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To examine the safety and optimal duration of Luliconazole Cream 1% treatments for 14 days or 28 days to achieve "complete clearance" at 2 weeks post treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Luliconazole Cream 1% - 2 wks | Experimental | Daily treatment with Luliconazole Cream 1% for 2 weeks |
|
| Luliconazole Cream 1% - 4 wks | Experimental | Daily treatment with Luliconazole Cream 1% for 4 weeks |
|
| Placebo Comparator - 2 wks | Placebo Comparator | Daily treatment with Vehicle Cream for 2 weeks |
|
| Placebo Comparator - 4 wks | Placebo Comparator | Daily treatment with Vehicle Cream for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luliconazole Cream 1% - 2 wks | Drug | Topical cream applied daily for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who achieve complete clearance at 2 weeks post treatment | Two weeks post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who achieve effective treatment at 2 and 4 weeks post treatment | 2 and 4 weeks post treatment |
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Inclusion Criteria:
Exclusion Criteria:
Subjects with moccasin (dry type) tinea pedis; with concomitant onychomycosis of the fingernails and/or toenails on the evaluated foot, with severe dermatophytoses, a concurrent tinea infection or bacterial skin infection on the evaluated foot;
Female subjects who are pregnant and/or nursing or planning a pregnancy during the course of the trial.
Subjects who are immunocompromised (due to disease, e.g., HIV or medications
Subjects with a history of intolerance or hypersensitivity to imidazole compounds or the inactive components of the cream;
Subjects with a life-threatening condition (e.g., autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months.
Subjects using the following medications:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fridley | Minnesota | 55432 | United States | |||
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| Placebo Comparator -2 wks | Drug | Placebo cream applied daily for 2 weeks |
|
| Luliconazole Cream 1% - 4 wks | Drug | Topical cream applied daily for 4 weeks |
|
| Placebo Comparator - 4 wks | Drug | Placebo cream applied daily for 4 weeks |
|
| Portland |
| Oregon |
| 97210 |
| United States |
| Austin | Texas | 78759 | United States |
| College Station | Texas | 77840 | United States |
| 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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