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The objectives of this study were to demonstrate comparable safety and efficacy of Ciclopirox Olamine Cream (Test Product) and Ciclopirox Cream 0.77% (Reference Product) in the treatment of subjects with tinea pedis, and to show the superiority of the active treatments over that of the vehicle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Product | Experimental | Ciclopirox Olamine Cream 0.77% |
|
| Reference Product | Active Comparator | Loprox Cream 0.77% |
|
| Vehicle Product | Placebo Comparator | placebo of test product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciclopirox Olamine Cream | Drug | topical cream |
| |
| Loprox Cream 0.77% |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects in Each Treatment Group With Therapeutic Success | Both Mycological Cure (KOH wet mount negative and fungal culture negative) and Clinical Cure were required to achieve Therapeutic Success | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Mycological Cure | Mycological Cure (KOH wet mount negative and fungal culture negative | 6 weeks |
| Proportion of Subjects With Clinical Cure | Clinical Cure was defined as a signs and symptoms score of <1 for erythema; <1 for scaling; and 0 for pruritus, maceration, fissuring/cracking, and burning/stinging; as well as an assessment that no additional antifungal therapy was required to treat the subject's current episode of tinea pedis |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Product | Ciclopirox cream |
| FG001 | Reference Product | Loprox Cream |
| FG002 | Vehicle Product | placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Product | Ciclopirox cream |
| BG001 | Reference Product | Loprox Cream |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Subjects in Each Treatment Group With Therapeutic Success | Both Mycological Cure (KOH wet mount negative and fungal culture negative) and Clinical Cure were required to achieve Therapeutic Success | Per protocol population | Posted | Number | participants | 6 weeks |
|
6 weeks
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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 Product | Ciclopirox Olamine Cream, USP |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain secondary to head trauma | General disorders | MedDRA 7.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Schwartz | Perrigo Company | 718-960-0119 | jonathan.schwartz@perrigo.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 |
topical cream |
|
|
| Placebo | Drug | topical cream |
|
| 6 weeks |
| Protocol Violation |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| other |
|
| Vehicle Product |
placebo |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Vehicle
|
|
|
| Secondary | Proportion of Subjects With Mycological Cure | Mycological Cure (KOH wet mount negative and fungal culture negative | per protocol population | Posted | Number | participants | 6 weeks |
|
|
|
| Secondary | Proportion of Subjects With Clinical Cure | Clinical Cure was defined as a signs and symptoms score of <1 for erythema; <1 for scaling; and 0 for pruritus, maceration, fissuring/cracking, and burning/stinging; as well as an assessment that no additional antifungal therapy was required to treat the subject's current episode of tinea pedis | per protocol population | Posted | Number | participants | 6 weeks |
|
|
|
| 2 |
| 224 |
| 0 |
| 0 |
| EG001 | Reference Product | Loprox® (ciclopirox) Cream 0.77% | 2 | 226 | 0 | 0 |
| EG002 | Vehicle Product | Vehicle | 1 | 111 | 0 | 0 |
| Near syncope | Cardiac disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| congestive heart failure | Cardiac disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Chest pain | Cardiac disorders | MedDRA 7.0 | Non-systematic Assessment |
|
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| 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 |