Clinical Trial: A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery in Healthy Adults

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

Official Title: A Multi-Center, Prospective, Randomized, Double-Blind, Within-Subject Controlled, Phase 2a Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery on Transver

Brief Summary: The purpose of this study is to determine the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective revision of a pre-existing hypertrophic abdominal scar.

Detailed Summary:
Sponsor: RXi Pharmaceuticals, Corp.

Current Primary Outcome: Reduction in recurrence of hypertrophic scarring after scar revision surgery [ Time Frame: 9 months ]

To evaluate the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective revision of a hypertrophic abdominal scar


Original Primary Outcome: Same as current

Current Secondary Outcome: Safety of RXI-109 [ Time Frame: 9 months ]

To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after elective revision of a hypertrophic abdominal scar


Original Secondary Outcome: Same as current

Information By: RXi Pharmaceuticals, Corp.

Dates:
Date Received: January 6, 2014
Date Started: November 2013
Date Completion:
Last Updated: June 20, 2016
Last Verified: June 2016