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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

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ClinicalTrials.gov Identifier: NCT02030275
Recruitment Status : Completed
First Posted : January 8, 2014
Last Update Posted : June 21, 2016
Sponsor:
Information provided by (Responsible Party):
RXi Pharmaceuticals, Corp.

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 abdominal scar.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : November 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Experimental: RXI-109
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.
Drug: RXI-109
surgery.

Placebo Comparator: Placebo
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.
Drug: Placebo
surgery.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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 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

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): NCT02030275


Locations
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, 28078
Honduras
San Pedro Sula, Honduras
Sponsors and Collaborators
RXi Pharmaceuticals, Corp.
Investigators
Study Director: Pamela Pavco, PhD RXi Pharmaceuticals

Responsible Party: RXi Pharmaceuticals, Corp.
ClinicalTrials.gov Identifier: NCT02030275     History of Changes
Other Study ID Numbers: RXI-109-1301
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 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