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

R

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

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

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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