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Prevalence and Clinical Severity of Cutaneous Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01510067
Recruitment Status : Recruiting
First Posted : January 13, 2012
Last Update Posted : October 26, 2016
Information provided by (Responsible Party):
VICTORIA WERTH, University of Pennsylvania

Brief Summary:
The Cutaneous Lupus Erythematosus (CLE) database, established in 2006, is a multi-site database between the University of Pennsylvania and the University of Texas Southwestern (UTSW).

Condition or disease
Cutaneous Lupus Erythematosus

Detailed Description:

The database has yielded valuable information and clinical insights into the pathophysiology, disease processes, treatments and quality of life associated with CLE. The CLE database incorporates the CLASI (Cutaneous Lupus Activity and Severity Index), a validated outcome measure of disease responsiveness in patients and other assessment tools, surveys and patient information to help validate the clinical course and quality of life of patients with CLE (cutaneous lupus erythematosus).

The CLE database has led to publication of significant studies on lupus and its clinical course, the effect of lupus on Quality of Life (QoL), including the effect of photosensitivity on QoL, and the effect of first line medications.

The CLE database is an ongoing resource that enables clinicians to evaluate the evolving clinical changes, treatment modalities and patient response to a challenging disease.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence and Clinical Severity of Cutaneous Lupus Erythematosus
Study Start Date : December 2006
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

Biospecimen Retention:   Samples With DNA
Blood, Skin Tissue Biopsies

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:   No
Sampling Method:   Probability Sample
Study Population
Subjects will be recruited from among the patients seen at the Autoimmune Skin Disease Clinic at the Hospital of the University of Pennsylvania and other collaborating centers.

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

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 identifier (NCT number): NCT01510067

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Contact: Victoria P Werth, MD 215-615-2940;
Contact: Joyce Okawa, R.N 215-615-2940

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United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Victoria P Werth, MD    215-898-0168      
United States, Texas
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Benjamin Chong         
Sponsors and Collaborators
University of Pennsylvania
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Principal Investigator: Victoria Werth, M.D. University of Pennsylvania

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Responsible Party: VICTORIA WERTH, Principal Investigator, University of Pennsylvania Identifier: NCT01510067     History of Changes
Other Study ID Numbers: 805758
First Posted: January 13, 2012    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by VICTORIA WERTH, University of Pennsylvania:
Lupus Erythematosus

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases