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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01640912

Enrollment

Registered

2012-07-16

Start date

2012-06-30

Completion date

2014-05-31

Last updated

2014-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cicatrix, Scar Prevention

Keywords

Scar, Scar prevention, Fibrosis

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.

Interventions

DRUGRXI-109

Single intradermal injection of RXI-109 at incision sites

DRUGPlacebo

Single intradermal injection of placebo at incision sites

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
To assess the safety and tolerability of intradermal administration of RXI-109	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

Measure	Time frame	Description
To assess the effect of RXI-109 on scar formation following small surgical incisions	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026