A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery in Healthy Adults
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 21 - 55 |
| Updated: | 6/22/2016 |
| Start Date: | November 2013 |
| End Date: | June 2016 |
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
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.
recurrence of hypertrophic scar formation following elective revision of a pre-existing
hypertrophic abdominal scar.
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
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