Iontophoretic Application of Terbinafine Gel to the Large Toe Nail

Onychomycosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00768768
• Other study ID #: TPI-N-111
• Status: Completed
• Phase: Phase 1
• First received: October 6, 2008
• Last updated: March 10, 2009
• Start date: October 2008
• Est. completion date: March 2009

Study information

• Verified date: March 2009
• Source: Transport Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Onychomycosis

Intervention

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
• 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
• 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
• 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
• 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

Locations

Country	Name	City	State
United States	Cetero Research	Fargo	North Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Transport Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the skin/nail sensation noted by subjects during and following iontophoretic application of terbinafine gel to the great toenail		12 weeks	Yes
Secondary	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		12 weeks and 24 hours, respectively	Yes