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Completed

NCT Number: NCT01780077

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

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.

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Key information

Conditions

Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Scar Prevention

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RXI-109

Drug

Multiple intradermal injections of RXI-109 at incision sites

Placebo

Drug

Multiple intradermal injections of placebo at incision sites

Primary outcomes

  1. 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 outcomes

  1. 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 outcomes

  1. To assess the timeline and levels of biomarkers

    Time frame: 12 weeks

    Analysis of immunohistochemical analysis of biomarkers common to the scar formation pathway.

Sponsors and collaborators

Lead sponsor

RXi Pharmaceuticals, Corp.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 30, 2013
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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