A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery in Healthy Adults

NCT ID: NCT02030275

Last Updated: 2016-06-21

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

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-06-30

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 abdominal scar.

Detailed Description

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Conditions

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Hypertrophic Scar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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RXI-109

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.

Group Type EXPERIMENTAL

RXI-109

Intervention Type DRUG

surgery.

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

surgery.

Interventions

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RXI-109

surgery.

Intervention Type DRUG

Placebo

surgery.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Use of tobacco or nicotine-containing products
* Pregnant or lactating
* Post-menopausal or full hysterectomy
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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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-109-1301

Identifier Type: -

Identifier Source: org_study_id

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