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
About this trial
This is an interventional treatment trial for Hypertrophic Scar focused on measuring Hypertrophic scar, Cicatrix, Scar prevention, Scar revision
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
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
NCT ID
NCT02246465
First Posted
September 16, 2014
Last Updated
February 21, 2018
Sponsor
RXi Pharmaceuticals, Corp.
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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