NCT01780077

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

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 Abdominal Skin of Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: RXi Pharmaceuticals, Corp. · Industry
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cicatrix
• Scar Prevention

Interventions

Type	Name	Description
DRUG	RXI-109	Multiple intradermal injections of RXI-109 at incision sites
DRUG	Placebo	Multiple intradermal injections of placebo at incision sites

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-06-01
• Completion: 2014-11-01
• First posted: 2013-01-30
• Last updated: 2014-12-03