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

Sponsor
RXi Pharmaceuticals, Corp. (Industry)
Overall Status
Completed
CT.gov ID
NCT01780077
Collaborator
(none)
15
Enrollment
2
Arms
23
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
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
Study Start Date :
Dec 1, 2012
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Nov 1, 2014

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. To assess the safety and tolerability of multiple intradermal administrations of RXI-109 [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

  1. To assess the effect of multiple intradermal administrations of RXI-109 on scar formation [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

  1. To assess the timeline and levels of biomarkers [12 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

No locations specified.

Sponsors and Collaborators

  • RXi Pharmaceuticals, Corp.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
RXi Pharmaceuticals, Corp.
ClinicalTrials.gov Identifier:
NCT01780077
Other Study ID Numbers:
  • RXI-109-1202
First Posted:
Jan 30, 2013
Last Update Posted:
Dec 3, 2014
Last Verified:
Dec 1, 2014
Keywords provided by RXi Pharmaceuticals, Corp.
Scar
Scar prevention
Fibrosis
Additional relevant MeSH terms:
Cicatrix

Study Results

No Results Posted as of Dec 3, 2014