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

Mylan

Status and phase: Completed; Phase 3

Conditions: Tinea Pedis

Treatments: Drug: Placebo; Drug: Econazole Nitrate Cream, 1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT03129321

71532902

Details and patient eligibility

About

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.

Enrollment: 876 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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876 participants in 3 patient groups, including a placebo group

Test

Experimental group

Description:

Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days

Treatment:

Drug: Econazole Nitrate Cream, 1%

Reference Standard

Active Comparator group

Description:

Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days

Treatment:

Drug: Econazole Nitrate Cream, 1%

Placebo

Placebo Comparator group

Description:

Placebo Cream, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days

Treatment:

Drug: Placebo