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Interdisciplinary Study Group of Lupus Erythematosus (ISGLE)

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. Read our disclaimer for details. Identifier: NCT00420173
Recruitment Status : Completed
First Posted : January 9, 2007
Last Update Posted : December 12, 2013
Information provided by (Responsible Party):
Prof. Dr. Annegret Kuhn, Kuhn, Annegret

Brief Summary:
Cutaneous lupus erythematosus (CLE) is a disease with a wide spectrum of clinical manifestations and a variable prognosis. The aim of this study is to create a standardized evaluation of the different subtypes of this disease in order to receive an overview of the spectrum of clinical and laboratory features as well as the therapeutic strategies for patients with CLE.

Condition or disease Intervention/treatment
Cutaneous Lupus Erythematosus Procedure: Laboratory analysis

Detailed Description:
Methods: A core set questionnaire has been developed in the course of the "European Society of Cutaneous Lupus Erythematosus (EUSCLE)", and a total of 40 patients (32 females, 8 males) in two centres, Germany and Sweden, were included in this study. Results: CLE was diagnosed in 39 individuals (5 with acute CLE, 10 with subacute CLE, 13 with chronic CLE, and 18 with intermittent CLE) and one individual presented with a systemic manifestation of the disease. Furthermore, disease onset and duration as well as activity and damage of skin lesions using a modified CLASI were examined. Interestingly, 75% of the patients with CLE showed a positive history of photosensitivity, but only 62.5% exhibited characteristic lesions after standardized phototesting. Laboratory analysis revealed positive antinuclear antibodies in 50% of the patients, positive anti-Ro/SSA in 12 and positive anti-La/SSB antibodies in 8 cases. The predominantly used treatments included sunscreens (38 patients), topical steroids (31 patients), topical calcineurin inhibitors (12 patients), chloroquine (19 patients), hydroxychloroquine (11 patients), and systemic steroids (12 patients). Conclusions: The new core set questionnaire enables the clinician to characterize the different skin manifestations involved in CLE and to evaluate disease activity and reasonable treatment modalities. Furthermore, epidemiological data and laboratory features can be assessed for the various subtypes. In the future, this standardized evaluation might lead to the development of diagnostic guidelines and evidence based therapeutic strategies thus improving quality of care for patients with CLE.

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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Interdisciplinary Study Group of Lupus Erythematosus
Study Start Date : September 2004
Actual Primary Completion Date : July 2005
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Patients with CLE Procedure: Laboratory analysis
blood withdrawal

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:   Non-Probability Sample
Study Population
Patients with cutaneous lupus erythematosus

Inclusion Criteria:

  • cutaneous lupus erythematosus confirmed by histological analysis
  • photoprovocation-test performed in advance
  • written informed consent available prior to any procedures

Exclusion Criteria:

  • patients with conditions that are contrary to the above mentioned criteria

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): NCT00420173

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University of Muenster, Department of Dermatology
Muenster, NRW, Germany, 48149
Sponsors and Collaborators
European Society of Cutaneous Lupus Erythematosus e.V.
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Principal Investigator: Annegret Kuhn, MD University of Muenster
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Responsible Party: Prof. Dr. Annegret Kuhn, Professor, Kuhn, Annegret Identifier: NCT00420173    
Other Study ID Numbers: 2742-1
First Posted: January 9, 2007    Key Record Dates
Last Update Posted: December 12, 2013
Last Verified: December 2013
Keywords provided by Prof. Dr. Annegret Kuhn, Kuhn, Annegret:
cutaneous lupus erythematosus
standardized evaluation
core set questionnaire
epidemiological data
laboratory features
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases