Understanding the prevalence and severity of cutaneous lupus erythematosus
Official title: Prevalence and Clinical Severity of Cutaneous Lupus Erythematosus
Run by University of Pennsylvania · NCT01510067 · Data updated 2026-11-12
This study is trying to understand how common and severe skin lupus is by collecting information from patients to help improve their treatment and quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 700 (estimated) |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 2 sites (Philadelphia, Pennsylvania and 1 other locations) |
| Status | Recruiting |
| Started | December 2006 |
| Main results expected | January 2, 2030 |
| Study ends | January 2, 2030 |
| Registry record updated | March 30, 2026 |
| Trial ID | NCT01510067 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who have been diagnosed with cutaneous lupus erythematosus or systemic lupus erythematosus.
✕Probably not a fit
Patients who do not meet the criteria for having CLE or are under 18 years old may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on the prevalence and clinical severity of cutaneous lupus erythematosus (CLE) through a multi-site database established between the University of Pennsylvania and the University of Texas Southwestern. The database collects valuable information on the disease's pathophysiology, treatment responses, and quality of life impacts for patients with CLE. Utilizing the Cutaneous Lupus Activity and Severity Index (CLASI) and other assessment tools, the study aims to validate clinical courses and patient experiences over time. The ongoing resource allows clinicians to track evolving clinical changes and treatment modalities in this challenging condition.
Why it matters
Potential benefit: If successful, this study could enhance understanding of CLE, leading to improved treatment strategies and better quality of life for patients.
How similar studies have gone: Other studies utilizing similar observational approaches have shown success in understanding lupus and its impacts, indicating that this methodology is both tested and valuable.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects who meet the criteria for having CLE, using the Gilliam classifications, and/or a diagnosis of systemic lupus erythematosus (SLE), using the American Rheumatism Association/American College of Rheumatology criteria. Subjects must be 18 years or older. Exclusion Criteria: * All subjects who do not meet the criteria for having CLE. Subjects who meet the criteria for CLE but who are not yet 18 years old
Where it's running
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Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States Recruiting -
University of Texas Southwestern
Dallas, Texas, United States Recruiting
Study contacts
- Principal investigator: Victoria Werth, M.D. — University of Pennsylvania
- Study coordinator: Victoria P Werth, MD
- Email: werth@pennmedicine.upenn.edu
- Phone: 215-615-2940
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Afimetoran in Adults With Cutaneous Lupus Erythematosus
This study tests whether the oral medicine afimetoran helps skin lupus in adults who did not respond to antimalarials, by comparing it with a placebo over 24 weeks followed by all participants receiving the drug for 28 more weeks.
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Long-Term Extension of enpatoran for cutaneous lupus symptoms
This extension study tests whether continuing enpatoran is safe and helpful for people with skin lupus who completed previous trials, for up to about two years.
-
Quinacrine for Cutaneous Lupus Erythematosus
This study tests whether quinacrine can help adults with active cutaneous lupus erythematosus when compared to placebo.
-
S-4321 in adults with autoimmune or immune-mediated diseases
This study tests S-4321 in adults with autoimmune conditions to see if it is safe and tolerable and to gather early data on how the drug behaves in the body and its initial effects on disease markers.
-
ICP-488 for Cutaneous Lupus Erythematosus: a 2nd phase study to test safety and efficacy
This phase II study tests ICP-488 versus placebo in adults with cutaneous lupus erythematosus to see if it helps skin symptoms while checking safety.
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Enpatoran for adults with skin lupus, with or without systemic disease
This 24-week test will see if enpatoran tablets reduce active skin lesions in adults with cutaneous lupus, with or without systemic lupus.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.