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OpenTrials
Completed

NCT Number: NCT02030275

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

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Key information

Conditions

Hypertrophic Scar Cicatrix Cicatrix, Hypertrophic Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

San Pedro Sula, Honduras

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RXI-109

Drug

surgery.

Placebo

Drug

surgery.

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

RXi Pharmaceuticals, Corp.

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 8, 2014
Registry last updated
Jun 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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