- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03129321
Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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
|
|
Active Comparator: Reference Standard
Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days
|
|
Placebo Comparator: Placebo
Placebo Cream, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 42
|
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
|
Day 42
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 42
|
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
|
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)
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
|
Day 42
|
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
|
Day 42
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Foot Diseases
- Bacterial Infections and Mycoses
- Skin Diseases, Infectious
- Mycoses
- Skin Manifestations
- Dermatomycoses
- Foot Dermatoses
- Pruritus
- Tinea
- Tinea Pedis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Econazole
Other Study ID Numbers
- 71532902
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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