Interdisciplinary Study Group of Lupus Erythematosus (ISGLE)

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00420173
Study type	Observational
Source	European Society of Cutaneous Lupus Erythematosus e.V.
Contact
Status	Completed
Phase	N/A
Start date	September 2004
Completion date	June 2008

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01776190` - Low-dose UVA1 Radiation in Cutaneous Lupus Patients	N/A
Terminated	`NCT04809623` - Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)	Phase 1
Completed	`NCT01300208` - To Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus	Phase 2
Terminated	`NCT01470313` - A Multiple Dose Study Of PD-0360324 In Patients With Active Cutaneous Lupus Erythematosus	Phase 1
Completed	`NCT01146444` - Sunscreens in Patients With Cutaneous Lupus Erythematosus(CLE)	N/A
Completed	`NCT03134222` - Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)	Phase 2
Completed	`NCT01629784` - Effectiveness of a Knowledge-based Intervention for Patients With Cutaneous Lupus Erythematosus	N/A
Completed	`NCT00470912` - Sunscreen RV 2457C in Photoinduced CLE	Phase 3
Completed	`NCT01841619` - IVIg Efficacy Study to Treat Cutaneous Lupus Erythematosus	Phase 0
Completed	`NCT00523588` - Treatment of Cutaneous Lupus Erythematosus (CLE) With the 595 nm Flashlamp Pulsed Dye Laser	Phase 2
Recruiting	`NCT06411106` - Deep Phenotyping of Cutaneous Lupus Erythematosus	N/A
Not yet recruiting	`NCT06015737` - A 2-stage, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus	Phase 3
Terminated	`NCT01498406` - Vitamin D Status, Disease Specific and Quality of Life Outcomes in Patients With Cutaneous Lupus	Phase 2
Completed	`NCT04647708` - Study of M5049 in CLE and SLE Participants	Phase 1
Completed	`NCT03817424` - A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis	Phase 1
Active, not recruiting	`NCT03260166` - Nicotinamide Treatment for Lupus-associated Skin Lesions in Lupus Erythematosus	Phase 2
Completed	`NCT00317681` - Efficacy of Topical Tacrolimus in Different Subtypes With Cutaneous Lupus Erythematosus (CLE)	Phase 2
Completed	`NCT04781816` - Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.