European Society of Cutaneous Lupus Erythematosus (EUSCLE)
Recruitment status was Recruiting
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Purpose
Cutaneous lupus erythematosus (CLE) is a disease with a wide spectrum of clinical manifestations and a variable prognosis. The aim of the 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 |
|---|---|
|
Lupus Erythematosus, Cutaneous Lupus Erythematosus, Systemic |
Procedure: laboratory analysis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | European Society of Cutaneous Lupus Erythematosus |
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | December 2012 |
-
Procedure: laboratory analysis
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with systemic or cutaneous lupus erythematosus
Inclusion Criteria:
- systemic or cutaneous lupus erythematosus confirmed by histological analysis
- written informed consent available prior to any study-procedures
Exclusion Criteria:
- patients with conditions that are contrary to the above mentioned criteria
Contacts and Locations| Contact: Annegret Kuhn, MD | +49-251-8352210 | |
| Contact: Nikolaos Patsinakidis, MD | +49-251-8352163 |
| Germany | |
| University of Muenster, Department of Dermatology | Recruiting |
| Muenster, NRW, Germany, 48149 | |
| Contact: Annegret Kuhn, MD +49-251-8352210 | |
| Contact: Nikolaos Patsinakidis, MD +49-251-8352163 | |
| Principal Investigator: Annegret Kuhn, MD | |
| Principal Investigator: | Annegret Kuhn, MD | University of Muenster, Department of Dermatology |
More Information
No publications provided
| Responsible Party: | Annegret Kuhn, MD, European Society of Cutaneous Lupus Erythematosus |
| ClinicalTrials.gov Identifier: | NCT00420121 History of Changes |
| Other Study ID Numbers: | 2742-2 |
| Study First Received: | January 8, 2007 |
| Last Updated: | June 14, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Kuhn, Annegret:
|
standardized evaluation core set questionnaire epidemiological data laboratory analysis |
Additional relevant MeSH terms:
|
Lupus Erythematosus, Cutaneous Lupus Erythematosus, Systemic Connective Tissue Diseases |
Skin Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013