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European Society of Cutaneous Lupus Erythematosus (EUSCLE)

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00420121
First Posted: January 9, 2007
Last Update Posted: February 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof. Dr. Annegret Kuhn, European Society of Cutaneous Lupus Erythematosus e.V.
  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 Prof. Dr. Annegret Kuhn, European Society of Cutaneous Lupus Erythematosus e.V.:

Primary Outcome Measures:
  • Activity and Damage of Skin Lesions in Patients with Cutaneous Lupus Erythematosus measured by the RCLASI Activity and Damage Score. [ Time Frame: Up to 12 months ]

    The Total RCLASI Activity Score measures (i) the activity of skin lesions by evaluating the parameters "erythema", "scaling ⁄hyperkeratosis", "oedema ⁄Infiltration", and "subcutaneous nodule ⁄plaque" and/or (ii) the activity of mucous membrane lesions and/or (iii) the activity of alopecia.

    The Total RCLASI Damage Score measures (i) the damage of skin lesions by evaluating the parameters "dyspigmentation" and "scarring/atrophy" and/or (ii) the damage of scarring alopecia.



Estimated Enrollment: 300
Study Start Date: January 2007
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00420121


Locations
Germany
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, Department of Dermatology
  More Information

Responsible Party: Prof. Dr. Annegret Kuhn, Professor, European Society of Cutaneous Lupus Erythematosus e.V.
ClinicalTrials.gov Identifier: NCT00420121     History of Changes
Other Study ID Numbers: 2742-2
First Submitted: January 8, 2007
First Posted: January 9, 2007
Last Update Posted: February 8, 2017
Last Verified: February 2017

Keywords provided by Prof. Dr. Annegret Kuhn, European Society of Cutaneous Lupus Erythematosus e.V.:
standardized evaluation
core set questionnaire
epidemiological data
laboratory analysis

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases