A Phase 1 interventional study of RXI-109 and Placebo in Cicatrix and Scar Prevention, sponsored by RXi Pharmaceuticals, Corp.. Completed. Open to participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-03.
Sponsored by RXi Pharmaceuticals, Corp. · Phase 1, Interventional, and Treatment
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.
307 studies on the registry are indexed under Cicatrix; 50 are open to participants now.
This study's enrollment of 15 is below the median of 39 across 251 interventional studies indexed under Cicatrix.
Browse Cicatrix studies →RXi Pharmaceuticals, Corp. is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Drug: RXI-109 · Drug: Placebo
Drug: RXI-109 · Drug: Placebo
Multiple intradermal injections of RXI-109 at incision sites
Multiple intradermal injections of placebo at incision sites
To assess the safety and tolerability of multiple intradermal administrations of RXI-109
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
Time frame: 12 weeks
To assess the effect of multiple intradermal administrations of RXI-109 on scar formation
Assess visual outcome and histology of scars. Digital images of the RXI-109 and placebo-treated incisions/scars will be captured and scored.
Time frame: 12 weeks
To assess the timeline and levels of biomarkers
Analysis of immunohistochemical analysis of biomarkers common to the scar formation pathway.
Time frame: 12 weeks
No study locations are listed for this record.
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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RXi Pharmaceuticals, Corp.