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

This study has been completed.
Information provided by (Responsible Party):
RXi Pharmaceuticals, Corp. Identifier:
First received: July 12, 2012
Last updated: September 16, 2014
Last verified: September 2014
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 Intervention Phase
Cicatrix Scar Prevention Drug: RXI-109 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by RXi Pharmaceuticals, Corp.:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 15
Study Start Date: June 2012
Study Completion Date: May 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01640912

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

Responsible Party: RXi Pharmaceuticals, Corp. Identifier: NCT01640912     History of Changes
Other Study ID Numbers: RXI-109-1201
Study First Received: July 12, 2012
Last Updated: September 16, 2014

Keywords provided by RXi Pharmaceuticals, Corp.:
Scar prevention

Additional relevant MeSH terms:
Pathologic Processes processed this record on September 21, 2017