Recruiting

Observational Study

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT01266915

Conditions

Lupus Erythematosus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Lupus Erythematosus

Study ID

NCT01266915

Start date

Jan, 2009

Status verified date

Nov, 2025

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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 measure

  • Genes [ Time Frame: 5 years ]
  • Proteins (ie. signaling proteins, autoantibodies) [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Benjamin Chong, MD, MSCS

214-648-3427skinlupus.registry@utsouthwestern.edu

Locations

University of Texas Southwestern Medical Center Dallas

Recruiting

Dallas, Texas, United States, 75390

Contacts

Benjamin F Chong, MD, MSCS

214-648-3427skinlupus.registry@utsouthwestern.edu

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Nov 26, 2025

Last verified

Nov, 2025

Keywords

  • SCLE
  • CLE
  • DLE

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2025-11-26.