Evaluation of the Safety, Pharmacokinetics, and Preliminary Effect on Scar Formation by RXI-109

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1 Single Center, Randomized, Double-Blind, Ascending Dose, Within-Subject Controlled Study of RXI-109 for the Treatment of Incision Scars Made in the Pannus of Healthy Women Who Will Later Undergo Elective Abdominoplasty

Conditions
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Cicatrix, Scar Prevention

Intervention / Treatment
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* Drug: RXI-109
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be a female in general good health with normal screening values Subject must be a good surgical candidate for an elective abdominoplasty Subjects must not be pregnant or lactating and utilize an effective method of contraception (if child-bearing potential exists) Exclusion Criteria: Currently pregnant or lactating BMI greater than 35 at screening Use of tobacco or nicotine-containing products within the month prior to enrollment and while on study Any medical condition or current therapy which would make the subject unsuitable for this study in the opinion of the PI

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RXI-109<br> | Drug: RXI-109<br>* Single intradermal injection of RXI-109 at incision sites<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Single intradermal injection of placebo at incision sites<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scar, Scar prevention, Fibrosis