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This study will test whether addition of imiquimod to standard antimony therapy provides a significant benefit in subjects with newly diagnosed cutaneous leishmaniasis. Based on our previous results, we hypothesize that lesions in patients who receive the combined treatment of pentavalent antimony and imiquimod as a first line therapy will resolve more rapidly and produce less scarring than treatment with pentavalent antimony alone.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imiquimod | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Time to healing | ||
| Reduction of scaring |
| Measure | Description | Time Frame |
|---|---|---|
| Safety (measured by AE reporting) during treatment and follow up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Royce, Dr | Drugs for Neglected Diseases initiative | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPCH | Cusco | Peru | ||||
| IMT Alexander Von Humboldt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19636365 | Derived | Miranda-Verastegui C, Tulliano G, Gyorkos TW, Calderon W, Rahme E, Ward B, Cruz M, Llanos-Cuentas A, Matlashewski G. First-line therapy for human cutaneous leishmaniasis in Peru using the TLR7 agonist imiquimod in combination with pentavalent antimony. PLoS Negl Trop Dis. 2009 Jul 28;3(7):e491. doi: 10.1371/journal.pntd.0000491. |
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| ID | Term |
|---|---|
| D016773 | Leishmaniasis, Cutaneous |
| ID | Term |
|---|---|
| D007896 | Leishmaniasis |
| D056986 | Euglenozoa Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
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| ID | Term |
|---|---|
| D000077271 | Imiquimod |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Lima |
| Peru |
| D007239 |
| Infections |
| D012876 | Skin Diseases, Parasitic |
| D000079426 | Vector Borne Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006571 | Heterocyclic Compounds |