European Society of Cutaneous Lupus Erythematosus (EUSCLE)
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ClinicalTrials.gov Identifier: NCT00420121
Recruitment Status : Unknown
Verified February 2017 by Prof. Dr. Annegret Kuhn, European Society of Cutaneous Lupus Erythematosus e.V.. Recruitment status was: Enrolling by invitation
First Posted : January 9, 2007
Last Update Posted : February 8, 2017
European Society of Cutaneous Lupus Erythematosus e.V.
Information provided by (Responsible Party):
Prof. Dr. Annegret Kuhn, European Society of Cutaneous Lupus Erythematosus e.V.
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.
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.
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with systemic or cutaneous lupus erythematosus
systemic or cutaneous lupus erythematosus confirmed by histological analysis
written informed consent available prior to any study-procedures
patients with conditions that are contrary to the above mentioned criteria