Hypertrophic Scar Clinical Trial
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
Verified date | June 2016 |
Source | RXi Pharmaceuticals, Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 21 Years to 55 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
RXi Pharmaceuticals, Corp. |
United States, Honduras,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 9 months | No |
Secondary | 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 | 9 months | Yes |
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