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
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 |
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.
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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Cetero Research | Fargo | North Dakota |
Lead Sponsor | Collaborator |
---|---|
Transport Pharmaceuticals |
United States,
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 |
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