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The primary objective of this study is to determine the comparability of the safety and efficacy of a generic Butenafine Hydrochloride Cream, 1% (test product) and Lotrimin Ultra® (the reference listed drug) in subjects with interdigital tinea pedis. It will also be determined whether the efficacy of each of the two active treatments is superior to that of the vehicle cream (placebo).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Butenafine Hydrochloride Cream, 1% | Experimental | Butenafine Hydrochloride Cream, 1% (Taro Pharmaceuticals, Inc.) |
|
| Lotrimin Ultra® | Active Comparator | Lotrimin Ultra® (Butenafine Hydrochloride Cream, 1%) (Schering Plough HealthCare Products Inc.) |
|
| Butenafine Vehicle | Placebo Comparator | Butenafine Cream vehicle (Taro Pharmaceuticals Inc.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Butenafine Hydrochloride Cream, 1% | Drug | Butenafine Hydrochloride Cream, 1% applied twice daily for 7 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic Cure | Subjects with both clinical cure and mycologic cure are considered therapeutic cures. | 42 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Symbio CRO | http://symbioresearch.com/ | Study Chair |
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| Lotrimin Ultra® | Drug | Lotrimin Ultra® (Butenafine Hydrochloride Cream, 1%) applied twice daily for 7 consecutive days. |
|
| Butenafine Vehicle | Drug | Butenafine Vehicle applied twice daily for 7 consecutive days. |
|
| 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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| ID | Term |
|---|---|
| C067594 | butenafine |
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