Conditions: Tinea Pedis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 876
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days arm 2: Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days arm 3: Placebo Cream, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days

Interventions: intervention 1: Econazole Nitrate Cream, 1% intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: