formulation, with the load depending on the size of the toenail to be treated. Two different drug applicators to be tested on each subject Single treatment on each toenail; one treatment with one drug applicator design, the second treatment with the alternative drug applicator design Iontophoretic Dose: 15 mA-min as 0.5 mA for 30 min |
|
| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |