Interdisciplinary Study Group of Lupus Erythematosus (ISGLE)

This study has been completed.
Information provided by (Responsible Party):
Prof. Dr. Annegret Kuhn, Kuhn, Annegret Identifier:
First received: January 8, 2007
Last updated: December 11, 2013
Last verified: December 2013
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
Cutaneous Lupus Erythematosus
Procedure: Laboratory analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Interdisciplinary Study Group of Lupus Erythematosus

Resource links provided by NLM:

Further study details as provided by European Society of Cutaneous Lupus Erythematosus e.V.:

Enrollment: 45
Study Start Date: September 2004
Study Completion Date: June 2008
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with CLE Procedure: Laboratory analysis
blood withdrawal

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00420173

University of Muenster, Department of Dermatology
Muenster, NRW, Germany, 48149
Sponsors and Collaborators
European Society of Cutaneous Lupus Erythematosus e.V.
Principal Investigator: Annegret Kuhn, MD University of Muenster
  More Information

No publications provided

Responsible Party: Prof. Dr. Annegret Kuhn, Professor, Kuhn, Annegret Identifier: NCT00420173     History of Changes
Other Study ID Numbers: 2742-1
Study First Received: January 8, 2007
Last Updated: December 11, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by European Society of Cutaneous Lupus Erythematosus e.V.:
cutaneous lupus erythematosus
standardized evaluation
core set questionnaire
epidemiological data
laboratory features

Additional relevant MeSH terms:
Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Systemic
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Skin Diseases processed this record on November 24, 2015