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

NCT03129321 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 71532902
• Study Type: interventional
• Target: 876
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Proportion of Patients in Each Active Treatment Group Who Are Considered a Therapeutic Cure

  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

  Day 42

• Proportion of Patients in Each Treatment Group Who Are Considered a Therapeutic Cure

  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

  Day 42

Secondary Outcomes (4)

• 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

• Proportion of Patients in Each Active Treatment Group Who Are Considered a Mycological Cure

  Day 42

• 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

• Proportion of Patients in Each Treatment Group Who Are Considered a Mycological Cure

  Day 42

Study Arms (3)

Test

EXPERIMENTAL

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%

Reference Standard

ACTIVE COMPARATOR

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

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Econazole Nitrate Cream, 1% DRUG

Reference Standard; Test

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mylan Inc.: lead
• DPT Laboratories, Ltd.: collaborator

MeSH Terms

Conditions

Tinea Pedis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Foot Dermatoses; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pruritus; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Abhijit Barve, Head of Global Clinical Research
• Organization: Mylan Inc.

abhijit.barve@mylan.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 26, 2017
• Study Start: March 15, 2016
• Primary Completion: November 17, 2016
• Study Completion: November 17, 2016
• Last Updated: March 7, 2022
• Results First Posted: August 2, 2018

Record last verified: 2022-03