NCT00420173

Brief Summary

Cutaneous lupus erythematosus (CLE) is a disease with a wide spectrum of clinical manifestations and a variable prognosis. The aim of this 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2007

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

December 12, 2013

Status Verified

December 1, 2013

Enrollment Period

10 months

First QC Date

January 8, 2007

Last Update Submit

December 11, 2013

Conditions

Cutaneous Lupus Erythematosus

Keywords

cutaneous lupus erythematosusstandardized evaluationcore set questionnaireepidemiological datalaboratory features

Study Arms (1)

Patients with CLE

Procedure: Laboratory analysis

Interventions

Laboratory analysisPROCEDURE

blood withdrawal

Patients with CLE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with cutaneous lupus erythematosus

You may qualify if:

  • cutaneous lupus erythematosus confirmed by histological analysis
  • photoprovocation-test performed in advance
  • written informed consent available prior to any procedures

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Muenster, Department of Dermatology

Münster, North Rhine-Westphalia, 48149, Germany

Location

MeSH Terms

Conditions

Lupus Erythematosus, Cutaneous

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Annegret Kuhn, MD

    Universität Münster

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
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

September 1, 2004

Primary Completion

July 1, 2005

Study Completion

June 1, 2008

Last Updated

December 12, 2013

Record last verified: 2013-12

Locations

DE(1)