A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Revised Hypertrophic Scars

An Open-Label, Multi-Center, Prospective, Within-Subject Controlled, Phase 2a Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery for Hypertrophic Scars in Healthy Adults

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02246465

Enrollment

Registered

2014-09-22

Start date

2014-07-31

Completion date

2018-03-31

Last updated

2018-02-23

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 scar.

Interventions

DRUGRXI-109

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Adults, 21-55 years of age * General good health * Previous surgery or injury resulting in a hypertrophic scar

Exclusion criteria

* Scars on the face or front of neck may not be included in the trial * Use of tobacco or nicotine-containing products * Pregnant or lactating

Design outcomes

Primary

Measure	Time frame	Description
Reducing the recurrence of hypertrophic scar after scar revision surgery	9 months	To evaluate the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective scar revision surgery by review of photographic results and Patient and Observer Scar Assessment Scales.

Secondary

Measure	Time frame	Description
Safety evaluation 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 scar

Countries

Honduras, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026