Evaluation of the Safety, Pharmacokinetics, and Preliminary Effect on Scar Formation by RXI-109
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- To assess the safety and tolerability of intradermal administration of RXI-109 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Evaluate safety and tolerability of RXI-109 at site of intradermal injection. Examination and assessment of any and all local and systemic toxicities
- To assess the effect of RXI-109 on scar formation following small surgical incisions [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Single intradermal injection of RXI-109 at incision sites
|Placebo Comparator: Placebo||
Single intradermal injection of placebo at incision sites