A Non-Interventional Pilot Study Assessing Whether Lysyl Oxidase-like 2 (LOXL2) is Present in Subjects With Scleroderma

To treat patients with scleroderma by blocking the expression of LOXL2. The investigators first need to confirm (through observation) that LOXL2 is overexpressed in disease.

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Key information

Conditions

Limited Scleroderma Connective Tissue Diseases Diffuse Scleroderma Pathologic Processes Pathological Conditions, Signs and Symptoms Scleroderma, Diffuse Scleroderma, Limited Scleroderma, Systemic Sclerosis Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Vincent's Centre for Applied Medical Research

Darlinghurst, New South Wales, 2010, Australia

About this study

Scleroderma is a chronic skin-hardening disease. There are two types of scleroderma. The first type is called limited cutaneous scleroderma, where disrupted blood flow causes skin discoloration and sometimes patients experience high blood pressure in their arteries. The second type is called diffuse cutaneous scleroderma and it is much more aggressive, affecting a larger area of skin causing organ damage. This study will determine if the disease is associated with an elevated expression of LOXL2 levels in tissue samples from patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Over 18 years of age
Documented diagnosis of scleroderma
Willing and able to provide written informed consent

Exclusion criteria

Use of experimental therapies within 28 days prior to Screening.
Aspirin use > 81 mg daily within 1 week prior to Screening.
Any lab abnormality or concurrent medical condition that, in the opinion of the investigator would make the patient ineligible for the study

Treatment and study plan

Primary outcomes

Summarized the number and percentage of subjects with elevated LOXL2 levels

Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Jun 19, 2013
Registry last updated: Apr 17, 2014

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

Published trials that share one or more normalized conditions with this study.

Completed