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The purpose of this study is to determine the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective revision of a pre-existing hypertrophic abdominal scar.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RXI-109 | Experimental | Treatment with RXI-109 on one side of revised scar and a placebo comparator on the other side. Treatment to begin either immediately or 2 weeks following the scar revision surgery. |
|
| Placebo | Placebo Comparator | Treatment with RXI-109 on one side of revised scar and a placebo comparator on the other side. Treatment to begin either immediately or 2 weeks following the scar revision surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RXI-109 | Drug | surgery. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in recurrence of hypertrophic scarring after scar revision surgery | To evaluate the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective revision of a hypertrophic abdominal scar | 9 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 revision of a hypertrophic abdominal scar | 9 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 |
|---|---|---|---|---|---|---|
| Lake Worth | Florida | 33461 | United States | |||
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| Drug |
surgery. |
|
| Chicago |
| Illinois |
| 60611 |
| United States |
| St Louis | Missouri | 63141 | United States |
| Huntersville | North Carolina | 28078 | United States |
| San Pedro Sula | Honduras |
| ID | Term |
|---|---|
| D017439 | Cicatrix, Hypertrophic |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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