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

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.

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Key information

Conditions

Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Scar Prevention

Age range

21 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

St Louis, Missouri, 63141, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RXI-109

Drug

Single intradermal injection of RXI-109 at incision sites

Placebo

Drug

Single intradermal injection of placebo at incision sites

Primary outcomes

To assess the safety and tolerability of intradermal administration of RXI-109

Time frame: 12 weeks

Evaluate safety and tolerability of RXI-109 at site of intradermal injection. Examination and assessment of any and all local and systemic toxicities

Secondary outcomes

To assess the effect of RXI-109 on scar formation following small surgical incisions

Time frame: 12 weeks

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.

Sponsors and collaborators

Lead sponsor

RXi Pharmaceuticals, Corp.

Industry

Registry information

Official study 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

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Jul 16, 2012
Registry last updated: Sep 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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