An Exploratory, Single-center, Two-part Study to Characterize Cutaneous Lupus Erythematosus and Investigate the Effect of an Immune Challenge by Comparing CLE Patients With Healthy Volunteers
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).
• 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.
• No history of hypertrophic scarring or keloid.
• 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.
• Subject has the ability to communicate well with the investigator in the Dutch language and is willing to comply with the study requirements.
• Signed informed consent prior to any study-mandated procedure.
• Male or female CLE patients, 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 investigators.
• Body mass index (BMI) \> 18.0 and \< 35.0 kg/m2.
• Only applicable for CDLE patients who will also participate in part B: Fitzpatrick skin type I-III (Caucasian).
• Subjects and their partners of childbearing potential must use effective contraception for the duration of the study.
• Patient has the ability to communicate well with the investigator in the Dutch language and is willing to comply with the study requirements.
• Subject is willing to refrain from application of any topical product (e.g., ointments, cream or washing lotions) on the target lesion(s) 24 hours prior to every study visit day.
• Participants must have a diagnosis of SCLE, CDLE or LET that fulfils the following:
‣ Confirmed CLE diagnosis by clinicopathological correlation.
⁃ At least one CLE skin lesion of at least 3x3 cm suitable as assessed by the investigator for measurements performed in the study.
⁃ Location of the lesion(s) selected for biopsy outside the face (possible are e.g., neck, chest, back, limbs, scalp, ear etc.).
⁃ Receiving one of the following systemic treatments for CLE (stable for a minimum of 8 weeks):
• None
∙ Hydroxychloroquine
⁃ An overall CLE Disease Area and Severity Index Activity (CLASI-A) Score ≥3 without counting any diffuse alopecia or oral ulcers