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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Hea

Brief Summary: 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.

Detailed Summary:
Sponsor: RXi Pharmaceuticals, Corp.

Current Primary Outcome: To assess the safety and tolerability of intradermal administration of RXI-109 [ Time Frame: 12 weeks ]

Evaluate safety and tolerability of RXI-109 at site of intradermal injection. Examination and assessment of any and all local and systemic toxicities


Original Primary Outcome: Same as current

Current Secondary Outcome: To assess the effect of RXI-109 on scar formation following small surgical incisions [ Time Frame: 12 weeks ]

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.


Original Secondary Outcome: Same as current

Information By: RXi Pharmaceuticals, Corp.

Dates:
Date Received: July 12, 2012
Date Started: June 2012
Date Completion:
Last Updated: September 16, 2014
Last Verified: September 2014