To compare the efficacy and safety of the test formulation Naftifine Hydrochloride Gel 2% to Naftin® (Naftifine Hydrochloride) Gel 2%
The purpose of this study is to compare the efficacy and safety of the test formulation Naftifine Hydrochloride Gel 2% to Naftin® (Naftifine Hydrochloride) Gel 2% in a six week study (four weeks after the end of two week treatment) in patients with tinea pedis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,519
Naftifine Hydrochloride Gel 2% applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.
Naftin® Gel 2% applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.
Placebo Topical Gel applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.
Therapeutic cure after end of treatment
The proportion of subjects with therapeutic cure, defined as both mycological cure and clinical cure, at the test-of-cure visit conducted four weeks after the end of treatment (study day 38-46).
Time frame: Study day 38-46
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