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

• ClinicalTrials.gov Identifier: NCT03129321
• Recruitment Status: Completed
• First Posted: April 26, 2017
• Results First Posted: August 2, 2018
• Last Update Posted: March 7, 2022
• Sponsor: Mylan Inc.
• Collaborator: DPT Laboratories, Ltd.
• Information provided by (Responsible Party): Viatris Inc. ( Mylan Inc. )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Tinea Pedis	Drug: Econazole Nitrate Cream, 1%; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 876 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Clinical Study to Evaluate the Therapeutic Equivalence and Safety of Econazole Nitrate Cream, 1% (Renaissance Pharma, Inc.) to Econazole Nitrate Cream, 1% (Perrigo New York Inc.) in Tinea Pedis
• Actual Study Start Date: March 15, 2016
• Actual Primary Completion Date: November 17, 2016
• Actual Study Completion Date: November 17, 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Test; Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days	Drug: Econazole Nitrate Cream, 1%
Active Comparator: Reference Standard; Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days	Drug: Econazole Nitrate Cream, 1%
Placebo Comparator: Placebo; Placebo Cream, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days	Drug: Placebo

Outcome Measures

Primary Outcome Measures :

1. Proportion of Patients in Each Active Treatment Group Who Are Considered a Therapeutic Cure [ Time Frame: 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
2. Proportion of Patients in Each Treatment Group Who Are Considered a Therapeutic Cure [ Time Frame: 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 :

1. 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) [ Time Frame: 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
2. Proportion of Patients in Each Active Treatment Group Who Are Considered a Mycological Cure [ Time Frame: 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
3. 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) [ Time Frame: 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
4. Proportion of Patients in Each Treatment Group Who Are Considered a Mycological Cure [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Mylan Inc.
• ClinicalTrials.gov Identifier: NCT03129321
• Other Study ID Numbers: 71532902
• First Posted: April 26, 2017
• Results First Posted: August 2, 2018
• Last Update Posted: March 7, 2022
• Last Verified: March 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Tinea; Tinea Pedis; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Foot Dermatoses; Foot Diseases; Pruritus; Skin Manifestations; Econazole; Antifungal Agents; Anti-Infective Agents; 14-alpha Demethylase Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Steroid Synthesis Inhibitors; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs