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Evaluation of the Safety, Pharmacokinetics, and Preliminary Effect on Scar Formation by RXI-109

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: NCT01640912
Recruitment Status : Completed
First Posted : July 16, 2012
Last Update Posted : September 17, 2014
Sponsor:
Information provided by (Responsible Party):
RXi Pharmaceuticals, Corp.

Brief Summary:
The primary purpose of this study is to evaluate the safety and tolerability of a single intradermal administration of RXI-109 at small surgical incisions in the abdominal skin that will later be removed during an elective abdominoplasty. The effect of RXI-109 versus placebo on scarring at these incision sites will be evaluated visually and histologically.

Condition or disease Intervention/treatment Phase
Cicatrix Scar Prevention Drug: RXI-109 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1 Single Center, Randomized, Double-Blind, Ascending Dose, Within-Subject Controlled Study of RXI-109 for the Treatment of Incision Scars Made in the Pannus of Healthy Women Who Will Later Undergo Elective Abdominoplasty
Study Start Date : June 2012
Primary Completion Date : April 2014
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars
U.S. FDA Resources

Arm Intervention/treatment
Experimental: RXI-109 Drug: RXI-109
Single intradermal injection of RXI-109 at incision sites
Placebo Comparator: Placebo Drug: Placebo
Single intradermal injection of placebo at incision sites



Primary Outcome Measures :
  1. To assess the safety and tolerability of intradermal administration of RXI-109 [ Time Frame: 12 weeks ]
    Evaluate safety and tolerability of RXI-109 at site of intradermal injection. Examination and assessment of any and all local and systemic toxicities


Secondary Outcome Measures :
  1. To assess the effect of RXI-109 on scar formation following small surgical incisions [ Time Frame: 12 weeks ]
    Visual outcome and histology of scars will be assessed. Digital images of the RXI-109 and placebo-treated incisions/scars will be captured and assessed by a masked, independent, expert panel.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject must be a female in general good health with normal screening values
  • Subject must be a good surgical candidate for an elective abdominoplasty
  • Subjects must not be pregnant or lactating and utilize an effective method of contraception (if child-bearing potential exists)

Exclusion Criteria:

  • Currently pregnant or lactating
  • BMI greater than 35 at screening
  • Use of tobacco or nicotine-containing products within the month prior to enrollment and while on study
  • Any medical condition or current therapy which would make the subject unsuitable for this study in the opinion of the PI

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): NCT01640912


Locations
United States, Missouri
St. Louis, Missouri, United States, 63141
Sponsors and Collaborators
RXi Pharmaceuticals, Corp.

Responsible Party: RXi Pharmaceuticals, Corp.
ClinicalTrials.gov Identifier: NCT01640912     History of Changes
Other Study ID Numbers: RXI-109-1201
First Posted: July 16, 2012    Key Record Dates
Last Update Posted: September 17, 2014
Last Verified: September 2014

Keywords provided by RXi Pharmaceuticals, Corp.:
Scar
Scar prevention
Fibrosis

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes