Clinical Trial: Evaluation of Safety, PK, and Preliminary Effects on Scar Formation of Multiple Intradermal Administrations of RXI-109

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

Official Title: A Phase 1 Single Center, Randomized, Double-Blind, Ascending, Multi-Dose, Within-Subject Controlled Study of RXI-109 for the Treatment of Incision Scars Made in the Abdomi

Brief Summary: The purpose of this trial is to evaluate the safety and tolerability of multiple (3) intradermal doses of RXI-109 at small surgical incisions in the abdominal skin of healthy volunteers. The effect of RXI-109 versus placebo on scarring at these incision sites will be evaluated visually, histologically, and by biomarker analysis.

Detailed Summary:
Sponsor: RXi Pharmaceuticals, Corp.

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

Evaluate safety and tolerability of multiple administrations of RXI-109 at the site of intradermal injection. Examine and assess any and all local and systemic toxicities


Original Primary Outcome: Same as current

Current Secondary Outcome: To assess the effect of multiple intradermal administrations of RXI-109 on scar formation [ Time Frame: 12 weeks ]

Assess visual outcome and histology of scars. Digital images of the RXI-109 and placebo-treated incisions/scars will be captured and scored.


Original Secondary Outcome: Same as current

Information By: RXi Pharmaceuticals, Corp.

Dates:
Date Received: January 28, 2013
Date Started: December 2012
Date Completion:
Last Updated: December 2, 2014
Last Verified: December 2014