NCT01780077

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

1.5 years

First QC Date

January 28, 2013

Last Update Submit

December 2, 2014

Conditions

CicatrixScar Prevention

Keywords

ScarScar preventionFibrosis

Outcome Measures

Primary Outcomes (1)

  • 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

    12 weeks

Secondary Outcomes (1)

  • To assess the effect of multiple intradermal administrations of RXI-109 on scar formation

    12 weeks

Other Outcomes (1)

  • To assess the timeline and levels of biomarkers

    12 weeks

Study Arms (2)

RXI-109

EXPERIMENTAL
Drug: RXI-109Drug: Placebo

Placebo

PLACEBO COMPARATOR
Drug: RXI-109Drug: Placebo

Interventions

RXI-109DRUG

Multiple intradermal injections of RXI-109 at incision sites

PlaceboRXI-109
PlaceboDRUG

Multiple intradermal injections of placebo at incision sites

PlaceboRXI-109

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

CicatrixFibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2013

First Posted

January 30, 2013

Study Start

December 1, 2012

Primary Completion

June 1, 2014

Study Completion

November 1, 2014

Last Updated

December 3, 2014

Record last verified: 2014-12