Trial | NCT01640912  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    rxi-109 ...

  • Study Participants

    15
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 Started
Jun 30
2012
Primary Completion
Apr 30
2014
Study Completion
May 31
2014
Last Update
Sep 17
2014
Estimate

Drug RXI-109

Single intradermal injection of RXI-109 at incision sites

Drug Placebo

Single intradermal injection of placebo at incision sites

RXI-109 Experimental

Placebo Placebo Comparator

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
No Results Posted