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

Phase 3

Completed

• Conditions: Tinea Pedis
• Interventions: Drug: Econazole Nitrate Cream, 1%; Drug: Placebo

• Registration Number: NCT03129321
• Lead Sponsor: Mylan Inc.

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

Not available

Study Timeline

• Study Start: 2016-03-15
• Primary Completion: 2016-11-17
• Study Completion: 2016-11-17
• Study First Submitted: 2017-04-05
• Study First Submitted QC: 2017-04-21
• Study First Posted: 2017-04-26
• Disposition First Submitted: 2017-08-03
• Disposition First Submitted QC: 2017-08-03
• Disposition First Posted: 2017-08-08
• Results First Submitted: 2018-05-18
• Results First Submitted QC: 2018-07-09
• Results First Posted: 2018-08-02
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-03
• Last Update Posted: 2022-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 876

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test	Econazole Nitrate Cream, 1%	Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days
Reference Standard	Econazole Nitrate Cream, 1%	Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days
Placebo	Placebo	Placebo Cream, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days

Primary Outcome Measures

Name	Time	Method
Proportion of Patients in Each Active Treatment Group Who Are Considered a Therapeutic Cure	Day 42	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
Proportion of Patients in Each Treatment Group Who Are Considered a Therapeutic Cure	Day 42	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

Secondary Outcome Measures

Name	Time	Method
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)	Day 42	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
Proportion of Patients in Each Active Treatment Group Who Are Considered a Mycological Cure	Day 42	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
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)	Day 42	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
Proportion of Patients in Each Treatment Group Who Are Considered a Mycological Cure	Day 42	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