A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Revised Hypertrophic Scars

February 21, 2018 updated by: RXi Pharmaceuticals, Corp.

An Open-Label, Multi-Center, Prospective, Within-Subject Controlled, Phase 2a Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery for Hypertrophic Scars 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 scar.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Honduras
      • San Pedro Sula, Honduras, 21104
  • United States
    • California
      • Beverly Hills, California, United States, 90210
    • Florida
      • Lake Worth, Florida, United States, 33461
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Missouri
      • Saint Louis, Missouri, United States, 63141
    • North Carolina
      • Huntersville, North Carolina, United States, 28028

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults, 21-55 years of age
  • General good health
  • Previous surgery or injury resulting in a hypertrophic scar

Exclusion Criteria:

  • Scars on the face or front of neck may not be included in the trial
  • Use of tobacco or nicotine-containing products
  • Pregnant or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RXI-109
RXI-109 dosed at the site of the revised hypertrophic scar
Drug: RXI-109

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reducing the recurrence of hypertrophic scar 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 scar revision surgery by review of photographic results and Patient and Observer Scar Assessment Scales.
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety evaluation 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 scar
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RXi Pharmaceuticals, Corp.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

September 16, 2014

First Submitted That Met QC Criteria

September 18, 2014

First Posted (Estimate)

September 22, 2014

Study Record Updates

Last Update Posted (Actual)

February 23, 2018

Last Update Submitted That Met QC Criteria

February 21, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RXI-109-1402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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