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 subjects with distal subungual tinea unguium of the toenails (onychomycosis). 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
75
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
Quanitative improvement in toenail appearance.
Assessment of dermatophyte culture and KOH examination.
Frequency and severity of adverse events.
Time to achieve 90% and 100% clearance of fungus from nail.
Assessment of treatment success.
Assessment of mycological success.
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