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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02246465
Recruitment Status : Active, not recruiting
First Posted : September 22, 2014
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertrophic Scar Drug: RXI-109 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2014
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246465


Locations
United States, California
Beverly Hills, California, United States, 90210
United States, Florida
Lake Worth, Florida, United States, 33461
United States, Illinois
Chicago, Illinois, United States, 60611
United States, Missouri
St. Louis, Missouri, United States, 63141
United States, North Carolina
Huntersville, North Carolina, United States, 28028
Honduras
San Pedro Sula, Honduras, 21104
Sponsors and Collaborators
RXi Pharmaceuticals, Corp.
Investigators
Study Director: Pamela Pavco, PhD RXi Pharmaceuticals
More Information

Responsible Party: RXi Pharmaceuticals, Corp.
ClinicalTrials.gov Identifier: NCT02246465     History of Changes
Other Study ID Numbers: RXI-109-1402
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: May 2016

Keywords provided by RXi Pharmaceuticals, Corp.:
Hypertrophic scar
Cicatrix
Scar prevention
Scar revision

Additional relevant MeSH terms:
Hypertrophy
Cicatrix, Hypertrophic
Pathological Conditions, Anatomical
Cicatrix
Fibrosis
Pathologic Processes