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Iontophoretic Application of Terbinafine Gel to the Large Toe Nail

Primary Purpose

Onychomycosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Electrokinetic Transungual System (ETS) - Terbinafine Gel
ETS-Terbinafine Gel
ETS-Terbinafine Gel
ETS-Terbinafine Gel
ETS-Terbinafine Gel
Sponsored by
Transport Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onychomycosis focused on measuring iontophoresis, terbinafine, onychomycosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Cetero Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

5

Arm Description

Iontophoretic Dose Level 1

Iontophoretic Dose Level 2

Iontophoretic Dose Level 3

Iontophoretic Dose Level 4

Iontophoretic Dose Level 5

Outcomes

Primary Outcome Measures

Evaluate the skin/nail sensation noted by subjects during and following iontophoretic application of terbinafine gel to the great toenail

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

Full Information

First Posted
October 6, 2008
Last Updated
March 10, 2009
Sponsor
Transport Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00768768
Brief Title
Iontophoretic Application of Terbinafine Gel to the Large Toe Nail
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Transport Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
Keywords
iontophoresis, terbinafine, onychomycosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Iontophoretic Dose Level 1
Arm Title
2
Arm Type
Active Comparator
Arm Description
Iontophoretic Dose Level 2
Arm Title
3
Arm Type
Active Comparator
Arm Description
Iontophoretic Dose Level 3
Arm Title
4
Arm Type
Active Comparator
Arm Description
Iontophoretic Dose Level 4
Arm Title
5
Arm Type
Active Comparator
Arm Description
Iontophoretic Dose Level 5
Intervention Type
Other
Intervention Name(s)
Electrokinetic Transungual System (ETS) - Terbinafine Gel
Intervention Description
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
Intervention Name(s)
ETS-Terbinafine Gel
Intervention Description
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
Intervention Name(s)
ETS-Terbinafine Gel
Intervention Description
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
Intervention Name(s)
ETS-Terbinafine Gel
Intervention Description
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
Intervention Name(s)
ETS-Terbinafine Gel
Intervention Description
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
Primary Outcome Measure Information:
Title
Evaluate the skin/nail sensation noted by subjects during and following iontophoretic application of terbinafine gel to the great toenail
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Sprenger, MD
Organizational Affiliation
Cetero Research, San Antonio
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric M Morrel, PhD
Organizational Affiliation
Transport Pharmaceuticals, Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Philip M Friden, PhD
Organizational Affiliation
Transport Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Cetero Research
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States

12. IPD Sharing Statement

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Iontophoretic Application of Terbinafine Gel to the Large Toe Nail

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