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

RXi Pharmaceuticals, Corp.40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertrophic Scar

Interventions

RXI-109DRUG

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (6)

Unnamed facility

Beverly Hills, California, United States

Unnamed facility

Lake Worth, Florida, United States

Unnamed facility

Chicago, Illinois, United States

Unnamed facility

St Louis, Missouri, United States

Outcomes

Primary Outcomes

Reducing the recurrence of hypertrophic scar after scar revision surgery

To evaluate the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective scar revision surgery by review of photographic results and Patient and Observer Scar Assessment Scales.

Time frame: 9 months

Secondary Outcomes

Safety evaluation of RXI-109

To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after elective revision of a hypertrophic scar

Time frame: 9 months

Data from ClinicalTrials.gov

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