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The objectives of this study were to demonstrate comparable safety and efficacy of Ciclopirox Olamine Topical Suspension (Test Product) and Ciclopirox Topical Suspension 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 Topical Suspension |
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| Reference Product | Active Comparator | Loprox® Topical Suspension 0.77% |
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| Vehicle Product | Placebo Comparator | placebo of test product |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciclopirox Olamine Topical Suspension | Drug | topical suspension |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects in Each Treatment Group With Therapeutic Success | Therapeutic success was defined as having both Mycological Cure (potassium hydroxide [KOH] wet mount negative and fungal culture negative) and Clinical Cure | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Mycological Cure | Potassium hydroxide [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 Olamine Topical Suspension; the Test Product was applied treatment two times a day for 4 weeks |
| FG001 | Reference Product | Loprox® Topical Suspension 0.77%; the Reference Product was applied treatment two times a day for 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Ciclopirox Topical Suspension 0.77%-Reference Product |
| Drug |
topical suspension |
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| Ciclopirox Olamine Topical Suspension-Placebo | Drug | topical suspension |
|
| 6 weeks |
| FG002 | Vehicle Product | placebo of test product was applied treatment two times a day for 4 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Product | Ciclopirox Olamine Topical Suspension |
| BG001 | Reference Product | Loprox® Topical Suspension 0.77% |
| BG002 | Vehicle Product | placebo of test product |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Proportion of Subjects in Each Treatment Group With Therapeutic Success | Therapeutic success was defined as having both Mycological Cure (potassium hydroxide [KOH] wet mount negative and fungal culture negative) and Clinical Cure | Per protocol population | Posted | Number | participants | 6 weeks |
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| Secondary | Proportion of Subjects With Mycological Cure | Potassium hydroxide [KOH] wet mount negative and fungal culture negative | Posted | Number | participants | 6 weeks |
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| 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 | Posted | Number | participants | 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 Topical Suspension | 0 | 220 | 0 | 220 | ||
| EG001 | Reference Product | Loprox® Topical Suspension 0.77% | 2 | 224 | 0 | 224 | ||
| EG002 | Vehicle Product | placebo of test product | 4 | 109 | 0 | 109 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | Cardiac disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Perforated sigmoid colon | Gastrointestinal disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Subarachnoid hemorrhage; MCA aneurysm; PCOM | Nervous system disorders | MedDRA (7.1) |
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| Blood clots spleen | Gastrointestinal disorders | MedDRA (7.1) |
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| Seizures (transient ischaemic attack) | Nervous system disorders | MedDRA (7.1) |
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| Right hip fracture | Musculoskeletal and connective tissue disorders | MedDRA (7.1) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Schwartz | Perrigo | 718-960-0119 | jonathan.schwartz@perrigo.com |
| ID | Term |
|---|---|
| D014008 | Tinea Pedis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| 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 |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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