Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis
Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis
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.
Inclusion Criteria:

 -  Healthy male or non-pregnant, non-lactating female ≥ 18 years of age.

 -  Clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or
 predominantly interdigital, but may extend to other areas of the foot (the
 non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea
 pedis moccasin).

 -  Provisionally confirmed at baseline by a positive potassium hydroxide (KOH) wet mount
 preparation

 -  Total score ≥ 4 for the clinical signs and symptoms of tinea pedis in the target area.
 In addition the target area must have a minimum score of at least 2 for erythema and a
 minimum score of at least 2 for either pruritus or scaling.

 Exclusion Criteria:

 -  Presence of any other infection of the foot or other disease process that, in the
 Investigator's opinion, may interfere with the evaluation of the patient's tinea pedis

 -  History of or current psoriasis, Lichen planus or contact dermatitis involving the
 feet within the previous 12 months.

 -  Past history of dermatophyte infections with a lack of response to antifungal therapy

 -  Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface or
 onychomycosis involving ≥ 20% of the area of either great toenail and/or involving
 more than five toenails in total or other concurrent dermatophytoses (e.g., tinea
 cruris) and any other skin disease to an extent that, in the opinion of the
 investigator, might interfere with the evaluation of tinea pedis or study results