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

Phase 2

• Conditions: Hypertrophic Scar
• Interventions: Drug: RXI-109

• Registration Number: NCT02246465
• Lead Sponsor: RXi Pharmaceuticals, Corp.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-09-16
• Study First Submitted QC: 2014-09-18
• Study First Posted: 2014-09-22
• Primary Completion: 2017-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-21
• Last Update Posted: 2018-02-23
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RXI-109	RXI-109	RXI-109 dosed at the site of the revised hypertrophic scar

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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