A Study to Evaluate the Effectiveness and Safety of RXI-109 on the Outcome of Keloid Excision Surgery in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-03-31

Brief Summary

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

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Detailed Description

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Conditions

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Keloid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Cohort 1

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.

Group Type EXPERIMENTAL

RXI-109

Intervention Type DRUG

Placebo

Intervention Type DRUG

Cohort 2

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.

Group Type EXPERIMENTAL

RXI-109

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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RXI-109

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.