Atopic dermatitis, chronic spontaneous urticaria, hidradenitis suppurativa, cutaneous lupus erythematosus, cutaneous T-cell lymphoma (CTCL) subtype mycosis fungoides, and psoriasis. Atopic eczema, hives, hidradenitis, skin lupus, skin lympoma subtype MF, psoriasis
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: All patients must meet all of the following inclusion criteria for study entry: 1. Able to understand and provide a written informed consent prior to any study procedures 2. Male or non-pregnant female, >=18 years of age 3. Patient is willing to refrain from extensively washing (including bathing, swimming) the target lesional skin 12 hours before every study visit day. 4. Patient is willing and able to comply with the study protocol 5. Female participants are willing to not get pregnant 6. The patient is willing to start the prescribed treatment. Additionally, there are disease specific inclusion criteria. The most important inclusion criteria: For patients with AD: 6. Diagnosis and history of chronic, moderate-to-severe AD (by the Eichenfield revised criteria of Hanifin and Rajka for at least 3 years before baseline visit. 7. Documented recent history (last 6 months) of eligibility for (local or systemic) treatment with immunosuppressants, biologics or JAK-inhibitors. 10. EASI>=7 (moderate-to-severe disease) For patients with CLE 6. Confirmed CLE diagnosis by clinicopathological correlation. 7. An overall CLE Disease Area and Severity Index Activity (CLASI-A) Score >=3 without counting any diffuse alopecia or oral ulcers. For patients with CSU: 6. Diagnosis of CSU (moderate to severe according to international guidelines (Zuberbier et al, 2022)) for >=3 months and symptomatic disease despite treatment with second generation H1 antihistamines (up to fourfold the approved dose). For patients with HS: 6. Patient with a history of signs and symptoms consistent with moderate-to-severe HS, based on IHS4 score (Zouboulis et al., 2017), for at least 1 year prior to baseline For patients with MF: 6. A confirmed diagnosis of CTCL MF type and stage classification via histology or clinicopathological correlation 7. For the stage IA-IIA CTCL patients: at least one patch and/or one plaque lesion is present For patients with PSO: 6. Diagnosed with chronic plaque psoriasis at least 6 months prior to study participation 7. PASI>=5 with at least one suitable target lesion at the discretion of the investigator
Exclusion criteria
Exclusion criteria: All patients must meet none of the following exclusion criteria: 1. Have any other relevant skin infection/disease in the treatment area other than the investigated skin disease. 2. Subjects who have received treatment with any non-marketed drug substance (that is, an agent which has not yet been made available for clinical use following registration) within 4 weeks prior to the baseline visit. 3. Any other condition, disease, or known factor that could interfere with the study conduct or the study objectives as per judgement of the investigator. 4. Having received treatments for the investigated skin disease within the following intervals prior to the start of the study is not a strict exclusion criterion since this is a real-world study. However, preferred intervals for washout are as follows: a. 1 week for topical treatment, e.g. corticosteroids, retinoids, vitamin D analogs, calcineurin inhibitors b. 4 weeks for phototherapy, e.g. UVB, PUVA, PDT c. 4 weeks for non-biologic systemic treatment, e.g. retinoids, methotrexate, cyclosporine, JAK inhibitors d. 8 weeks for radiotherapy or surgery in the treatment area e. 8 weeks for biologics f. 3 months for any systemic chemotherapeutical treatment Additionally, there are disease specific exclusion criteria. The most important exclusion criteria: Disease specific exclusion criteria for patients with CLE: 5. Diagnosed with SLE Disease specific exclusion criteria for patients with CSU: 5. Urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary, acquired angioedema or drug-induced (e.g., due to C1 esterase inhibitor deficiency, ACE-inhibitor induced). Disease specific exclusion criteria for patients with MF: 5. Ongoing uncontrolled active skin infection, other than secondary impetiginized CTCL lesions as judged by the investigator Disease specific exclusion criteria for patients with PSO: 5. Having primarily erythrodermic, pustular or guttate psoriasis; 6. Having drug-induced psoriasis;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study will monitor the change over time in following biomarkers: - Percentage of patient (non-)responders - Delta clinical parameters (per disease) at 3,6, 12 months o Total body: PGA, vIGA-AD, EASI, PASI, CLASI-A, IHS4-55%, UAS-7, mSWAT - Target lesion: TSS, CAILS - Time to switch to another therapy - Tape strips and swabs: o Microbiome (lesional, non-lesional) o Lipidomics (lesional, non-lesional) o Proteomics (lesional, non-lesional) - Imaging o Target lesion photography - Blood based: o Circulating biomarkers | — |
Secondary
| Measure | Time frame |
|---|---|
| - Patient reported outcomes (DLQI, TSQM, ePRO: NRS pruritus. NRS burning/pain, SGA) + disease specific, weekly lesion imaging o CSU: UCT, UAS7 o HS: HiSQOL - Quality of sleep (activity by smartwatch): o Sleep duration o Number of awakenings o Light sleep duration o Deep sleep duration o Sleep efficiency - Number of steps and heart rate (activity by smartwatch) - Percentage of therapy failures and dropouts - Type, frequency, and quantity of topical therapies used - Percentage of patients (responders) - Decrease in disease activity o Physician Global Assessment =****1), 6-9-12 months (EASI* | — |
Countries
Netherlands
Contacts
Public ContactR. Rissmann
Leids Universitair Medisch Centrum
Outcome results
None listed