Iontophoretic Application of Terbinafine Gel to the Large Toe Nail
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 1

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.
    


Intervention name(s): Electrokinetic Transungual System (ETS) - Terbinafine Gel; ETS-Terbinafine Gel; ETS-Terbinafine Gel; ETS-Terbinafine Gel; ETS-Terbinafine Gel
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): 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; 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; 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; 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; 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 MeSH terms: Terbinafine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: iontophoresis; terbinafine; onychomycosis