European Society of Cutaneous Lupus Erythematosus (EUSCLE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Kuhn, Annegret.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kuhn, Annegret
ClinicalTrials.gov Identifier:
NCT00420121
First received: January 8, 2007
Last updated: June 14, 2011
Last verified: June 2011
  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

Resource links provided by NLM:


Further study details as provided by Kuhn, Annegret:

Estimated Enrollment: 300
Study Start Date: January 2007
Estimated Study Completion Date: December 2012
Intervention Details:
    Procedure: laboratory analysis
    blood withdrawal for 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.

  Eligibility

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 systemic or cutaneous lupus erythematosus

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00420121

Contacts
Contact: Annegret Kuhn, MD +49-251-8352210
Contact: Nikolaos Patsinakidis, MD +49-251-8352163

Locations
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            
Sponsors and Collaborators
Kuhn, Annegret
Investigators
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