Status:
COMPLETED
Topical Gel Anti-Fungal Agent for Tinea Unguium
Lead Sponsor:
MediQuest Therapeutics
Conditions:
Onychomycosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to compare, in a controlled fashion, the response to two anti-fungal agents, naftifine or terbinafine, with vehicle in novel topical gel formulations in the treatment of s...
Eligibility Criteria
Inclusion
- clinical diagnosis of distal subungual tinuea unguium of one great toenail.
- between 20 - 65% infected area for target nail
- 2 mm of clear nail proximally on target nail
- positive dermatophyte culture and positive KOH test
- able to sign informed consent
- understand requirements of study
- females must be post-menopausal or agree to use approved contraceptives throughout the study
Exclusion
- patients with nails infected with organisms other than dermatophytes
- patients with proximal subungual tinea unguium
- patients with spikes of disease extending to nail matrix
- patients with more than 5 infected nails
- patients with confounding problems/ abnormalities of target nail
- patients with screening lab values more than 20% of normal
- patients with known hypersensitivity to test material components
- patients requiring systemic medications that may interfere with study
- patients with a poor history of compliance with study requirements
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00253305
Start Date
September 1 2005
Last Update
May 30 2007
Active Locations (5)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Genova Clinical Research, Inc.
Tucson, Arizona, United States, 85741
3
Greater Miami Skin and Laser Center
Miami Beach, Florida, United States, 33140
4
Washington University
St Louis, Missouri, United States, 63110