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The objective of this study is to evaluate the efficacy and safety of the test formulation of Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.) as compared to the already marketed formulation Naftin® (Naftifine HCl) 1% Cream (Merz Pharmaceuticals) and placebo in patients with tinea pedis and to show the superiority of the active treatments over placebo when dosed once a day for 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naftifine HCl Cream 1% | Experimental | Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.) |
|
| Naftin® (Naftifine HCl) Cream 1% | Active Comparator | Naftin® (Naftifine HCl) Cream 1% (Merz Pharmaceuticals) |
|
| Placebo topical cream | Placebo Comparator | Placebo topical cream (Taro Pharmaceuticals Inc.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naftifine HCl Cream 1% | Drug | Naftifine HCl Cream 1% applied topically once a day for 28 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic Cure | Patients with both mycological cure and clinical cure at the final follow-up visit two weeks fter the end of treatment (Day 42) will be considered therapeutic cures. | 42 Days |
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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 |
|---|---|
| C029178 | naftifine |
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| Naftin® (Naftifine HCl) Cream 1% | Drug | Naftin® (Naftifine HCl) Cream 1% applied topically once a day for 28 days. |
|
| Placebo topical cream | Drug | Placebo topical cream applied topically once a day for 28 days. |
|
| 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 |