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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
RXi Pharmaceuticals, Corp.
ClinicalTrials.gov Identifier:
NCT01640912
First received: July 12, 2012
Last updated: January 6, 2014
Last verified: January 2014

July 12, 2012
January 6, 2014
June 2012
January 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01640912 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Evaluation of the Safety, Pharmacokinetics, and Preliminary Effect on Scar Formation by RXI-109
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Cicatrix
  • Scar Prevention
  • Drug: RXI-109
    Single intradermal injection of RXI-109 at incision sites
  • Drug: Placebo
    Single intradermal injection of placebo at incision sites
  • Experimental: RXI-109
    Intervention: Drug: RXI-109
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
February 2014
January 2014   (final data collection date for primary outcome measure)

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
Female
21 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01640912
RXI-109-1201
Yes
RXi Pharmaceuticals, Corp.
RXi Pharmaceuticals, Corp.
Not Provided
Not Provided
RXi Pharmaceuticals, Corp.
January 2014

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