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Evaluation of Safety, PK, and Preliminary Effects on Scar Formation of Multiple Intradermal Administrations of RXI-109

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01780077
First Posted: January 30, 2013
Last Update Posted: December 3, 2014
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.
Information provided by (Responsible Party):
RXi Pharmaceuticals, Corp.
  Purpose
The purpose of this trial is to evaluate the safety and tolerability of multiple (3) intradermal doses of RXI-109 at small surgical incisions in the abdominal skin of healthy volunteers. The effect of RXI-109 versus placebo on scarring at these incision sites will be evaluated visually, histologically, and by biomarker analysis.

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, Multi-Dose, Within-Subject Controlled Study of RXI-109 for the Treatment of Incision Scars Made in the Abdominal Skin of Healthy Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To assess the safety and tolerability of multiple intradermal administrations of RXI-109 [ Time Frame: 12 weeks ]
    Evaluate safety and tolerability of multiple administrations of RXI-109 at the site of intradermal injection. Examine and assess any and all local and systemic toxicities


Secondary Outcome Measures:
  • To assess the effect of multiple intradermal administrations of RXI-109 on scar formation [ Time Frame: 12 weeks ]
    Assess visual outcome and histology of scars. Digital images of the RXI-109 and placebo-treated incisions/scars will be captured and scored.


Other Outcome Measures:
  • To assess the timeline and levels of biomarkers [ Time Frame: 12 weeks ]
    Analysis of immunohistochemical analysis of biomarkers common to the scar formation pathway.


Enrollment: 15
Study Start Date: December 2012
Study Completion Date: November 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RXI-109 Drug: RXI-109
Multiple intradermal injections of RXI-109 at incision sites
Drug: Placebo
Multiple intradermal injections of placebo at incision sites
Placebo Comparator: Placebo Drug: RXI-109
Multiple intradermal injections of RXI-109 at incision sites
Drug: Placebo
Multiple intradermal injections of placebo at incision sites

  Eligibility

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:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and females, 21-50 years of age
  • General good health; if female not pregnant or lactating
  • Phototype 3 and above based on the Fitzpatrick scale.

Exclusion Criteria:

  • Pregnant or lactating
  • Use of tobacco or nicotine-containing products within 1 month prior to enrollment and while on study
  • Type 1 or 2 diabetes mellitus
  • A history or presence of any medical condition or therapy that would make the subject an unsafe candidate in the opinion of the investigator
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: RXi Pharmaceuticals, Corp.
ClinicalTrials.gov Identifier: NCT01780077     History of Changes
Other Study ID Numbers: RXI-109-1202
First Submitted: January 28, 2013
First Posted: January 30, 2013
Last Update Posted: December 3, 2014
Last Verified: December 2014

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

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes