Deep Phenotyping of Cutaneous Lupus Erythematosus (NCT06411106) | Clinical Trial Compass
UnknownNot Applicable
Deep Phenotyping of Cutaneous Lupus Erythematosus
Netherlands40 participantsStarted 2024-06
Plain-language summary
Cutaneous lupus erythematosus (CLE) is an autoimmune disease of which the pathogenesis and pathophysiology are not fully understood. Given the complex and heterogeneous character of the disease, identification, and development of specific biomarkers for diagnosis, disease subtyping, disease severity, and treatment response in CLE is challenging. Therefore, the main objective of the current study is to further characterize CLE by using a deep phenotyping approach. Moreover, the role of TLR7 activation in the pathophysiology of the various clinical subtypes of CLE will be specifically studied. With this approach the investigators aim to characterize objectively measured disease characteristics and detect novel biomarkers for CLE(-subtypes).
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed informed consent prior to any study-mandated procedure.
. Male or female subjects, 18 to 65 years of age at the time of signing informed consent; in general, stable good health as per judgement of the investigator based upon the results of a medical history, physical examination, vital signs, ECG, and laboratory assessments performed at screening. Repeated laboratory testing may be performed at the discretion of the clinical investigator.
. Body mass index (BMI) \> 18.0 and \< 32.0 kg/m2
. Fitzpatrick skin type I-III (Caucasian).
. Subjects and their partners of childbearing potential must use effective contraception for the duration of the study.
. No clinically significant skin disease as judged by the investigator.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Subject is willing to refrain from application of any topical product (e.g., ointments, cream or washing lotions) on the target lesion(s)skin 24 hours prior to every study visit day.
Exclusion criteria
. (History of) immunological abnormality (e.g., immune suppression) that may interfere with study objectives, in the opinion of the investigator.
. Have any current and/or recurrent clinically significant skin condition, including tattoos.
. Antibiotic use, operation, or clinically significant intervention by surgeon/dentist within one month before Day 1.
. Positive hepatitis B surface antigen (HbsAg), hepatitis C antibody (HCV ab), or human immunodeficiency virus antibody (HIV ab) at screening.
. Participation in an investigational drug study within 3 months prior to screening or more than 4 times a year.
. Loss or donation of blood over 500mL within three months prior to screening.
. Subject is willing to refrain from the use of any medication within 28 days prior to Day 1, if the investigator judges it may interfere with the study objectives.
. History of alcohol abuse or consumption exceeding 5 standard drinks per day on average within 3 months of screening.
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Faecal microbiome (optional for patients)
Timeframe: Day 15
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Circulating cytokines
Timeframe: Day 15
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Interferon (IFN) signature
Timeframe: Day 15
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User experience and subjective burden questionnaire