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Interdisciplinary Study Group of Lupus Erythematosus (ISGLE)

NCT ID: NCT00420173

Last Updated: 2013-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-09-30

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cutaneous Lupus Erythematosus

Keywords

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cutaneous lupus erythematosus standardized evaluation core set questionnaire epidemiological data laboratory features

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with CLE

Laboratory analysis

Intervention Type PROCEDURE

blood withdrawal

Interventions

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Laboratory analysis

blood withdrawal

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Society of Cutaneous Lupus Erythematosus e.V.

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Annegret Kuhn

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Annegret Kuhn, MD

Role: PRINCIPAL_INVESTIGATOR

Universität Münster

Locations

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University of Muenster, Department of Dermatology

Münster, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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2742-1

Identifier Type: -

Identifier Source: org_study_id