Back to resultsEvaluation of the Safety, Pharmacokinetics, and Preliminary Effect on Scar Formation by RXI-109
Primary Purpose
Cicatrix, Scar Prevention
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
RXI-109
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cicatrix focused on measuring Scar, Scar prevention, Fibrosis
Eligibility Criteria
Inclusion Criteria:
- Subject must be a female in general good health with normal screening values
- Subject must be a good surgical candidate for an elective abdominoplasty
- Subjects must not be pregnant or lactating and utilize an effective method of contraception (if child-bearing potential exists)
Exclusion Criteria:
- Currently pregnant or lactating
- BMI greater than 35 at screening
- Use of tobacco or nicotine-containing products within the month prior to enrollment and while on study
- Any medical condition or current therapy which would make the subject unsuitable for this study in the opinion of the PI
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
RXI-109
Placebo
Arm Description
Outcomes
Primary Outcome Measures
To assess the safety and tolerability of intradermal administration of RXI-109
Evaluate safety and tolerability of RXI-109 at site of intradermal injection. Examination and assessment of any and all local and systemic toxicities
Secondary Outcome Measures
To assess the effect of RXI-109 on scar formation following small surgical incisions
Visual outcome and histology of scars will be assessed. Digital images of the RXI-109 and placebo-treated incisions/scars will be captured and assessed by a masked, independent, expert panel.
Full Information
NCT ID
NCT01640912
First Posted
July 12, 2012
Last Updated
September 16, 2014
Sponsor
RXi Pharmaceuticals, Corp.
1. Study Identification
Unique Protocol Identification Number
NCT01640912
Brief Title
Evaluation of the Safety, Pharmacokinetics, and Preliminary Effect on Scar Formation by RXI-109
Official Title
A Phase 1 Single Center, Randomized, Double-Blind, Ascending Dose, Within-Subject Controlled Study of RXI-109 for the Treatment of Incision Scars Made in the Pannus of Healthy Women Who Will Later Undergo Elective Abdominoplasty
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
May 2014 (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 primary purpose of this study is to evaluate the safety and tolerability of a single intradermal administration of RXI-109 at small surgical incisions in the abdominal skin that will later be removed during an elective abdominoplasty. The effect of RXI-109 versus placebo on scarring at these incision sites will be evaluated visually and histologically.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cicatrix, Scar Prevention
Keywords
Scar, Scar prevention, Fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RXI-109
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
RXI-109
Intervention Description
Single intradermal injection of RXI-109 at incision sites
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single intradermal injection of placebo at incision sites
Primary Outcome Measure Information:
Title
To assess the safety and tolerability of intradermal administration of RXI-109
Description
Evaluate safety and tolerability of RXI-109 at site of intradermal injection. Examination and assessment of any and all local and systemic toxicities
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
To assess the effect of RXI-109 on scar formation following small surgical incisions
Description
Visual outcome and histology of scars will be assessed. Digital images of the RXI-109 and placebo-treated incisions/scars will be captured and assessed by a masked, independent, expert panel.
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject must be a female in general good health with normal screening values
Subject must be a good surgical candidate for an elective abdominoplasty
Subjects must not be pregnant or lactating and utilize an effective method of contraception (if child-bearing potential exists)
Exclusion Criteria:
Currently pregnant or lactating
BMI greater than 35 at screening
Use of tobacco or nicotine-containing products within the month prior to enrollment and while on study
Any medical condition or current therapy which would make the subject unsuitable for this study in the opinion of the PI
Facility Information:
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Safety, Pharmacokinetics, and Preliminary Effect on Scar Formation by RXI-109
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