Iontophoretic Application of Terbinafine Gel to the Large Toe Nail

NCT ID: NCT00768768

Last Updated: 2009-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-03-31

Brief 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.

Conditions

Onychomycosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Iontophoretic Dose Level 1

Group Type: ACTIVE_COMPARATOR

Electrokinetic Transungual System (ETS) - Terbinafine Gel

Intervention Type: 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

2

Iontophoretic Dose Level 2

Group Type: ACTIVE_COMPARATOR

ETS-Terbinafine Gel

Intervention Type: 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

3

Iontophoretic Dose Level 3

Group Type: ACTIVE_COMPARATOR

ETS-Terbinafine Gel

Intervention Type: 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

4

Iontophoretic Dose Level 4

Group Type: ACTIVE_COMPARATOR

ETS-Terbinafine Gel

Intervention Type: 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

5

Iontophoretic Dose Level 5

Group Type: ACTIVE_COMPARATOR

ETS-Terbinafine Gel

Intervention Type: 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

Interventions

Electrokinetic Transungual System (ETS) - Terbinafine Gel

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

Intervention Type: OTHER

ETS-Terbinafine Gel

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

Intervention Type: OTHER

ETS-Terbinafine Gel

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

Intervention Type: OTHER

ETS-Terbinafine Gel

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

Intervention Type: OTHER

ETS-Terbinafine Gel

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Transport Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Cetero Research

Principal Investigators

Craig Sprenger, MD

Role: PRINCIPAL_INVESTIGATOR

Cetero Research, San Antonio

Eric M Morrel, PhD

Role: STUDY_DIRECTOR

Transport Pharmaceuticals, Inc.

Philip M Friden, PhD

Role: STUDY_DIRECTOR

Transport Pharmaceuticals, Inc.

Locations

Cetero Research

Fargo, North Dakota, United States

Countries

United States

Other Identifiers

TPI-N-111

Identifier Type: -

Identifier Source: org_study_id