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To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Treatment with RXI-109 at the site of one excised keloid and a placebo at the site of a second excised keloid. Dosing to begin at the time of surgery. |
|
| Cohort 2 | Experimental | Treatment with RXI-109 at the site of one excised keloid and a placebo at the site of a second excised keloid. Dosing to begin two weeks after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RXI-109 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in the recurrence of a keloid after keloid excision | To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of RXI-109 | To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after elective excision of a keloid | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Pavco, PhD | RXi Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami | Florida | 33137 | United States | |||
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| ID | Term |
|---|---|
| D007627 | Keloid |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005355 | Fibrosis |
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|
| St Louis |
| Missouri |
| 63141 |
| United States |
| San Cristobal | Dominican Republic |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |