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

Primary Purpose

Hypertrophic Scar

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
RXI-109
Sponsored by
RXi Pharmaceuticals, Corp.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophic Scar focused on measuring Hypertrophic scar, Cicatrix, Scar prevention, Scar revision

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RXI-109

Arm Description

RXI-109 dosed at the site of the revised hypertrophic scar

Outcomes

Primary Outcome Measures

Reducing the recurrence of hypertrophic scar after scar revision surgery
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

Safety evaluation of RXI-109
To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after elective revision of a hypertrophic scar

Full Information

First Posted
September 16, 2014
Last Updated
February 21, 2018
Sponsor
RXi Pharmaceuticals, Corp.
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1. Study Identification

Unique Protocol Identification Number
NCT02246465
Brief Title
A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Revised Hypertrophic Scars
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RXi Pharmaceuticals, Corp.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Scar
Keywords
Hypertrophic scar, Cicatrix, Scar prevention, Scar revision

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RXI-109
Arm Type
Experimental
Arm Description
RXI-109 dosed at the site of the revised hypertrophic scar
Intervention Type
Drug
Intervention Name(s)
RXI-109
Primary Outcome Measure Information:
Title
Reducing the recurrence of hypertrophic scar after scar revision surgery
Description
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.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Safety evaluation of RXI-109
Description
To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after elective revision of a hypertrophic scar
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Pavco, PhD
Organizational Affiliation
RXi Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28028
Country
United States
City
San Pedro Sula
ZIP/Postal Code
21104
Country
Honduras

12. IPD Sharing Statement

Learn more about this trial

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

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