A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Revised Hypertrophic Scars

NCT ID: NCT02246465

Last Updated: 2018-02-23

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2018-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertrophic Scar

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RXI-109

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

Group Type EXPERIMENTAL

RXI-109

Intervention Type DRUG

Interventions

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RXI-109

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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RXi Pharmaceuticals, Corp.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pamela Pavco, PhD

Role: STUDY_DIRECTOR

RXi Pharmaceuticals

Locations

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Beverly Hills, California, United States

Site Status

Lake Worth, Florida, United States

Site Status

Chicago, Illinois, United States

Site Status

St Louis, Missouri, United States

Site Status

Huntersville, North Carolina, United States

Site Status

San Pedro Sula, , Honduras

Site Status

Countries

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United States Honduras

Other Identifiers

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RXI-109-1402

Identifier Type: -

Identifier Source: org_study_id

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