Lupus ErythematosusNCT01266915
Cutaneous Lupus Registry
An observational study of Lupus Erythematosus, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lupus Erythematosus
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects diagnosed with Lupus Erythematosus
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center Dallas
Dallas, Texas, 75390
Benjamin F Chong, MD, MSCS, 214-648-3427, skinlupus.registry@utsouthwestern.edu
About this study
Official title: Molecular Studies on Cutaneous Lupus
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.
Read the 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.
- Conditions
- Lupus Erythematosus
- Keywords
- SCLE, CLE, DLE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Normal disease free (non lupus) subjects | |
| Diseased Control | Not described | |
| Diseased group 1 | Those subjects with systemic lupus erythematosus. | |
| Diseased group 2 | Subjects diagnosed with cutaneous lupus. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genes
Measured: 5 years
Proteins (ie. signaling proteins, autoantibodies)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study startJan 2009
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben Chong, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266915
- Sponsor's protocol ID
- STU 112008-008
- Status last verified
- Nov 2025
- First submitted
- 23 Dec 2010
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Studies on Cutaneous Lupus
- ClinicalTrials.gov ID
- NCT01266915
- Acronym / sponsor ID
- STU 112008-008
- Conditions
- Lupus Erythematosus
- Keywords
- SCLE, CLE, DLE
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 24 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects diagnosed with Lupus Erythematosus
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genes
Time frame: 5 years
Proteins (ie. signaling proteins, autoantibodies)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Erythematosus, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Chong, MD, MSCS (214-648-3427, skinlupus.registry@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genes (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.