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

NCT ID: NCT03129321

Last Updated: 2022-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 876 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-15
• Study Completion Date: 2016-11-17

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.

Conditions

Tinea Pedis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Test

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

Group Type: EXPERIMENTAL

Econazole Nitrate Cream, 1%

Intervention Type: DRUG

Reference Standard

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

Group Type: ACTIVE_COMPARATOR

Econazole Nitrate Cream, 1%

Intervention Type: DRUG

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Econazole Nitrate Cream, 1%

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DPT Laboratories, Ltd.

INDUSTRY

Sponsor Role: collaborator

Mylan Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

71532902

Identifier Type: -

Identifier Source: org_study_id