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
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
Taro Pharmaceuticals USA
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
Merz Pharmaceuticals, LLC
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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