cutaneous lupus erythematosus lupus affecting the skin
Conditions
Interventions
None listed
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Eligible healthy volunteers must meet all the following inclusion criteria at screening: 1. Signed informed consent prior to any study-mandated procedure. 2. Male or female subjects,18-65 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. 3. Body mass index (BMI) > 18.0 and < 32.0 kg/m2. 4. Fitzpatrick skin type I-III (Caucasian). 5. No clinically significant skin disease as judged by the investigator. 6. No history of hypertrophic scarring or keloid. 7. Subject is willing to refrain from application of any topical product (e.g., ointments, cream or washing lotions) on the skin 24 hours prior to every study visit day. 8. Subject is willing to refrain from any direct sun contact to the area being challenged (back) for the duration of the study. 9. Subject has the ability to communicate well with the investigator in the Dutch language and is willing to comply with the study requirements. Eligible CLE patients must meet all the following inclusion criteria at screening: 1. Signed informed consent prior to any study-mandated procedure. 2. Male or female CLE patients, 18-65 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. 3. Body mass index (BMI) > 18.0 and < 35.0 kg/m2. 4. Fitzpatrick skin type I-III (Caucasian). 5. Patient has the ability to communicate well with the investigator in the Dutch language and is willing to comply with the study requirements. 6. Subject is willing to refrain from application of any topical product (e.g., ointments, cream or washing lotions) on the skin 24 hours prior to every study visit day. 7. Subject is willing to refrain from any direct sun contact to the area being challenged (back) for the duration of the study 8. Participants must have a diagnosis of CLE that fulfils the following: * Confirmed diagnosis by clinicopathological correlation. * Receiving one of the following treatments for CLE (stable for a minimum of 8 weeks): * None * Hydroxychloroquine * Methotrexate * Topical corticosteroids (for the target lesion there will be a wash out of 2 weeks before the first challenge period)
Exclusion criteria
Exclusion criteria: Eligible healthy volunteers must meet none of the following exclusion criteria at screening: 1. (History of) immunological abnormality (e.g., immune suppression by medication, auto-immune disease, auto-inflammatory disease) that may interfere with study objectives, in the opinion of the investigator. 2. History of skin cancer (basal cell carcinoma, squamous cell carcinoma, melanoma); 3. Diagnosis of systemic lupus erythematosus (SLE) according to the EULAR-ACR criteria (2019) or substantial indication for systemic involvement. 4. Have any current and/or recurrent clinically significant skin condition, including tattoos, in the skin area of interest (back). 5. Antibiotic use, operation, or intervention by surgeon/dentist within one month before Day 1. 6. Positive hepatitis B surface antigen (HbsAg), hepatitis C antibody (HCV ab), or human immunodeficiency virus antibody (HIB ab) at screening. 7. Participation in an investigational drug study within 3 months prior to screening or more than 4 times a year. 8. Loss or donation of blood over 500mL within three months prior to screening. 9. The use of any medication within 28 days prior to Day 1 (apart from the allowed CLE-medication in patients), if the investigator judges it may interfere with the study objectives. 10. History of alcohol abuse or consumption exceeding 5 standard drinks per day on average within 3 months of screening. Alcohol consumption will be prohibited from at least 24 hours preceding each study visit. 11. Positive urine test for drugs or history of drug abuse at screening. Urine drug test may be repeated at the discretion of the investigator. 12. Pregnant, a positive pregnancy test, intending to become pregnant during the study conduct, or breastfeeding. 13. (A history of) any clinically significant medical condition, factor or abnormality that might interfere with study conduct or interpretation, as judged by the investigator. 14. A minimal erythema dose (MED) higher than 355 mJ/cm2 at screening. 15. Any active or chronic and/or uncontrolled condition that, in the opinion of the investigator, may influence study conduct or interpretation. Eligible CLE patients must meet none of the abovementioned and following exclusion criteria at screening: 1. Presence of a relevant skin infection or disease in the target areas other than the observational disease (CLE), inclusively, but not limited to atopic dermatitis, psoriasis vulgaris and dermatomycosis. 2. Having received treatments for CLE or any other disease within the following intervals prior to Day 1: a. < 2 weeks for topical treatment, e.g., corticosteroids at target area(s). b. < 6 weeks for systemic therapy with immunosuppressive agents (other than hydroxychloroquine). c. < 12 weeks for biologics. d. < 8 weeks procedure or surgery in or close to the target areas. e. < 3 months for chemotherapeutical treatment. 3. Low complement (C3 and/or C4) levels at screening (< ULN). 4. Positive ANA and anti-dsDNA and/or anti-SM antibodies at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - To characterize the dermal immune response of healthy volunteers following a UV-B skin challenge - To characterize the dermal immune response of CLE patients following a UV-B skin challenge on non-lesional skin - To evaluate the test-retest variability of the UV-B challenge in healthy volunteers and CLE patients | — |
Secondary
| Measure | Time frame |
|---|---|
| - To evaluate disease-related characteristics and biomarkers in patients with CLE compared to healthy volunteers - To evaluate time-related changes in disease-related characteristics in patients with CLE | — |
Countries
Netherlands
Outcome results
None listed