NCT01640912

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

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 Healthy Women Who Will Later Undergo Elective Abdominoplasty

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

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.

Conditions

• Cicatrix
• Scar Prevention

Interventions

Type	Name	Description
DRUG	RXI-109	Single intradermal injection of RXI-109 at incision sites
DRUG	Placebo	Single intradermal injection of placebo at incision sites

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-04-01
• Completion: 2014-05-01
• First posted: 2012-07-16
• Last updated: 2014-09-17

Locations

1 site across 1 country: United States