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Completed

NCT Number: NCT02079168

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

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

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Key information

Conditions

Keloid Cicatrix Collagen Diseases Connective Tissue Diseases Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Skin and Connective Tissue Diseases

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

San Cristobal, Dominican Republic

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RXI-109

Drug

Placebo

Drug

Primary outcomes

  1. Reduction in the recurrence of a keloid after keloid excision

    Time frame: 6 months

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

Secondary outcomes

  1. Safety of RXI-109

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

RXi Pharmaceuticals, Corp.

Industry

Registry information

Official study title

A Multi-Center, Prospective, Randomized, Single-Blind, Within-Subject Controlled, Phase 2a Study to Evaluate the Effectiveness and Safety of RXI-109 on the Outcome of Keloid Excision Surgery in Healthy Adults

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 5, 2014
Registry last updated
Jun 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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