Interdisciplinary Study Group of Lupus Erythematosus (ISGLE)

Sponsor
European Society of Cutaneous Lupus Erythematosus e.V. (Other)
Overall Status
Completed
CT.gov ID
NCT00420173
Collaborator
(none)
45
1
45
1

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational
Actual Enrollment :
45 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Interdisciplinary Study Group of Lupus Erythematosus
Study Start Date :
Sep 1, 2004
Actual Primary Completion Date :
Jul 1, 2005
Actual Study Completion Date :
Jun 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Patients with CLE

Procedure: Laboratory analysis
blood withdrawal

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University of Muenster, Department of Dermatology Muenster NRW Germany 48149

    Sponsors and Collaborators

    • European Society of Cutaneous Lupus Erythematosus e.V.

    Investigators

    • Principal Investigator: Annegret Kuhn, MD, University of Muenster

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof. Dr. Annegret Kuhn, Professor, Kuhn, Annegret
    ClinicalTrials.gov Identifier:
    NCT00420173
    Other Study ID Numbers:
    • 2742-1
    First Posted:
    Jan 9, 2007
    Last Update Posted:
    Dec 12, 2013
    Last Verified:
    Dec 1, 2013

    Study Results

    No Results Posted as of Dec 12, 2013