Clinical trial NCT00420121: European Society of Cutaneous Lupus Erythematosus (EUSCLE)
Official title: European Society of Cutaneous Lupus Erythematosus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Systemic
Keywords: standardized evaluation
core set questionnaire
epidemiological data
laboratory analysis
Lead sponsor: European Society of Cutaneous Lupus Erythematosus e.V.
Sponsor class: OTHER
First posted: 2007-01-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with systemic or cutaneous lupus erythematosus

Brief summary: 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.

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 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

Primary outcomes:
measure: Activity and Damage of Skin Lesions in Patients with Cutaneous Lupus Erythematosus measured by the RCLASI Activity and Damage Score.
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: University of Muenster, Department of Dermatology
state: NRW
Study officials:
affiliation: University of Muenster, Department of Dermatology
name: Annegret Kuhn, MD
role: PRINCIPAL_INVESTIGATOR
References: