Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
75 participants
INTERVENTIONAL
2005-09-30
Brief Summary
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The formulation used as the vehicle for the active agents has been shown in earlier studies to facilitate the penetration of the active agent through fungally-infected nails. This study will examine dose-response and agent differences in terms of efficacy and safety.
Once the subject has qualified for the study, he/she will be randomly assigned to one of five study groups, dispensed appropriate study medication and instructed to apply one drop to the great toe designated for study.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Interventions
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Organogel of naftifine, 2%
Organogel of terbinafine, 2%
Organogel of naftifine, 6%
Organogel of terbinafine, 6%
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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MediQuest Therapeutics
INDUSTRY
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Genova Clinical Research, Inc.
Tucson, Arizona, United States
Greater Miami Skin and Laser Center
Miami Beach, Florida, United States
Washington University
St Louis, Missouri, United States
Northwest Cutaneous research
Portland, Oregon, United States
Countries
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Other Identifiers
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MQT-05-001
Identifier Type: -
Identifier Source: org_study_id