A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery in Healthy Adults
Overview
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.
Full Title of Study: “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
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: June 2016
Interventions
- Drug: RXI-109
- surgery.
- Drug: Placebo
- surgery.
Arms, Groups and Cohorts
- Experimental: 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 Comparator: 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.
Clinical Trial Outcome Measures
Primary Measures
- Reduction in recurrence of hypertrophic scarring after scar revision surgery
- Time Frame: 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 Measures
- Safety of RXI-109
- Time Frame: 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
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 21 Years
Maximum Age: 55 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- RXi Pharmaceuticals, Corp.
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Pamela Pavco, PhD, Study Director, RXi Pharmaceuticals
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