Iontophoretic Application of Terbinafine Gel to the Large Toe Nail - Full Text View

Sponsored by:	Transport Pharmaceuticals
Information provided by:	Transport Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00768768

Purpose

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.

Condition	Intervention	Phase
Onychomycosis	Other: Electrokinetic Transungual System (ETS) - Terbinafine Gel Other: ETS-Terbinafine Gel	Phase I

Drug Information available for: Terbinafine Terbinafine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
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

Further study details as provided by Transport Pharmaceuticals:

Primary Outcome Measures:

Evaluate the skin/nail sensation noted by subjects during and following iontophoretic application of terbinafine gel to the great toenail [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 [ Time Frame: 12 weeks and 24 hours, respectively ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	October 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Iontophoretic Dose Level 1	Other: 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
2: Active Comparator Iontophoretic Dose Level 2	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
3: Active Comparator Iontophoretic Dose Level 3	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
4: Active Comparator Iontophoretic Dose Level 4	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
5: Active Comparator Iontophoretic Dose Level 5	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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768768

Locations

United States, North Dakota
Cetero Research
Fargo, North Dakota, United States, 58104

Sponsors and Collaborators

Transport Pharmaceuticals

Investigators

Principal Investigator:	Craig Sprenger, MD	Cetero Research
Study Director:	Eric M Morrel, PhD	Transport Pharmaceuticals, Inc.
Study Director:	Philip M Friden, PhD	Transport Pharmaceuticals, Inc.

More Information

Transport Pharmaceuticals, Inc. Website This link exits the ClinicalTrials.gov site

Responsible Party:	Cetero Research ( Craig Sprenger, MD )
Study ID Numbers:	TPI-N-111
Study First Received:	October 6, 2008
Last Updated:	November 3, 2008
ClinicalTrials.gov Identifier:	NCT00768768
Health Authority:	United States: Food and Drug Administration

Keywords provided by Transport Pharmaceuticals:

iontophoresis
terbinafine
onychomycosis

Study placed in the following topic categories:

Mycoses
Skin Diseases, Infectious
Onychomycosis
Skin Diseases
Clotrimazole
Miconazole

Tioconazole
Healthy
Tinea
Terbinafine
Dermatomycoses

Additional relevant MeSH terms:

Anti-Infective Agents
Nail Diseases
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Antifungal Agents
Enzyme Inhibitors
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009