To evaluate the therapeutic equivalence of the Test formulation, econazole nitrate cream, 1% to the Reference product, econazole nitrate cream, 1% in the treatment of tinea pedis. To demonstrate the superiority of the Test and Reference (active) treatments over Placebo treatment in patients with tinea pedis. To compare the safety of Test, Reference and Placebo treatments in patients with tinea pedis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
876
Proportion of Patients in Each Active Treatment Group Who Are Considered a Therapeutic Cure
To be considered a Therapeutic Cure, the patient must have both Clinical Cure (patient's total severity score must be ≤ 2 with no individual severity score \> 1) and Mycological Cure (patient must have a negative KOH test and a negative fungal culture) of tinea pedis
Time frame: Day 42
Proportion of Patients in Each Treatment Group Who Are Considered a Therapeutic Cure
To be considered a Therapeutic Cure, the patient must have both Clinical Cure (patient's total severity score must be ≤ 2 with no individual severity score \> 1) and Mycological Cure (patient must have a negative KOH test and a negative fungal culture) of tinea pedis
Time frame: Day 42
Proportion of Patients in Each Active Treatment Group Who Are Considered a Clinical Cure (Patient's Total Severity Score Must be ≤ 2 With no Individual Severity Score > 1)
The following Clinical Signs and Symptoms of a target lesion with tinea pedis are individually rated for severity (none, mild, moderate, or severe): fissuring/cracking, erythema, maceration, scaling, pruritus, and burning/stinging
Time frame: Day 42
Proportion of Patients in Each Active Treatment Group Who Are Considered a Mycological Cure
To be considered a mycological cure the patient must have a negative KOH test and a negative fungal culture for T. rubrum, T. mentagrophytes or E. floccosum
Time frame: Day 42
Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Cure (Patient's Total Severity Score Must be ≤ 2 With no Individual Severity Score > 1)
The following Clinical Signs and Symptoms of a target lesion with tinea pedis are individually rated for severity (none, mild, moderate, or severe): fissuring/cracking, erythema, maceration, scaling, pruritus, and burning/stinging
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Time frame: Day 42
Proportion of Patients in Each Treatment Group Who Are Considered a Mycological Cure
To be considered a mycological cure the patient must have a negative KOH test and a negative fungal culture for T. rubrum, T. mentagrophytes or E. floccosum
Time frame: Day 42