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

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.

Study Overview

• Status: Completed
• Conditions: Cicatrix; Scar Prevention
• Intervention / Treatment: Drug: RXI-109; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States, 63141

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Subject must be a female in general good health with normal screening values
• Subject must be a good surgical candidate for an elective abdominoplasty
• Subjects must not be pregnant or lactating and utilize an effective method of contraception (if child-bearing potential exists)

Exclusion Criteria:

• Currently pregnant or lactating
• BMI greater than 35 at screening
• Use of tobacco or nicotine-containing products within the month prior to enrollment and while on study
• Any medical condition or current therapy which would make the subject unsuitable for this study in the opinion of the PI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Single intradermal injection of placebo at incision sites
Experimental: RXI-109	Drug: RXI-109; Single intradermal injection of RXI-109 at incision sites

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the safety and tolerability of intradermal administration of RXI-109	Evaluate safety and tolerability of RXI-109 at site of intradermal injection. Examination and assessment of any and all local and systemic toxicities	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the effect of RXI-109 on scar formation following small surgical incisions	Visual outcome and histology of scars will be assessed. Digital images of the RXI-109 and placebo-treated incisions/scars will be captured and assessed by a masked, independent, expert panel.	12 weeks

Collaborators and Investigators

• Sponsor: RXi Pharmaceuticals, Corp.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: July 12, 2012
• First Submitted That Met QC Criteria: July 12, 2012
• First Posted (Estimate): July 16, 2012

Study Record Updates

• Last Update Posted (Estimate): September 17, 2014
• Last Update Submitted That Met QC Criteria: September 16, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Fibrosis; Scar; Scar prevention
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: RXI-109-1201