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

Phase 2

Completed

• Conditions: Keloid
• Interventions: Drug: RXI-109; Drug: Placebo

• Registration Number: NCT02079168
• Lead Sponsor: RXi Pharmaceuticals, Corp.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-03
• Study First Submitted QC: 2014-03-04
• Study First Posted: 2014-03-05
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-13
• Last Update Posted: 2016-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	RXI-109	Treatment with RXI-109 at the site of one excised keloid and a placebo at the site of a second excised keloid. Dosing to begin at the time of surgery.
Cohort 1	Placebo	Treatment with RXI-109 at the site of one excised keloid and a placebo at the site of a second excised keloid. Dosing to begin at the time of surgery.
Cohort 2	RXI-109	Treatment with RXI-109 at the site of one excised keloid and a placebo at the site of a second excised keloid. Dosing to begin two weeks after surgery.
Cohort 2	Placebo	Treatment with RXI-109 at the site of one excised keloid and a placebo at the site of a second excised keloid. Dosing to begin two weeks after surgery.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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