European Society of Cutaneous Lupus Erythematosus (EUSCLE)

Lupus Erythematosus, Systemic Clinical Trial

Official title:

European Society of Cutaneous Lupus Erythematosus

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00420121
• Other study ID #: 2742-2
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 8, 2007
• Last updated: February 7, 2017
• Start date: January 2007
• Est. completion date: December 2019

Study information

• Verified date: February 2017
• Source: European Society of Cutaneous Lupus Erythematosus e.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: December 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Cutaneous
• Lupus Erythematosus, Systemic

Intervention

Procedure:
• laboratory analysis
blood withdrawal for laboratory analysis

Locations

Country	Name	City	State
Germany	University of Muenster, Department of Dermatology	Muenster	NRW

Sponsors (1)

Lead Sponsor	Collaborator
European Society of Cutaneous Lupus Erythematosus e.V.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activity and Damage of Skin Lesions in Patients with Cutaneous Lupus Erythematosus measured by the RCLASI Activity and Damage Score.	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.	Up to 12 months