Iontophoretic Application of Terbinafine Gel to the Large Toe Nail

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

October 31, 2008

Primary Completion Date

January 31, 2009

Study Completion Date

March 31, 2009

Conditions
Onychomycosis
Interventions
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"

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"

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"

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"

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"

Trial Locations (1)

58104

Cetero Research, Fargo

Sponsors
All Listed Sponsors
lead

Transport Pharmaceuticals

INDUSTRY

NCT00768768 - Iontophoretic Application of Terbinafine Gel to the Large Toe Nail | Biotech Hunter | Biotech Hunter