A Study to Evaluate the Effectiveness and Safety of RXI-109 on the Outcome of Keloid Excision Surgery in Healthy Adults

A Multi-Center, Prospective, Randomized, Single-Blind, Within-Subject Controlled, Phase 2a Study to Evaluate the Effectiveness and Safety of RXI-109 on the Outcome of Keloid Excision Surgery in Healthy Adults

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02079168

Enrollment

Registered

2014-03-05

Start date

2014-03-31

Completion date

2016-03-31

Last updated

2016-06-14

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

Conditions

Keloid

Keywords

Keloid, Cicatrix, Keloid prevention, Keloid revision/excision, Keloidectomy

Brief summary

To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision.

Interventions

DRUGRXI-109

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Adults, 21-55 years of age. * Two keloids of approximately similar size and anatomical location on the earlobe, neck, or torso. * Keloids to be excised must have been present for \> 1 year.

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 the recurrence of a keloid after keloid excision	6 months	To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision

Secondary

Measure	Time frame	Description
Safety of RXI-109	6 months	To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after elective excision of a keloid

Countries

Dominican Republic, United States

Outcome results

None listed

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