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

Cicatrix Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01640912
Study type Interventional
Source RXi Pharmaceuticals, Corp.
Contact
Status Completed
Phase Phase 1
Start date June 2012
Completion date May 2014
View Details
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