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

Primary Purpose

Cicatrix, Scar Prevention

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
RXI-109
Placebo
Sponsored by
RXi Pharmaceuticals, Corp.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cicatrix focused on measuring Scar, Scar prevention, Fibrosis

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    RXI-109

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    To assess the safety and tolerability of multiple intradermal administrations of RXI-109
    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
    Assess visual outcome and histology of scars. Digital images of the RXI-109 and placebo-treated incisions/scars will be captured and scored.

    Full Information

    First Posted
    January 28, 2013
    Last Updated
    December 2, 2014
    Sponsor
    RXi Pharmaceuticals, Corp.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01780077
    Brief Title
    Evaluation of Safety, PK, and Preliminary Effects on Scar Formation of Multiple Intradermal Administrations of RXI-109
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2012 (undefined)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    November 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    RXi Pharmaceuticals, Corp.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cicatrix, Scar Prevention
    Keywords
    Scar, Scar prevention, Fibrosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    RXI-109
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    RXI-109
    Intervention Description
    Multiple intradermal injections of RXI-109 at incision sites
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Multiple intradermal injections of placebo at incision sites
    Primary Outcome Measure Information:
    Title
    To assess the safety and tolerability of multiple intradermal administrations of RXI-109
    Description
    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
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    To assess the effect of multiple intradermal administrations of RXI-109 on scar formation
    Description
    Assess visual outcome and histology of scars. Digital images of the RXI-109 and placebo-treated incisions/scars will be captured and scored.
    Time Frame
    12 weeks
    Other Pre-specified Outcome Measures:
    Title
    To assess the timeline and levels of biomarkers
    Description
    Analysis of immunohistochemical analysis of biomarkers common to the scar formation pathway.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

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

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