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Sponsored by: |
Kuhn, Annegret |
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Information provided by: | Kuhn, Annegret |
ClinicalTrials.gov Identifier: | NCT00420173 |
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 | Intervention |
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Cutaneous Lupus Erythematosus |
Procedure: Laboratory analysis |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Interdisciplinary Study Group of Lupus Erythematosus |
Enrollment: | 45 |
Study Start Date: | September 2004 |
Study Completion Date: | June 2008 |
Groups/Cohorts | Assigned Interventions |
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A
Patients with CLE
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Procedure: Laboratory analysis
blood withdrawal
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients with cutaneous lupus erythematosus
Inclusion Criteria:
Exclusion Criteria:
Germany, NRW | |
Heinrich-Heine-University of Duesseldorf, Department of Dermatology | |
Duesseldorf, NRW, Germany, 40225 |
Principal Investigator: | Annegret Kuhn, MD | Heinrich-Heine-University |
Responsible Party: | European Society of Cutaneous Lupus Erythematosus ( Annegret Kuhn, MD ) |
Study ID Numbers: | 2742-1 |
Study First Received: | January 8, 2007 |
Last Updated: | September 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00420173 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
cutaneous lupus erythematosus standardized evaluation core set questionnaire epidemiological data laboratory features |
Cutaneous Lupus Erythematosus Autoimmune Diseases Skin Diseases Lupus Erythematosus, Systemic |
Lupus Lupus Erythematosus, Cutaneous Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Skin Diseases |
Lupus Erythematosus, Systemic Lupus Erythematosus, Cutaneous Connective Tissue Diseases |