NCT02246465

Brief Summary

The purpose of this study is to determine the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective revision of a pre-existing hypertrophic scar.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2014

Typical duration for phase_2

Geographic Reach
2 countries

6 active sites

Status
unknown

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

July 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

3.4 years

First QC Date

September 16, 2014

Last Update Submit

February 21, 2018

Conditions

Hypertrophic Scar

Keywords

Hypertrophic scarCicatrixScar preventionScar revision

Outcome Measures

Primary Outcomes (1)

  • Reducing the recurrence of hypertrophic scar after scar revision surgery

    To evaluate the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective scar revision surgery by review of photographic results and Patient and Observer Scar Assessment Scales.

    9 months

Secondary Outcomes (1)

  • Safety evaluation of RXI-109

    9 months

Study Arms (1)

RXI-109

EXPERIMENTAL

RXI-109 dosed at the site of the revised hypertrophic scar

Drug: RXI-109

Interventions

RXI-109DRUG
RXI-109

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults, 21-55 years of age
  • General good health
  • Previous surgery or injury resulting in a hypertrophic scar

You may not qualify if:

  • Scars on the face or front of neck may not be included in the trial
  • Use of tobacco or nicotine-containing products
  • Pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Beverly Hills, California, 90210, United States

Location

Unknown Facility

Lake Worth, Florida, 33461, United States

Location

Unknown Facility

Chicago, Illinois, 60611, United States

Location

Unknown Facility

St Louis, Missouri, 63141, United States

Location

Unknown Facility

Huntersville, North Carolina, 28028, United States

Location

Unknown Facility

San Pedro Sula, 21104, Honduras

Location

MeSH Terms

Conditions

Cicatrix, HypertrophicCicatrix

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pamela Pavco, PhD

    RXi Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2014

First Posted

September 22, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2017

Study Completion

March 1, 2018

Last Updated

February 23, 2018

Record last verified: 2018-02

Locations

HO(1)US(5)