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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
RXi Pharmaceuticals, Corp.
ClinicalTrials.gov Identifier:
NCT01640912
First received: July 12, 2012
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01640912

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

No publications provided

Responsible Party: RXi Pharmaceuticals, Corp.
ClinicalTrials.gov Identifier: NCT01640912     History of Changes
Other Study ID Numbers: RXI-109-1201
Study First Received: July 12, 2012
Last Updated: September 16, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014