NCT02030275

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 abdominal scar.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2013

Geographic Reach
2 countries

5 active sites

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

November 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 21, 2016

Status Verified

June 1, 2016

Enrollment Period

2.6 years

First QC Date

January 6, 2014

Last Update Submit

June 20, 2016

Conditions

Hypertrophic Scar

Keywords

Hypertrophic scarCicatrixScar preventionScar revision

Outcome Measures

Primary Outcomes (1)

  • Reduction in recurrence of hypertrophic scarring after scar revision surgery

    To evaluate the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective revision of a hypertrophic abdominal scar

    9 months

Secondary Outcomes (1)

  • Safety of RXI-109

    9 months

Study Arms (2)

RXI-109

EXPERIMENTAL

Treatment with RXI-109 on one side of revised scar and a placebo comparator on the other side. Treatment to begin either immediately or 2 weeks following the scar revision surgery.

Drug: RXI-109

Placebo

PLACEBO COMPARATOR

Treatment with RXI-109 on one side of revised scar and a placebo comparator on the other side. Treatment to begin either immediately or 2 weeks following the scar revision surgery.

Drug: Placebo

Interventions

RXI-109DRUG

surgery.

RXI-109
PlaceboDRUG

surgery.

Placebo

Eligibility Criteria

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

You may qualify if:

  • Adults, 21-55 years of age in general good health
  • Previous partial hysterectomy, Cesarean section or abdominoplasty surgery resulting in a transverse hypertrophic scar of ≥ 11 cm in length
  • Scar to be revised must have been present for \> 9 months

You may not qualify if:

  • Use of tobacco or nicotine-containing products
  • Pregnant or lactating
  • Post-menopausal or full hysterectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

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, 28078, United States

Location

Unknown Facility

San Pedro Sula, 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
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2014

First Posted

January 8, 2014

Study Start

November 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 21, 2016

Record last verified: 2016-06

Locations

HO(1)US(4)