Interdisciplinary Study Group of Lupus Erythematosus (ISGLE)

This study has been completed.
Sponsor:
Information provided by:
Kuhn, Annegret
ClinicalTrials.gov Identifier:
NCT00420173
First received: January 8, 2007
Last updated: June 14, 2011
Last verified: June 2011

January 8, 2007
June 14, 2011
September 2004
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Complete list of historical versions of study NCT00420173 on ClinicalTrials.gov Archive Site
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Interdisciplinary Study Group of Lupus Erythematosus (ISGLE)
Interdisciplinary Study Group of Lupus Erythematosus

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients with cutaneous lupus erythematosus

Cutaneous Lupus Erythematosus
Procedure: Laboratory analysis
blood withdrawal
Patients with CLE
Intervention: Procedure: Laboratory analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
June 2008
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00420173
2742-1
No
Annegret Kuhn, MD, European Society of Cutaneous Lupus Erythematosus
Kuhn, Annegret
Not Provided
Principal Investigator: Annegret Kuhn, MD University of Muenster
Kuhn, Annegret
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP