Back to resultsA Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery in Healthy Adults
Primary Purpose
Hypertrophic Scar
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
RXI-109
Placebo
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 in general good health
- Previous partial hysterectomy, Cesarean section or abdominoplasty surgery resulting in a transverse hypertrophic scar of ≥ 11 cm in length
- Scar to be revised must have been present for > 9 months
Exclusion Criteria:
- Use of tobacco or nicotine-containing products
- Pregnant or lactating
- Post-menopausal or full hysterectomy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
RXI-109
Placebo
Arm Description
Treatment with RXI-109 on one side of revised scar and a placebo comparator on the other side. Treatment to begin either immediately or 2 weeks following the scar revision surgery.
Treatment with RXI-109 on one side of revised scar and a placebo comparator on the other side. Treatment to begin either immediately or 2 weeks following the scar revision surgery.
Outcomes
Primary Outcome Measures
Reduction in recurrence of hypertrophic scarring after scar revision surgery
To evaluate the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective revision of a hypertrophic abdominal scar
Secondary Outcome Measures
Safety 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 abdominal scar
Full Information
NCT ID
NCT02030275
First Posted
January 6, 2014
Last Updated
June 20, 2016
Sponsor
RXi Pharmaceuticals, Corp.
1. Study Identification
Unique Protocol Identification Number
NCT02030275
Brief Title
A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery in Healthy Adults
Official Title
A Multi-Center, Prospective, Randomized, Double-Blind, Within-Subject Controlled, Phase 2a Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery on Transverse Hypertrophic Scars on the Lower Abdomen Resulting From Previous Surgeries in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
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 abdominal 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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RXI-109
Arm Type
Experimental
Arm Description
Treatment with RXI-109 on one side of revised scar and a placebo comparator on the other side. Treatment to begin either immediately or 2 weeks following the scar revision surgery.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Treatment with RXI-109 on one side of revised scar and a placebo comparator on the other side. Treatment to begin either immediately or 2 weeks following the scar revision surgery.
Intervention Type
Drug
Intervention Name(s)
RXI-109
Intervention Description
surgery.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
surgery.
Primary Outcome Measure Information:
Title
Reduction in recurrence of hypertrophic scarring after scar revision surgery
Description
To evaluate the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective revision of a hypertrophic abdominal scar
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Safety 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 abdominal 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 in general good health
Previous partial hysterectomy, Cesarean section or abdominoplasty surgery resulting in a transverse hypertrophic scar of ≥ 11 cm in length
Scar to be revised must have been present for > 9 months
Exclusion Criteria:
Use of tobacco or nicotine-containing products
Pregnant or lactating
Post-menopausal or full hysterectomy
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
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
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
City
San Pedro Sula
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 Scar Revision Surgery in Healthy Adults
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