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The objective of this study is to demonstrate that Oxiconazole nitrate 1% topical cream is effective for the treatment of patients with moderate to severe Tinea pedis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxiconazole Nitrate Cream 1% | Experimental |
| |
| Oxiconazole Nitrate Cream 1% (Oxistat®) | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxiconazole Nitrate Cream 1% | Drug | Oxiconazole Nitrate Cream 1% applied to affected area once a day for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic Cure | Clinical & Mycological Cure at 6 weeks | Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Cure | Proportion of patients considered a clinical cure at 6 weeks | Day 42 |
| Mycological Cure | Proportion of patients with both KOH & culture negative at 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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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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| ID | Term |
|---|---|
| C022155 | oxiconazole |
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| Oxiconazole Nitrate Cream 1% (Oxistat®) | Drug | Oxiconazole Nitrate Cream 1%(Oxistat®)applied to affected area once a day for 28 days |
|
| Placebo | Drug | Placebo applied to affected area once a day for 28 days |
|
| Day 42 |
| 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 |