Iontophoretic Application of Terbinafine Gel to the Large Toe Nail

Transport Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Onychomycosis

Treatments: Other: ETS-Terbinafine Gel; Other: Electrokinetic Transungual System (ETS) - Terbinafine Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00768768

TPI-N-111

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male and female volunteers between 18 and 75 years of age, inclusive.

Exclusion criteria

• Subjects with pacemakers or automatic implantable cardioverter/defibrillator
• Subjects with an implantable electronic device.
• Subjects with a history of diabetes.
• Subjects with a history of onychomycosis or an abnormal appearing nail on the great toe
• Subject using systemic antifungal medications within 6 months prior to study enrollment.
• Subject using prescription topical antifungal medications for toenail fungus within 3 months or other commercially available medications for toenail fungus applied directly to the toenail within 1 week prior to study enrollment.
• Subject with a history of allergic or adverse response to terbinafine or any related anti-fungal drug
• Participation in a previous clinical trial involving an investigational drug or device within 30 days prior to study enrollment.
• Subject requires chronic use of analgesics, pain medication, or non-steroidal anti-inflammatory agents (NSAIDS).
• In females of childbearing potential, a positive urine pregnancy test at screening and just prior to dosing.
• Nursing mothers.
• Subject with a history of alcoholism or drug abuse within the preceding 12 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 5 patient groups

1

Active Comparator group

Description:

Iontophoretic Dose Level 1

Treatment:

Other: Electrokinetic Transungual System (ETS) - Terbinafine Gel

2

Active Comparator group

Description:

Iontophoretic Dose Level 2

Treatment:

Other: ETS-Terbinafine Gel

Other: ETS-Terbinafine Gel

Other: ETS-Terbinafine Gel

Other: ETS-Terbinafine Gel

3

Active Comparator group

Description:

Iontophoretic Dose Level 3

Treatment:

Other: ETS-Terbinafine Gel

Other: ETS-Terbinafine Gel

Other: ETS-Terbinafine Gel

Other: ETS-Terbinafine Gel

4

Active Comparator group

Description:

Iontophoretic Dose Level 4

Treatment:

Other: ETS-Terbinafine Gel

Other: ETS-Terbinafine Gel

Other: ETS-Terbinafine Gel

Other: ETS-Terbinafine Gel

5

Active Comparator group

Description:

Iontophoretic Dose Level 5

Treatment:

Other: ETS-Terbinafine Gel

Other: ETS-Terbinafine Gel

Other: ETS-Terbinafine Gel

Other: ETS-Terbinafine Gel