Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00420121
Status:
UNKNOWN
Last Update Posted:
2017-02-08
First Post:
2007-01-08
Brief Title:
European Society of Cutaneous Lupus Erythematosus EUSCLE
Sponsor:
European Society of Cutaneous Lupus Erythematosus eV
Organization:
European Society of Cutaneous Lupus Erythematosus eV
Study Overview
Official Title:
European Society of Cutaneous Lupus Erythematosus
Status:
UNKNOWN
Status Verified Date:
2017-02
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 625 exhibited characteristic lesions after standardized phototesting Laboratory analysis revealed positive antinuclear antibodies in 50 of the patients positive anti-RoSSA in 12 and positive anti-LaSSB 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None