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This open-label, pilot study will evaluate the tolerance and change in the microbiome from the use of APR-TD011 ((RLF-TD011) wound cleansing spray for the treatment of CTCL skin lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTCL participants | Experimental | Visits will include screening, pre-treatment (week 0), weeks 4 and 8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APR-TD011 (RLF-TD011) | Combination Product | APR-TD011 (RLF-TD011) wound cleansing spray (drug/device combination product with a 510k clearance that is commercially marketed in the US for use by or on the order of a physician. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in microbiome species | Reduction of Staphylococcus aureus relative abundance between baseline and Week 4 | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dermatology CTU | Contact | 312-503-5944 | NUderm-research@northwestern.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology CTU | Chicago | Illinois | 60611 | United States |
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|
| ID | Term |
|---|---|
| D016410 | Lymphoma, T-Cell, Cutaneous |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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