Evaluation of Safety, PK, and Preliminary Effects on Scar Formation of Multiple Intradermal Administrations of RXI-109

A Phase 1 Single Center, Randomized, Double-Blind, Ascending, Multi-Dose, Within-Subject Controlled Study of RXI-109 for the Treatment of Incision Scars Made in the Abdominal Skin of Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01780077

Enrollment

Registered

2013-01-30

Start date

2012-12-31

Completion date

2014-11-30

Last updated

2014-12-03

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 purpose of this trial is to evaluate the safety and tolerability of multiple (3) intradermal doses of RXI-109 at small surgical incisions in the abdominal skin of healthy volunteers. The effect of RXI-109 versus placebo on scarring at these incision sites will be evaluated visually, histologically, and by biomarker analysis.

Interventions

DRUGRXI-109

Multiple intradermal injections of RXI-109 at incision sites

DRUGPlacebo

Multiple intradermal injections 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

ALL

Age

21 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Males and females, 21-50 years of age * General good health; if female not pregnant or lactating * Phototype 3 and above based on the Fitzpatrick scale.

Exclusion criteria

* Pregnant or lactating * Use of tobacco or nicotine-containing products within 1 month prior to enrollment and while on study * Type 1 or 2 diabetes mellitus * A history or presence of any medical condition or therapy that would make the subject an unsafe candidate in the opinion of the investigator

Design outcomes

Primary

Measure	Time frame	Description
To assess the safety and tolerability of multiple intradermal administrations of RXI-109	12 weeks	Evaluate safety and tolerability of multiple administrations of RXI-109 at the site of intradermal injection. Examine and assess any and all local and systemic toxicities

Secondary

Measure	Time frame	Description
To assess the effect of multiple intradermal administrations of RXI-109 on scar formation	12 weeks	Assess visual outcome and histology of scars. Digital images of the RXI-109 and placebo-treated incisions/scars will be captured and scored.

Other

Measure	Time frame	Description
To assess the timeline and levels of biomarkers	12 weeks	Analysis of immunohistochemical analysis of biomarkers common to the scar formation pathway.

Outcome results

None listed

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