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Status unknownNCT00420121Updated Feb 8, 2017

European Society of Cutaneous Lupus Erythematosus (EUSCLE)

An observational study in Lupus Erythematosus, Cutaneous and Lupus Erythematosus, Systemic, sponsored by European Society of Cutaneous Lupus Erythematosus e.V.. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-08.

Sponsored by European Society of Cutaneous Lupus Erythematosus e.V. · Observational

The sponsor has not verified this record recently (last verified Feb 2017), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
300
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Lupus Erythematosus, Cutaneous
  • Lupus Erythematosus, Systemic

Keywords

  • standardized evaluation
  • core set questionnaire
  • epidemiological data
  • laboratory analysis
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In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's planned enrollment of 300 is above the median of 140 across 283 observational studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

European Society of Cutaneous Lupus Erythematosus e.V. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with systemic or cutaneous lupus erythematosus

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
300 participants (estimated)

Interventions

  • Procedurelaboratory analysis

    blood withdrawal for laboratory analysis

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What researchers measure

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.

    Time frame: Up to 12 months

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Study locations

1 site
  • University of Muenster, Department of Dermatology
    Muenster, NRW 48149, Germany
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00420121
Lead sponsor
European Society of Cutaneous Lupus Erythematosus e.V.
Responsible party
Prof. Dr. Annegret Kuhn (Professor, European Society of Cutaneous Lupus Erythematosus e.V.) — Principal investigator
First posted
Jan 9, 2007
Start date
Jan 2007
Primary completion
Jul 2018 (estimated)
Completion
Dec 2019 (estimated)
Last update
Feb 8, 2017

Study contacts

Annegret Kuhn, MD
principal investigator · University of Muenster, Department of Dermatology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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