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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
RXi Pharmaceuticals, Corp.
ClinicalTrials.gov Identifier:
NCT01780077
First received: January 28, 2013
Last updated: January 6, 2014
Last verified: January 2014
  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
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, 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Analysis of immunohistochemical analysis of biomarkers common to the scar formation pathway.


Enrollment: 15
Study Start Date: December 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 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

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
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
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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: RXi Pharmaceuticals, Corp.
ClinicalTrials.gov Identifier: NCT01780077     History of Changes
Other Study ID Numbers: RXI-109-1202
Study First Received: January 28, 2013
Last Updated: January 6, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014