Back to resultsA Study to Evaluate the Effectiveness and Safety of RXI-109 on the Outcome of Keloid Excision Surgery in Healthy Adults
Primary Purpose
Keloid
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 Keloid focused on measuring Keloid, Cicatrix, Keloid prevention, Keloid revision/excision, Keloidectomy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Reduction in the recurrence of a keloid after keloid excision
To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision
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 excision of a keloid
Full Information
NCT ID
NCT02079168
First Posted
March 3, 2014
Last Updated
June 13, 2016
Sponsor
RXi Pharmaceuticals, Corp.
1. Study Identification
Unique Protocol Identification Number
NCT02079168
Brief Title
A Study to Evaluate the Effectiveness and Safety of RXI-109 on the Outcome of Keloid Excision Surgery in Healthy Adults
Official Title
A Multi-Center, Prospective, Randomized, Single-Blind, Within-Subject Controlled, Phase 2a Study to Evaluate the Effectiveness and Safety of RXI-109 on the Outcome of Keloid Excision Surgery in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 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
To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid
Keywords
Keloid, Cicatrix, Keloid prevention, Keloid revision/excision, Keloidectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
RXI-109
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Reduction in the recurrence of a keloid after keloid excision
Description
To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision
Time Frame
6 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 excision of a keloid
Time Frame
6 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.
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
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
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
San Cristobal
Country
Dominican Republic
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Effectiveness and Safety of RXI-109 on the Outcome of Keloid Excision Surgery in Healthy Adults
We'll reach out to this number within 24 hrs