A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery in Healthy Adults

RXi Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hypertrophic Scar

Treatments: Drug: Placebo; Drug: RXI-109

Study type: Interventional

Funder types: Industry

Identifiers

NCT02030275

RXI-109-1301

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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25 participants in 2 patient groups, including a placebo group

RXI-109

Experimental group

Description:

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.

Treatment:

Drug: RXI-109

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo