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.
Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis
Completed
Taro Pharmaceuticals USA
Phase 1
2012-05-01
The objective of this study is to evaluate the efficacy and safety of the test formulation of
Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.) as compared to the already marketed
formulation Naftin® (Naftifine HCl) 1% Cream (Merz Pharmaceuticals) and placebo in patients
with tinea pedis and to show the superiority of the active treatments over placebo when dosed
once a day for 28 days.
Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis
Completed
Merz North America, Inc.
Phase 4
2012-10-01
This study is being done to see how the body is affected when a study drug is applied to both
feet if the subject has athlete's foot or to both feet and the groin area if the subject has
both athlete's foot and jock itch. Safety of the drug and how well the drug works will also
be measured.
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