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The primary purpose of this study is to evaluate the safety and tolerability of a single intradermal administration of RXI-109 at small surgical incisions in the abdominal skin that will later be removed during an elective abdominoplasty. The effect of RXI-109 versus placebo on scarring at these incision sites will be evaluated visually and histologically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RXI-109 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RXI-109 | Drug | Single intradermal injection of RXI-109 at incision sites |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of intradermal administration of RXI-109 | Evaluate safety and tolerability of RXI-109 at site of intradermal injection. Examination and assessment of any and all local and systemic toxicities | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of RXI-109 on scar formation following small surgical incisions | Visual outcome and histology of scars will be assessed. Digital images of the RXI-109 and placebo-treated incisions/scars will be captured and assessed by a masked, independent, expert panel. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Louis | Missouri | 63141 | United States |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo |
| Drug |
Single intradermal injection of placebo at incision sites |
|