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The purpose of this study is to examine the long-term safety of treating recurrent episodes of tinea pedis for 14 days for each recurrence and recurrent episodes of tinea corporis or tinea cruris for 7 days for each recurrence with Product 33525.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety Population | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Product 33525 | Drug | Daily dosing for 2 weeks each recurrence for patients with tinea pedis and Daily dosing for 1 week each recurrence for patients with tinea cruris and tinea corporis |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects with Adverse Events | To examine the long-term safety of treating tinea pedis, tinea corporis or tinea cruris, treatment-emergent adverse events occurring during the study will be recorded. Adverse events will be summarized by the number of subjects reporting events, system organ class, preferred term, severity, relationship to study drug, and seriousness. Baseline and end of study laboratory assessments will be conducted. | One Year |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Cure and Mycological Cure | Proportion of patients achieving effective treatment | 1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fremont | California | United States | ||||
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| Los Angeles |
| California |
| United States |
| Miami | Florida | United States |
| Miramar | Florida | United States |
| St. Petersburg | Florida | United States |
| Augusta | Georgia | United States |
| Evansville | Indiana | United States |
| Warren | Michigan | United States |
| Omaha | Nebraska | United States |
| Paramus | New Jersey | United States |
| Albuquerque | New Mexico | United States |
| Cincinnati | Ohio | United States |
| Hershey | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Goodletsville | Tennessee | United States |
| Austin | Texas | United States |
| College Station | Texas | United States |
| Plano | Texas | United States |
| San Antonio | Texas | United States |
| Lynchburg | Virginia | United States |
| Belize City | Belize District | Belize |
| San Salvador | El Salvador |
| San Pedro | Sula | Honduras |
| Cidra | Puerto Rico |
| ID | Term |
|---|---|
| D014008 | Tinea Pedis |
| D000084002 | Tinea Cruris |
| D014005 | Tinea |
| ID | Term |
|---|---|
| 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 |
| D007402 | Intertrigo |
| D003872 | Dermatitis |
| D017443 | Skin Diseases, Eczematous |
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