European Society of Cutaneous Lupus Erythematosus (EUSCLE)

NCT00420121 | Unknown

• 1 other identifier: 2742-2
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Systemic

Keywords

standardized evaluation; core set questionnaire; epidemiological data; laboratory analysis

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

laboratory analysis PROCEDURE

blood withdrawal for laboratory analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with systemic or cutaneous lupus erythematosus

You may qualify if:

• systemic or cutaneous lupus erythematosus confirmed by histological analysis
• written informed consent available prior to any study-procedures

You may not qualify if:

• patients with conditions that are contrary to the above mentioned criteria

Sponsors & Collaborators

• European Society of Cutaneous Lupus Erythematosus e.V.: lead

Study Sites (1)

University of Muenster, Department of Dermatology

Münster, North Rhine-Westphalia, 48149, Germany

Location

MeSH Terms

Conditions

Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Annegret Kuhn, MD

  University of Muenster, Department of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 8, 2007
• First Posted: January 9, 2007
• Study Start: January 1, 2007
• Primary Completion: July 1, 2018
• Study Completion: December 1, 2019
• Last Updated: February 8, 2017

Record last verified: 2017-02

Locations

DE (1)