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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

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

Tracking Information
First Submitted Date  ICMJE January 6, 2014
First Posted Date  ICMJE January 8, 2014
Last Update Posted Date June 21, 2016
Study Start Date  ICMJE November 2013
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2014)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery in Healthy Adults
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypertrophic Scar
Intervention  ICMJE
  • Drug: RXI-109
    surgery.
  • Drug: Placebo
    surgery.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: RXI-109
  • 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 13, 2016)
25
Original Estimated Enrollment  ICMJE
 (submitted: January 6, 2014)
32
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Honduras,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02030275
Other Study ID Numbers  ICMJE RXI-109-1301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party RXi Pharmaceuticals, Corp.
Study Sponsor  ICMJE RXi Pharmaceuticals, Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pamela Pavco, PhD RXi Pharmaceuticals
PRS Account RXi Pharmaceuticals, Corp.
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP