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| Name | Class |
|---|---|
| AmDerma Pharmaceuticals, LLC | INDUSTRY |
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This is a study of the safety and efficacy of Econazole Nitrate Foam 1% and the Foam Vehicle in subjects with interdigital tinea pedis (athlete's foot between the toes). This is a 6 week study which has a 4 week treatment period and a 2 week follow-up evaluation. The study will also utilize Econazole Nitrate Cream 1% (for safety comparison) and a Placebo cream for blinding purposes only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Econazole Nitrate Foam 1% | Experimental | Study medication |
|
| Vehicle Foam | Placebo Comparator | Placebo medication |
|
| Econazole Nitrate Cream 1% | Active Comparator | Econazole Nitrate Cream 1% |
|
| Placebo Cream | Sham Comparator | Placebo Cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Econazole Nitrate Foam 1% | Drug | Econazole Nitrate Foam 1% applied once a day for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Cure | Complete Cure is defined as a negative KOH and negative fungal culture and no evidence of clinical disease as indicated by scores of 0 (none) for each sign and system at Day 43, analysis of the Econazole Nitrate Foam 1% and Foam Vehicle treatment groups only. | Day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Effective Treatment | Effective Treatment defined as negative KOH, negative fungal culture, no or mild (a score of 0 or 1) erythema and/or scaling with all other signs or symptoms being absent (score = 0) at Day 43, analysis of the Econazole Nitrate Foam 1% and Foam Vehicle treatment groups only. | Day 43 |
| Mycological Cure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Piacquadio, MD | Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunil S. Dhawan, MD | Fremont | California | 94538 | United States | ||
| Guy F. Webster, MD, PhD |
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| Vehicle Foam | Drug | Vehicle Foam applied once a day for 4 week |
|
| Econazole Nitrate Cream 1% | Drug | Econazole Nitrate Foam 1% applied once a day for 4 weeks |
|
| Placebo Cream | Other | Placebo cream applied once a day for 4 weeks |
|
Mycological Cure defined as negative KOH and negative culture at Day 43, analysis of the Econazole Nitrate Foam 1% and Foam Vehicle treatment groups only. |
| Day 43 |
| Hockessin |
| Delaware |
| 19707 |
| United States |
| Marta I. Rendon, MD | Boca Raton | Florida | 33486 | United States |
| Jonathan Kantor, MD | Jacksonville | Florida | 32204 | United States |
| Steven E. Kempers, MD | Fridley | Minnesota | 55432 | United States |
| Joel Schlessinger, MD | Omaha | Nebraska | 68144 | United States |
| Phoebe Rich, MD | Portland | Oregon | 97210 | United States |
| Edward J. Primka III, MD | Knoxville | Tennessee | 37917 | United States |
| Michael T. Jarratt, MD | Austin | Texas | 78759 | United States |
| William Abramovits, MD | Dallas | Texas | 75230 | United States |
| David M. Pariser, MD, FAAD, FACP | Norfolk | Virginia | 23507 | United States |
| Harry H. Sharata, MD, PhD | Madison | Wisconsin | 53719 | 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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