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The objective of this study is to compare the efficacy and safety of the test formulation of Naftifine Hydrochloride Cream 2% to Naftin® (Naftifine Hydrochloride) 2% Cream in a 6 week study in patients with tinea pedis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naftifine Hydrochloride Cream 2% | Experimental | Naftifine Hydrochloride Cream 2% (Taro Pharmaceuticals Inc.) |
|
| Naftin® Cream 2% | Active Comparator | Naftin® (Naftifine Hydrochloride) Cream 2% |
|
| Placebo Topical Cream | Placebo Comparator | Placebo Topical Cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naftifine Hydrochloride Cream 2% | Drug | Naftifine Hydrochloride Cream 2% (Taro Pharmaceuticals Inc.) applied once-daily for two weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic Cure | The proportion of subjects with therapeutic cure (both mycological cure and clinical cure) at the test-of-cure visit conducted four weeks after the end of treatment. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catawba Research | http://catawbaresearch.com/contact/ | Study Chair |
| Natalie Yantovskiy | Taro Pharmaceuticals USA Inc. | Study Director |
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|
| Naftin® (Naftifine Hydrochloride) Cream 2% | Drug | Naftin® (Naftifine Hydrochloride) Cream 2% (Merz Pharmaceuticals, LLC) applied once-daily for two weeks. |
|
|
| Placebo Topical Cream | Drug | Placebo Topical Cream (Taro Pharmaceuticals Inc.) applied once-daily for two weeks. |
|
|
| 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 |
|---|---|
| C029178 | naftifine |
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