A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery in Healthy Adults

A Multi-Center, Prospective, Randomized, Double-Blind, Within-Subject Controlled, Phase 2a Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery on Transverse Hypertrophic Scars on the Lower Abdomen Resulting From Previous Surgeries in Healthy Adults

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02030275

Enrollment

Registered

2014-01-08

Start date

2013-11-30

Completion date

2016-06-30

Last updated

2016-06-21

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

Conditions

Hypertrophic Scar

Keywords

Hypertrophic scar, Cicatrix, Scar prevention, Scar revision

Brief summary

The purpose of this study is to determine the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective revision of a pre-existing hypertrophic abdominal scar.

Interventions

DRUGRXI-109

surgery.

DRUGPlacebo

surgery.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Adults, 21-55 years of age in general good health * Previous partial hysterectomy, Cesarean section or abdominoplasty surgery resulting in a transverse hypertrophic scar of ≥ 11 cm in length * Scar to be revised must have been present for \> 9 months

Exclusion criteria

* Use of tobacco or nicotine-containing products * Pregnant or lactating * Post-menopausal or full hysterectomy

Design outcomes

Primary

Measure	Time frame	Description
Reduction in recurrence of hypertrophic scarring after scar revision surgery	9 months	To evaluate the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective revision of a hypertrophic abdominal scar

Secondary

Measure	Time frame	Description
Safety of RXI-109	9 months	To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after elective revision of a hypertrophic abdominal scar

Countries

Honduras, United States

Outcome results

None listed

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