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

Completed · Phase 1 · Has a placebo group

Conditions studied: Cicatrix, Scar Prevention

In brief

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.

Key facts

Study ID

NCT01640912

Run by

RXi Pharmaceuticals, Corp.

People needed

15

Starts

2012-06-01

Expected to finish

2014-05-01

Last updated by the study team

2014-09-17

Who can join

Age: 21 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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