NCT02079168

Brief Summary

To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2014

Geographic Reach
2 countries

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

June 14, 2016

Status Verified

June 1, 2016

Enrollment Period

2 years

First QC Date

March 3, 2014

Last Update Submit

June 13, 2016

Conditions

Keloid

Keywords

KeloidCicatrixKeloid preventionKeloid revision/excisionKeloidectomy

Outcome Measures

Primary Outcomes (1)

  • Reduction in the recurrence of a keloid after keloid excision

    To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision

    6 months

Secondary Outcomes (1)

  • Safety of RXI-109

    6 months

Study Arms (2)

Cohort 1

EXPERIMENTAL

Treatment with RXI-109 at the site of one excised keloid and a placebo at the site of a second excised keloid. Dosing to begin at the time of surgery.

Drug: RXI-109Drug: Placebo

Cohort 2

EXPERIMENTAL

Treatment with RXI-109 at the site of one excised keloid and a placebo at the site of a second excised keloid. Dosing to begin two weeks after surgery.

Drug: RXI-109Drug: Placebo

Interventions

RXI-109DRUG
Cohort 1Cohort 2
PlaceboDRUG
Cohort 1Cohort 2

Eligibility Criteria

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

You may qualify if:

  • Adults, 21-55 years of age.
  • Two keloids of approximately similar size and anatomical location on the earlobe, neck, or torso.
  • Keloids to be excised must have been present for \> 1 year.

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 (3)

Unknown Facility

Miami, Florida, 33137, United States

Location

Unknown Facility

St Louis, Missouri, 63141, United States

Location

Unknown Facility

San Cristóbal, Dominican Republic

Location

MeSH Terms

Conditions

KeloidCicatrix

Condition Hierarchy (Ancestors)

Collagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesFibrosisPathologic 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
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2014

First Posted

March 5, 2014

Study Start

March 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

June 14, 2016

Record last verified: 2016-06

Locations

US(2)DO(1)