Status:
COMPLETED
Iontophoretic Application of Terbinafine Gel to the Large Toe Nail
Lead Sponsor:
Transport Pharmaceuticals
Conditions:
Onychomycosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 terbinaf...
Eligibility Criteria
Inclusion
- Male and female volunteers between 18 and 75 years of age, inclusive.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00768768
Start Date
October 1 2008
End Date
March 1 2009
Last Update
March 12 2009
Active Locations (1)
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1
Cetero Research
Fargo, North Dakota, United States, 58104