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

RXi Pharmaceuticals, Corp.0 sites15 target enrollmentJune 2012

ConditionsCicatrix Scar Prevention

InterventionsRXI-109 Placebo

DrugsRXI-109 Placebo

Overview

Phase: Phase 1
Intervention: RXI-109
Conditions: Cicatrix
Sponsor: RXi Pharmaceuticals, Corp.
Enrollment: 15
Primary Endpoint: To assess the safety and tolerability of intradermal administration of RXI-109
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 2012

End Date

May 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

RXi Pharmaceuticals, Corp.

Responsible Party

Sponsor

Eligibility Criteria

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