A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery in Healthy Adults
- Registration Number
- NCT02030275
- Lead Sponsor
- RXi Pharmaceuticals, Corp.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RXI-109 RXI-109 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. Placebo Placebo 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.
- Primary Outcome Measures
Name Time Method Reduction in recurrence of hypertrophic scarring after scar revision surgery 9 months 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
Name Time Method Safety of RXI-109 9 months To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after elective revision of a hypertrophic abdominal scar