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Completed

NCT Number: NCT00768768

Iontophoretic Application of Terbinafine Gel to the Large Toe Nail

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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Key information

Conditions

Onychomycosis Bacterial Infections and Mycoses Dermatomycoses Infections Mycoses Nail Diseases Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases Tinea

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cetero Research

Fargo, North Dakota, 58104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Transport Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 8, 2008
Registry last updated
Mar 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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