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Cutaneous Lupus Registry

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ClinicalTrials.gov Identifier: NCT01266915
Recruitment Status : Recruiting
First Posted : December 24, 2010
Last Update Posted : November 4, 2022
Information provided by (Responsible Party):
Ben Chong, University of Texas Southwestern Medical Center

Brief Summary:

Approximately 1.4 million individuals in the United States have systemic lupus erythematosus, and about 85% of these individuals develop skin lesions at some point of their disease. Cutaneous lupus erythematosus represents the skin manifestations of systemic lupus erythematosus, and can appear in people with or without systemic lupus. It is a mentally, physically, and emotionally debilitating disease that affects both the quality of life and social well-being of those affected.

The cause of cutaneous lupus is not completely understood, but likely includes multiple factors from our genes and the environment. Multiple genetic studies with small numbers of cutaneous lupus patients have been performed to determine which genes are associated with cutaneous lupus. This study aims to accumulate even larger numbers of patients to confidently identify genes and the proteins they encode that could contribute greatly to the formation of cutaneous lupus. The discovery of these genes and proteins would help not only uncover how cutaneous lupus forms, but also improve our abilities to diagnose this disease and predict its course, and stimulate new drug development.

Condition or disease
Lupus Erythematosus

Detailed Description:

The purpose of this study is to create a national registry of patients with cutaneous lupus patients in order to address many unknown questions about this disease. Specifically, we are interested in better understanding the causes of cutaneous lupus and improving our methods of diagnosis, prognosis, and management of this disease. We plan to use information from all patient sources, including medical histories, clinical information, laboratory data, and blood and skin samples in order to answer these questions.

Each study patient will be asked to complete a series of questionnaires, which, for example, will ask about cutaneous and/or systemic lupus history, past medical history, family history, quality of life, and sun protective habits. Patients will be also asked to donate blood and skin samples and undergo digital photography of affected areas. No treatments will be administered as part of this study, but all participants will be notified of clinical trials being conducted at UT Southwestern. This study is for the purpose of data collection only. Patients will be asked to be followed on an annual basis for five years.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Studies on Cutaneous Lupus
Study Start Date : January 2009
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Control group
Normal disease free (non lupus) subjects
Diseased Control
Diseased group 1
Those subjects with systemic lupus erythematosus.
Diseased group 2
Subjects diagnosed with cutaneous lupus.

Primary Outcome Measures :
  1. Genes [ Time Frame: 5 years ]
  2. Proteins (ie. signaling proteins, autoantibodies) [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Subjects diagnosed with Lupus Erythematosus

Inclusion Criteria:

  • Diagnosed with cutaneous lupus erythematosus and/or systemic lupus erythematosus by clinical, laboratory, and histopathological findings
  • Ability to speak and read English or Spanish at a 6th grade reading level (a translator will be available with additional consent forms in Spanish)
  • Ability to give written informed consent

Exclusion Criteria:

  • Less than 18 years of age, since the characteristics of the disease in these subjects could be very different
  • Due to a medication, in which its discontinuation results in the resolution of cutaneous lupus, since the characteristics of the disease in these subjects could be very different
  • Medical conditions who do not warrant a skin biopsy
  • Unable to give written, informed consent or undergo a skin biopsy and/or venipuncture for any other reason

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01266915

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Contact: Benjamin Chong, MD, MSCS 214-648-3427 skinlupus.registry@utsouthwestern.edu

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United States, Texas
University of Texas Southwestern Medical Center Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Benjamin F Chong, MD, MSCS    214-648-3427    skinlupus.registry@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
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Responsible Party: Ben Chong, Associate Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01266915    
Other Study ID Numbers: STU 112008-008
First Posted: December 24, 2010    Key Record Dates
Last Update Posted: November 4, 2022
Last Verified: November 2022
Keywords provided by Ben Chong, University of Texas Southwestern Medical Center: