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| Name | Class |
|---|---|
| DPT Laboratories, Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days |
|
| Reference Standard | Active Comparator | Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days |
|
| Placebo | Placebo Comparator | Placebo Cream, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Econazole Nitrate Cream, 1% | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Test | Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Econazole Nitrate Cream, 1% |
| FG001 | Reference Standard | Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Econazole Nitrate Cream, 1% |
| FG002 | Placebo | Placebo Cream, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test | Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Econazole Nitrate Cream, 1% |
| BG001 | Reference Standard |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Active Treatments of the Per Protocol Population | Posted | Count of Participants | Participants | Day 42 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test | Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Econazole Nitrate Cream, 1% |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abhijit Barve, Head of Global Clinical Research | Mylan Inc. | abhijit.barve@mylan.com |
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| ID | Term |
|---|---|
| D014008 | Tinea Pedis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| Drug |
|
| Day 42 |
| Proportion of Patients in Each Active Treatment Group Who Are Considered a Mycological Cure | 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) | 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 | 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 |
Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days
Econazole Nitrate Cream, 1%
| BG002 | Placebo | Placebo Cream, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Placebo |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days
Econazole Nitrate Cream, 1%
|
|
|
| Primary | 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 | Modified Intent to Treat. Patients who are missing mycological culture data at baseline are not included in the analysis. Patients who are missing mycological culture data at the test of cure visit are not included in the analysis unless they were a treatment failure. | Posted | Count of Participants | Participants | Day 42 |
|
|
|
|
| Secondary | 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) | 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 | Active treatment groups of the Per Protocol population | Posted | Count of Participants | Participants | Day 42 |
|
|
|
|
| Secondary | Proportion of Patients in Each Active Treatment Group Who Are Considered a Mycological Cure | 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 | Active treatment groups of the Per Protocol population | Posted | Count of Participants | Participants | Day 42 |
|
|
|
|
| Secondary | 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) | 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 | Modified Intent to Treat | Posted | Count of Participants | Participants | Day 42 |
|
|
|
|
| Secondary | Proportion of Patients in Each Treatment Group Who Are Considered a Mycological Cure | 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 | Modified Intent to Treat. Patients who are missing mycological culture data at baseline are not included in the analysis. Patients who are missing mycological culture data at the test of cure visit are not included in the analysis unless they were a treatment failure. | Posted | Count of Participants | Participants | Day 42 |
|
|
|
|
| 0 |
| 351 |
| 0 |
| 351 |
| EG001 | Reference Standard | Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Econazole Nitrate Cream, 1% | 0 | 350 | 0 | 350 |
| EG002 | Placebo | Placebo Cream, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Placebo | 0 | 175 | 0 | 175 |
Investigator shall not publish, or seek to publish, either in whole or in part any results of the study without the written consent of CRO.
| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D005533 | Foot Dermatoses |
| D005534 | Foot Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011537 | Pruritus |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Superiority |
| Superiority |
| Superiority |