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The study is being done to determine and compare the safety and effectiveness of an investigational combination therapy (low and high concentrations) versus mono-therapy (low and high concentrations) or mono-therapy (fixed concentration) in subjects with moccasin type tinea pedis.
UHE-103 cream is an investigational combination drug to treat moccasin type tinea pedis, a fungal infection that affects the feet and toes. Eligible subjects will be assigned to one of the 5 possible treatment groups and participate for a total of 6 weeks. Subjects will apply their assigned test drug twice daily for 2 weeks. Each subject will then be assessed for safety and efficacy at week 4 and week 6. There will be a total of 5 clinic visits: 1 screening/baseline visit (Day 1), 2 treatment visits (Days 8 and 15), and 2 follow-up visits (Days 29 and 43).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UHE-103A1 cream | Experimental | Topical cream applied twice daily for 2 weeks. |
|
| UHE-103A2 cream | Experimental | Topical cream applied twice daily for 2 weeks. |
|
| UHE-103B cream | Experimental | Topical cream applied twice daily for 2 weeks. |
|
| UHE-103A1B cream | Experimental | Topical cream applied twice daily for 2 weeks. |
|
| UHE-103A2B cream | Experimental | Topical cream applied twice daily for 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UHE-103A1 cream | Drug | Investigational mono-therapy cream (containing drug A [low dose]). Drug A is an antifungal agent. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Cure at End of Study | Proportion of subjects with Complete Cure (negative fungal test & no clinical disease-induced signs and symptoms) at end of study (EOS). | Day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Effective treatment | Proportion of subjects with Effective Treatment (negative fungal test & no to mild clinical disease-induced signs and symptoms) at EOS. | Day 43 |
| Mycological Cure | Proportion of subjects with Mycological Cure (negative fungal test) at EOS. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion or exclusion criteria assessed by the study staff may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Marietta Radona, MD | Therapeutics, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 03 | San Diego | California | 92123 | United States | ||
| Site 12 |
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Five Arms:
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| UHE-103A2 cream | Drug | Investigational mono-therapy cream (containing drug A [low dose]). Drug A is an antifungal agent. |
|
| UHE-103B cream | Drug | Comparator mono-therapy cream (containing drug B). Drug B is a keratolytic agent. |
|
| UHE-103A1B cream | Drug | Investigational combination-therapy cream (containing drug A [low dose antifungal] + drug B [keratolytic]). |
|
| UHE-103A2B cream | Drug | Investigational combination-therapy cream (containing drug A [high dose antifungal] + drug B [keratolytic]). |
|
| Day 43 |
| Melbourne |
| Florida |
| 32935 |
| United States |
| Site 06 | Miami | Florida | 33144 | United States |
| Site 09 | North Miami Beach | Florida | 33162 | United States |
| Site 07 | Rolling Meadows | Illinois | 60008 | United States |
| Site 11 | Fridley | Minnesota | 55432 | United States |
| Site 04 | Rochester | New York | 14623 | United States |
| Site 01 | Austin | Texas | 78759 | United States |
| Site 02 | Houston | Texas | 77055 | United States |
| Site 10 | San Antonio | Texas | 78229 | United States |
| Site 05 | Norfolk | Virginia | 23502 | United States |
| Site 08 | Cidra | 00739 | Puerto Rico |
| 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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