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

Phase 2CompletedNCT02079168

RXi Pharmaceuticals, Corp.16 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Keloid

Interventions

RXI-109DRUG

PlaceboDRUG

Eligibility

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

Medical Language ↔ Plain English

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. Exclusion Criteria: * Use of tobacco or nicotine-containing products * Pregnant or lactating * Post-menopausal or full hysterectomy

Locations (3)

Unnamed facility

Miami, Florida, United States

Unnamed facility

St Louis, Missouri, United States

Unnamed facility

San Cristóbal, Dominican Republic

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

Safety of RXI-109

To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after elective excision of a keloid

Time frame: 6 months

Data from ClinicalTrials.gov

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