A Study to Evaluate the Effectiveness and Safety of RXI-109 on the Outcome of Keloid Excision Surgery in Healthy Adults

June 13, 2016 updated by: RXi Pharmaceuticals, Corp.

A Multi-Center, Prospective, Randomized, Single-Blind, Within-Subject Controlled, Phase 2a Study to Evaluate the Effectiveness and Safety of RXI-109 on the Outcome of Keloid Excision Surgery in Healthy Adults

To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

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

  • Dominican Republic
      • San Cristobal, Dominican Republic
  • United States
    • Florida
      • Miami, Florida, United States, 33137
    • Missouri
      • St. Louis, Missouri, United States, 63141

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.
  • Two keloids of approximately similar size and anatomical location on the earlobe, neck, or torso.
  • Keloids to be excised must have been present for > 1 year.

Exclusion Criteria:

  • Use of tobacco or nicotine-containing products
  • Pregnant or lactating
  • Post-menopausal or full hysterectomy

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Treatment with RXI-109 at the site of one excised keloid and a placebo at the site of a second excised keloid. Dosing to begin at the time of surgery.
Drug: Placebo
Drug: RXI-109
Experimental: Cohort 2
Treatment with RXI-109 at the site of one excised keloid and a placebo at the site of a second excised keloid. Dosing to begin two weeks after surgery.
Drug: Placebo
Drug: RXI-109

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in the recurrence of a keloid after keloid excision
Time Frame: 6 months
To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of RXI-109
Time Frame: 6 months
To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after elective excision of a keloid
6 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

March 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

March 3, 2014

First Submitted That Met QC Criteria

March 4, 2014

First Posted (Estimate)

March 5, 2014

Study Record Updates

Last Update Posted (Estimate)

June 14, 2016

Last Update Submitted That Met QC Criteria

June 13, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RXI-109-1401

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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