Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07021495

SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)

The goal of this observational study is to comprehensively profile six immune-mediated inflammatory diseases, including atopic dermatitis (AD), plaque psoriasis (PSO), hidradenitis suppurativa (HS), cutaneous T-cell lymphoma subtype mycosis fungoides (MF), chronic spontaneous urticaria (CSU), and cutaneous lupus erythematosus (CLE) in daily practice. Data will be compared with data from healthy volunteers. This study is part of the larger NGID (Next Generation ImmunoDermatology) initiative, of which the main objective is to develop infrastructure that enables personalised patient care. The main questions the SKINERGY study aims to answer are:

* Which biomarkers can discriminate between responders and non-responders to treatment in patients with AD, CLE, CSU, HS, MF, and PSO? * How do disease-related biomarkers in patients with AD, CLE, CSU, HS, MF, and PSO differ from those in healthy volunteers? * Which (multi-omics) biomarkers are associated with disease subtypes and predict response or non-response to (targeted) therapies in daily clinical practice? * How do biomarker profiles compare across different cohorts of patients with immune-mediated inflammatory skin diseases (AD, CLE, CSU, HS, MF, PSO) * How do biomarker levels change over time in response to treatment in these patient populations? * Which skin tissue biomarkers are associated with disease progression or treatment response? * How do the genomic profiles of patients differ across diseases or correlate with treatment outcomes? * Can additional imaging biomarkers enhance the characterization of disease profiles or treatment monitoring over time?

Researchers will compare both differences beween patients within a disease group in different treatment arms, as well as patients within the same treatment arm. Additionally, biomarker profiles of patients with different diseases will be evaluated. These comparisons will be made to see if shared or distinct biomarker patterns exist across diseases and treatments, which could inform patient stratification, optimize therapeutic decision-making, and identify potential targets for future interventions.

Participants will start medication according to national guidelines for the treatment of their inflammatory skin disease (AD: Cyclosporin A, anti-IL4/13, or anti-JAK; PSO: anti-TNF, anti-IL23, ani-IL17, anti-TYK2; HS: anti-TNF, anti-IL17; MF: CHLORM, TSC, PUVA-UV-B; CSU: anti-IgE, Cyclosporin A, anti-BTK*; CLE: TSC, HCQ, MTX)

*once approved and reimbursed in the Netherlands

Participants will:

* Take the prescribed medication for their skin disease (in line with standard care in the Netherlands). * Visit the clinic for a study visit combined with their standard care appointment 3 times (baseline, month 3, and month 6. An additional 4th visit at month 12 is optional). * Fill in an online set of questionnaires from home, 3 times during the study period (an additional 4th time is optional). * Patients with CSU fill in the UAS7 (and if applicable the AAS7) daily for the study period.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Chronic Spontaneous Urticaria (CSU) Abscess Angioedema Atopic Dermatitis (AD) Bacterial Infections Bacterial Infections and Mycoses CTCL/ Mycosis Fungoides Cardiovascular Diseases Chronic Disease Chronic Urticaria Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Disease Attributes Eczema Erythema Exanthema Genetic Diseases, Inborn Hemic and Lymphatic Diseases Hidradenitis Hidradenitis Suppurativa Hidradenitis Suppurativa (HS) Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunoproliferative Disorders Infections Inflammation Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Mycosis Fungoides Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Photosensitivity Disorders Plaque, Amyloid Pruritus Psoriasis Psoriasis (PsO) Signs and Symptoms Skin Diseases Skin Diseases, Bacterial Skin Diseases, Eczematous Skin Diseases, Genetic Skin Diseases, Infectious Skin Diseases, Papulosquamous Skin Diseases, Vascular Skin Manifestations Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases Urticaria Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboud University Medical Center, Nijmegen, Gelderland, Netherlands

Loading trial locations.

About this study

Atopic dermatitis (AD), cutaneous lupus erythematosus (CLE), chronic spontaneous urticaria (CSU), hidradenitis suppurativa (HS), cutaneous T-cell lymphoma (CTCL, subtype mycosis fungoides, MF), and plaque psoriasis (PSO) are diverse immune-mediated inflammatory skin diseases with complex and often poorly understood pathophysiologies. Genetic, immunological, and environmental factors contribute variably across these conditions, leading to heterogeneous clinical presentations. Despite advances, the identification and validation of specific biomarkers remain limited, hampering precise diagnosis, disease subtyping, and treatment response prediction. For example, AD involves epidermal barrier defects and immune dysregulation; CLE features autoimmune mechanisms and diverse clinical subtypes; CSU results from mast cell activation; HS is driven by follicular occlusion and chronic inflammation; CTCL involves malignant T-cell proliferation in the skin; and PSO is characterized by immune-driven keratinocyte hyperproliferation. The Next Generation ImmunoDermatology project aims to address these challenges by deeply profiling these diseases to discover biomarkers that define disease endotypes and predict therapy response, ultimately enabling personalized treatment strategies.

The investigations will profile various aspects of the disease, including patient-reported outcomes, the clinician-reported outcomes, biophysical, imaging, cellular, microbiological, molecular, blood-based and tissue biomarkers.

This multicenter, open-label, longitudinal biomarker study follows 720 patients with six inflammatory skin diseases-AD, PSO, HS, CSU, CLE, and MF-for one year after starting standard-of-care treatment. Multimodal data are collected at baseline, 3, 6, and 12 months. An additional 120 healthy controls are included for baseline comparison and followed for 6 weeks. Each disease includes multiple treatment arms (N=40 per arm):

  • AD: cyclosporine A; anti-IL-4/13 (dupilumab, tralokinumab, lebrikizumab); JAK1 inhibitors (upadacitinib, abrocitinib)
  • PSO: anti-IL-23 (guselkumab, risankizumab, tildrakizumab); anti-IL-17 (secukinumab, ixekizumab, brodalumab, bimekizumab); anti-TNFα (adalimumab, certolizumab); TYK2 inhibitor (deucravacitinib)
  • HS: anti-TNFα (adalimumab); anti-IL-17 (secukinumab, bimekizumab*)
  • MF: topical chlormethine; topical corticosteroids; phototherapy (PUVA/UV-B)
  • CSU: anti-IgE (omalizumab*); cyclosporine A; BTK inhibitors* (remibrutinib, rilzabrutinib)
  • CLE: topical corticosteroids; hydroxychloroquine; methotrexate

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients:

  • Able to understand and provide a written informed consent prior to any study procedures
  • Male or non-pregnant female, ≥18 years of age
  • Patient is willing to refrain from extensively washing (including bathing, swimming) the target lesional skin 12 hours before every study visit day.
  • Patient is willing and able to comply with the study protocol
  • Female participants are willing to not get pregnant between M0 until M12, from study entry to the last study visit
  • The patient is willing to start the prescribed treatment.

Disease-specific inclusion criteria

For patients with AD:

To be eligible to participate in this study, a subject must meet all of the following criteria:

  • 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.
  • Documented recent history (last 6 months) of eligibility for (local or systemic) treatment with immunosuppressants, biologics or JAK-inhibitors.
  • When applicable, documented recent history (last 6 months) of inadequate response to treatment with topical therapy, immunosuppressants, biologics or JAK-inhibitors.
  • Current treatment can include moisturizers, topical treatment and/or systemic treatments with preferable wash-out (see exclusion criterion #9). On-study treatment is at physician and patient discretion but must include eligibility to starting new systemic treatment.
  • EASI≥7 (moderate-to-severe disease) 11. At least one suitable target lesion at the discretion of the investigator 12. Intention to start treatment with cyclosporine A, dupilumab, tralokinumab, lebrikizumab or a JAK1-inhibitor (abrocitinib or upadacitinib)

For patients with CLE:

Participants must have a diagnosis of CLE, including SCLE, CDLE or LET that fulfil the following:

  • 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.
  • Intention to start treatment with TCS, hydroxychloroquine or methotrexate (combination or mono-treatment).

If participating in the exploratory study with the skin biopsy: location of the lesion(s) selected for biopsy preferably outside the facial area (possible are e.g., neck, chest, back, limbs, scalp, ear etc.).

For patients with CSU:

  • 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).

7.Patients currently on an antihistamine (up to fourfold the approved dose) must be on a stable dose for at least 2 weeks prior to day 1 and must maintain the same stable dose throughout the treatment period.

  • Intention to start (add-on to antihistamine) treatment of omalizumab, cyclosporine A or BTK inhibitor*. (*when approved and reimbursed in NL)

For patients with HS:

  • 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 7. Current treatment can include topical treatment. On-study treatment is at physician and patient discretion but must include eligibility to starting systemic treatment 8. Intention to start treatment with anti-TNF or anti-IL17 (secukinumab, bimekizumab*) *when approved and reimbursed in NL.

For patients with MF:

  • 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 8. Intention to start treatment with topical chlormethine, topical corticosteroids or phototherapy (PUVA / UV-B).

For patients with PSO:

  • 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 8. Current treatment can include moisturizers, topical treatment and/or systemic treatments with preferable wash-out. On-study treatment is at physician and patient discretion but must include eligibility to starting new systemic treatment 9. Intention to start treatment with biologics: anti-TNF, anti-IL23, anti-IL17 or anti-TYK2

Healthy volunteers:

All healthy volunteers must meet all of the following inclusion criteria:

  • Signed informed consent before any study-mandated procedure.
  • Male or non-pregnant female volunteers, ≥18 years of age
  • Subject is in stable good health as per judgement of the investigator based upon the results of medical history and assessments performed at baseline.
  • No clinically significant skin disease as judged by the investigator.
  • No history of hypertrophic scarring or keloid.
  • Subject is willing to refrain from extensively washing (including bathing, swimming) the skin 12 hours before every study visit.
  • Subject is willing and able to wash out and withhold any topical treatment (prescription and over-the-counter products) in the investigational area for 2 weeks prior to Day 1.
  • 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.
  • Subject is willing and able to wash out any antibiotic therapy for 14 days prior to Day 1.
  • Subject is willing and able to comply with the study protocol.
  • Female participants are willing to not get pregnant from study entry to the last study visit

Exclusion criteria

Patients:

  • Have any other relevant skin infection/disease in the treatment area other than the investigated skin disease.
  • 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.
  • 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:
  • 1 week for topical treatment, e.g. corticosteroids, retinoids, vitamin D analogs, calcineurin inhibitors
  • 4 weeks for phototherapy, e.g. UVB, PUVA, PDT
  • 4 weeks for non-biologic systemic treatment, e.g. retinoids, methotrexate, cyclosporine, JAK inhibitors
  • 8 weeks for radiotherapy or surgery in the treatment area
  • 8 weeks for biologics
  • 3 months for any systemic chemotherapeutical treatment

Disease specific exclusion criteria for patients with CLE:

  • Diagnosed with SLE

Disease specific exclusion criteria for patients with CSU:

  • Treatment with omalizumab within 8 weeks prior to Day 1 6. 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:

  • Ongoing uncontrolled active skin infection, other than secondary impetiginized CTCL lesions as judged by the investigator

Disease specific exclusion criteria for patients with PSO:

  • Having primarily erythrodermic, pustular or guttate psoriasis; 6. Having drug-induced psoriasis;

Healthy volunteers:

All healthy volunteers must meet none of the following exclusion criteria:

  • History of immunological abnormality (e.g. immune suppression, severe allergy, or anaphylaxis) that may interfere with study objectives as per judgement of the investigator.
  • History or symptoms of any uncontrolled, significant disease including (but not limited to), a neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder that may interfere with the study objectives as per judgement of the investigator.
  • The use of systemic antibiotic therapy for >2 months in the past 12 months.
  • The use of any immunosuppressive or immunomodulatory therapy within the past 30 days prior to Day 1.
  • Loss or donation of blood over 500mL within three months prior to baseline. Participation in an investigational drug study within 3 months prior to baseline visit or more than 4 times a year.
  • History of alcohol consumption exceeding 5 standard drinks per day on average within 3 months prior to baseline. Alcohol consumption will be prohibited for at least 24 hours preceding each study visit.
  • Positive urine test for drugs or history of abuse at baseline. 9. Exposure to high doses of UV radiation is not permitted within 3 weeks of the first study visit until the end of the study 10. Extreme physical activities are not permitted within 48 hours before each study visit 11. Any other condition, disease, or known factor that could interfere with the study conduct or the study objectives as per judgement of the investigator.

Treatment and study plan

Primary outcomes

  1. Lipidomics of the stratum corneum and OLINK

    Time frame: Baseline - month 12

    Tape stripping will be performed on (non-)lesional skin and healthy skin for extraction of lipids for analysis and analysis will be performed using OLINK.

  2. Cutaneous microbiome

    Time frame: Baseline - month 12

    The microbiome is collected by swabbing. The abundance of bacteria is thereafter determined using next-generation sequencing.

  3. Serum biomarkers

    Time frame: Baseline - month 12

    Blood serum will be collected and processed for subsequent biomarker extraction and analysis. The specific biomarkers to be assessed will be determined at a later stage, based on the results of preliminary pilot studies.

  4. Plasma biomarkers

    Time frame: Baseline - month 12

    Blood plasma will be collected and processed for the extraction and analysis of biomarkers. The specific biomarkers to be assessed will be determined at a later stage, based on the results of preliminary pilot studies.

  5. Eczema Area and Severity Index (EASI)

    Time frame: Baseline - month 12

    The Eczema Area and Severity Index (EASI) is a validated clinician-reported outcome measure used to assess the severity and extent of atopic dermatitis. The total EASI score ranges from 0 to 72, with higher scores indicating more severe disease. A score of 0 reflects no disease activity, whereas a score of 72 represents the most severe possible presentation.

    The EASI score will be assessed exclusively in patients diagnosed with atopic dermatitis.

  6. objective Severity Scoring of Atopic Dermatitis (oSCORAD)

    Time frame: Baseline - month 12

    The objective SCORAD (oSCORAD) is a validated clinician-reported outcome measure used to evaluate the severity of atopic dermatitis, focusing on objective clinical signs. The total oSCORAD score ranges from 0 to 83, with higher scores indicating more severe disease. A score of 0 reflects the absence of clinical symptoms, while a score of 83 represents the most severe disease presentation.

    The oSCORAD score will be assessed exclusively in patients diagnosed with atopic dermatitis.

  7. Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD)

    Time frame: Baseline - month 12

    The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) is a clinician-reported outcome measure used to assess the overall severity of atopic dermatitis based on clinical signs. The vIGA-AD score ranges from 0 to 4, with higher scores indicating more severe disease. A score of 0 corresponds to "clear" skin, while a score of 4 represents "severe" disease.

    The vIGA-AD score will be assessed exclusively in patients diagnosed with atopic dermatitis.

  8. Cutaneous LE Disease Area and Severity Index Activity (CLASI-A)

    Time frame: Baseline - month 12

    The Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity Score (CLASI-A) is a validated clinician-reported outcome measure used to assess the degree of inflammatory disease activity in patients with cutaneous lupus erythematosus. The CLASI-A score ranges from 0 to 70, with higher scores indicating more active and severe skin involvement. A score of 0 reflects no disease activity, while a score of 70 indicates the most severe activity.

    The CLASI-A score will be assessed exclusively in patients diagnosed with cutaneous lupus erythematosus.

  9. Total Sum Score

    Time frame: Baseline - month 12

    The Total Sum Score is a clinician-reported composite outcome measure used to quantify overall disease activity in patients with cutaneous lupus erythematosus and psoriasis. It is calculated by summing the individual scores of predefined clinical signs across affected body regions. The score range depends on the number and weighting of assessed parameters, with higher scores indicating more severe disease activity. A score of 0 reflects no observable disease, whereas the maximum score represents the most severe manifestation based on the scoring algorithm.

    The Total Sum Score will be assessed only in patients diagnosed with cutaneous lupus erythematosus and plaque psoriasis.

  10. The Cutaneous Lupus Activity-Investigator Global Assessment (CLA-IGA)

    Time frame: Baseline - month 12

    The Cutaneous Lupus Activity-Investigator Global Assessment (CLA-IGA) is a validated clinician-reported outcome measure used to assess overall disease activity in patients with cutaneous lupus erythematosus. The scale ranges from 0 to 5, where 0 indicates no disease activity and 5 reflects very severe disease. Higher scores correspond to greater clinical severity.

    The CLA-IGA will be assessed only in patients with cutaneous lupus erythematosus.

  11. International Hidradenitis Suppurativa Severity Score System (IHS4)

    Time frame: Baseline - month 12

    The International Hidradenitis Suppurativa Severity Score System (IHS4) is a validated clinician-reported outcome measure used to assess the severity of hidradenitis suppurativa. The total IHS4 score is calculated based on the number of nodules, abscesses, and draining tunnels, with no fixed maximum but typically ranging from 0 upwards. Higher scores indicate more severe disease activity, while a score of 0 reflects no active disease.

    The IHS4 score will be assessed only in patients with hidradenitis suppurativa.

  12. Modified Severity-Weighted Assessment Tool (mSWAT)

    Time frame: Baseline - month 12

    The Modified Severity-Weighted Assessment Tool (mSWAT) is a clinician-reported outcome measure used to assess the severity and extent of Cutaneous T-Cell Lymphoma, specifically Mycosis Fungoides. The total mSWAT score ranges from 0 to 360, with higher scores indicating more severe disease involvement. A score of 0 reflects no active disease.

    The mSWAT score will be assessed only in patients with Cutaneous T-Cell Lymphoma subtype Mycosis Fungoides.

  13. Cutaneous Lymphoma Activity and Severity Index (CAILS)

    Time frame: Baseline - month 12

    The Cutaneous Lymphoma Activity and Severity Index (CAILS) is a clinician-reported outcome measure used to evaluate disease activity and severity in patients with Cutaneous T-Cell Lymphoma, including Mycosis Fungoides. The total CAILS score ranges from 0 to 70, with higher scores indicating greater disease severity. A score of 0 corresponds to no active disease.

    The CAILS score will be assessed only in patients with Cutaneous T-Cell Lymphoma subtype Mycosis Fungoides.

  14. Psoriasis Area and Severity Index (PASI)

    Time frame: Baseline - month 12

    The Psoriasis Area and Severity Index (PASI) is a validated clinician-reported outcome measure used to assess the severity and extent of plaque psoriasis. The total PASI score ranges from 0 to 72, with higher scores indicating more severe disease. A score of 0 represents no psoriasis involvement.

    The PASI score will be assessed only in patients with psoriasis.

  15. Physician Global Assessment (PGA)

    Time frame: Baseline - month 12

    The Physician Global Assessment (PGA) for Psoriasis is a validated clinician-reported outcome measure used to assess the overall severity of psoriasis, including all clinical forms. The PGA score typically ranges from 0 to 6, depending on the specific scale used, with higher scores indicating more severe disease. A score of 0 represents clear skin with no signs of psoriasis.

    The PGA score will be assessed only in patients with psoriasis.

  16. Body Surface Area (BSA)

    Time frame: Baseline - month 12

    The Body Surface Area (BSA) is a clinician-reported measure used to estimate the percentage of the body affected by psoriasis. The score ranges from 0% to 100%, where 0% indicates no skin involvement and 100% represents the entire body surface affected. Higher BSA values correspond to more extensive disease.

    The BSA will be assessed only in patients with psoriasis.

  17. Psoriasis Area and Severity Index - High Discrimination (PASI-HD)

    Time frame: Baseline - month 12

    The Psoriasis Area and Severity Index - High Discrimination (PASI-HD) is a clinician-reported outcome measure designed to provide enhanced sensitivity and precision in assessing the severity and extent of psoriasis. The score ranges from 0 to 72, where 0 indicates no disease activity and 72 represents the most severe possible presentation. Higher scores correspond to more severe disease.

    The PASI-HD will be assessed only in patients with psoriasis.

Secondary outcomes

  1. User experience and subjective burden questionnaire

    Time frame: Baseline, month 6

    Measures the user experience and subjective burden of the different assessments performed in this study.

  2. Patient reported outcomes

    Time frame: Baseline - month 12

    Patients will be asked to report on the impact of their skin disease on different aspects of their lives, with the following questionnaires: DLQI, TSQM, HADS< NRS pruritus and burning sensation/pain, 5-D itch scale, ISDL, ISBQ, PSWQ, ISDL, expectancies and avoidance behaviour, G-EEE, SQSQ-S, DS-14. The following questionnaires are optional: PSS, P-scale short, and SEMCD. The following disease specific patient reported outcomes are measured: RECAP, POEM, AAS7, UAS7, UCT, HiSQoL.

  3. Skin barrier function by Electrical Impedance Spectroscopy (EIS)

    Time frame: Baseline - month 12

    The barrier status by trans epidermal water loss of (non-)lesional skin and healthy skin will be determined using EIS.

  4. Line-Field Confocal Optical Coherence Tomography (LC-OCT)

    Time frame: Baseline - month 12

    LC-OCT is a non-invasive optical imaging technique based on a combination of the optical principles of optical coherence tomography and reflectance confocal microscopy with line-field illumination, which can generate cell-resolved images of the skin, in vivo, in vertical section, horizontal section and in three dimensions.

  5. Laser Speckle Contrast Imaging (LSCI)

    Time frame: Baseline - month 12

    The cutaneous microcirculation of (non-)lesional skin sites and healthy skin will be monitored over a 40 second timespan with a laser speckle contrast imager.

  6. 3D Multispectral imaging

    Time frame: Baseline - month 12

    The redness and superficial morphology of (non-)lesional skin sites and healthy skin will be determined using a 3D multispectral imaging system.

  7. Colorimetry

    Time frame: Baseline - month 12

    The redness and surface characteristics of (non-)lesional and healthy skin will be assessed using a colorimetry device that quantitatively measures skin color parameters, including erythema, based on reflected light.

  8. Skin punch biopsies

    Time frame: Baseline, month 3

    Skin punch biopsies (4mm) will be taken from (non-)lesional skin and healthy for histology, tissue mass cytometry (CyTOF) and RNA-sequencing analysis.

  9. Patient genotyping

    Time frame: Baseline

    A whole blood sample will be used to scan for common mutations in genes implicated in psoriasis using next-generation sequencing.

  10. Activity Tracking Sleep

    Time frame: Baseline - month 6

    Subjects are requested to wear a smartwatch at all times which register sleep (hrs, minutes, seconds of rest)

  11. Activity Tracking Steps

    Time frame: Baseline - month 6

    Subjects are requested to wear a smartwatch at all times which register steps (amount of steps taken)

  12. Activity Tracking Heartrate

    Time frame: Baseline - month 6

    Subjects are requested to wear a smartwatch at all times which heart rate (beats per minute)

  13. Blood sampling for RNAsequencing

    Time frame: Baseline, month 3

    Blood will be drawn during using a venipuncture during visits and analyzed with RNAsequencing.

  14. Dermatology Life Quality Index (DLQI)

    Time frame: Baseline - month 12

    The Dermatology Life Quality Index (DLQI) is a validated patient-reported outcome measure that assesses the impact of skin diseases on patients' quality of life over the previous week. The total DLQI score ranges from 0 to 30, with higher scores indicating greater impairment in quality of life. A score of 0 reflects no impact, whereas 30 represents the most severe impact on quality of life.

    The DLQI will be assessed in all patients across the included skin disease cohorts.

  15. Treatment Satisfaction Questionnaire for Medication (TSQM)

    Time frame: Month 3 - month 12

    The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated patient-reported outcome measure designed to assess patients' satisfaction with their medication. The TSQM evaluates multiple domains including effectiveness, side effects, convenience, and overall satisfaction. Scores for each domain range from 0 to 100, with higher scores indicating greater satisfaction.

    The TSQM will be assessed in all patients across the included skin disease cohorts.

  16. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline - month 12

    The Hospital Anxiety and Depression Scale (HADS) is a validated patient-reported outcome measure used to assess levels of anxiety and depression symptoms. It consists of two subscales: Anxiety (HADS-A) and Depression (HADS-D), each ranging from 0 to 21. Higher scores indicate greater severity of anxiety or depression symptoms.

    The HADS will be assessed in all patients across the included skin disease cohorts.

  17. Numerical Rating Scale (NRS) for Pruritus and Burning Sensation/Pain

    Time frame: Baseline - month 12

    The Numerical Rating Scale (NRS) for Pruritus and Burning Sensation/Pain are validated patient-reported outcome measures used to assess the intensity of itch and burning pain, respectively. Both scales range from 0 to 10, where 0 indicates no symptom and 10 represents the worst imaginable symptom. Higher scores correspond to greater symptom severity.

    The NRS for pruritus and burning sensation/pain will be assessed in all patients across the included skin disease cohorts.

  18. 5-D Itch Scale

    Time frame: Baseline - month 12

    The 5-D Itch Scale is a patient-reported outcome measure designed to assess the multidimensional impact of pruritus (itching). It evaluates five domains: Duration, Degree, Direction, Disability, and Distribution of itch. The total score ranges from 5 to 25, with higher scores indicating greater severity and impact of itch. A score of 5 reflects no itch symptoms, whereas 25 represents the most severe and disabling itch experience.

    The 5-D Itch Scale will be assessed in all patients.

  19. Chronic Skin Disease on Daily Life (ISDL)

    Time frame: Baseline - month 12

    The Chronic Skin Disease on Daily Life (ISDL) is a patient-reported outcome measure designed to evaluate the impact of chronic skin diseases on patients' daily lives. The total score ranges from 0 to 40, with higher scores indicating a greater negative impact on daily functioning and quality of life. A score of 0 reflects no impact, while 40 represents the most severe impairment.

    The ISDL will be assessed in all patients.

  20. Itch Severity and Burden Questionnaire (ISBQ)

    Time frame: Baseline - month 12

    The Itch Severity and Burden Questionnaire (ISBQ) is a validated patient-reported outcome measure designed to assess the psychosocial burden and emotional impact of chronic itch. The total score ranges from 0 to 20, with higher scores reflecting a greater negative impact on emotional wellbeing and daily functioning. A score of 0 indicates no emotional burden, while a score of 20 indicates a very high burden related to chronic itch.

    The ISBQ will be assessed in all patients.

  21. Penn State Worry Questionnaire (PSWQ)

    Time frame: Baseline - month 12

    The Penn State Worry Questionnaire (PSWQ) is a validated patient-reported outcome measure designed to assess the tendency toward excessive, uncontrollable, and generalized worry, which is a key feature of generalized anxiety disorder but may also occur in other chronic conditions.

    The total PSWQ score ranges from 16 to 80, with higher scores indicating greater levels of pathological worry. A score of 16 reflects minimal worry, while a score of 80 reflects a high tendency to worry excessively.

    The PSWQ will be assessed in all patients.

  22. Impact of Chronic Skin Disease on Daily Life (ISDL)

    Time frame: Baseline - month 12

    The Impact of Chronic Skin Disease on Daily Life (ISDL) is a validated patient-reported outcome measure specifically designed to assess the impact of chronic skin conditions on various aspects of daily functioning and quality of life.

    The ISDL consists of multiple domains, including symptoms, emotional burden, daily activities, social functioning, and treatment-related burden. The total score ranges from 0 to 100, with higher scores indicating a greater impact and thus a worse outcome.

    The ISDL will be assessed in all patients.

  23. Expectancies and and avoidance behaviour (G-EEE)

    Time frame: Baseline - month 12

    The Expectancies and Avoidance Behaviour Questionnaire (G-EEE) is a validated patient-reported outcome measure used to assess symptom-related expectancies and avoidance behaviour in individuals with chronic skin conditions. The total score reflects the degree to which patients expect their symptoms to worsen due to certain triggers (e.g. scratching, sweating, stress) and the extent to which they engage in avoidance behaviour as a result. Higher scores indicate stronger avoidance behaviour and more negative symptom-related expectancies. The G-EEE will be assessed in all patient groups.

  24. Social Sensory Processing Questionnaire - Short Form (SPSQ-S)

    Time frame: Baseline - month 12

    The Social Sensory Processing Questionnaire - Short Form (SPSQ-S) is a patient-reported outcome measure designed to assess individual sensitivity to sensory stimuli in social environments. It evaluates how patients perceive and react to social sensory input that may cause discomfort or stress. The questionnaire consists of a series of items scored on a Likert scale, with higher scores indicating greater sensitivity. The SPSQ-S will be assessed in all patient groups.

  25. Type D Personality Scale (DS-14)

    Time frame: Baseline - month 12

    The Type D Personality Scale (DS-14) is a self-reported questionnaire used to identify the presence of a distressed personality type, characterized by high levels of negative affectivity and social inhibition. It consists of 14 items scored on a Likert scale, with higher scores indicating stronger Type D personality traits. The DS-14 will be assessed in all patient groups.

  26. Perceived Stress Scale (PSS)

    Time frame: Baseline - month 12

    The Perceived Stress Scale (PSS) is a self-reported questionnaire designed to measure the perception of stress. It assesses how unpredictable, uncontrollable, and overloaded respondents find their lives. The PSS consists of 10 items scored on a Likert scale, with higher scores indicating higher perceived stress levels. The PSS will be assessed in all patient groups.

  27. P-Scale Short

    Time frame: Baseline - month 12

    The P-Scale Short is a self-reported questionnaire measuring perceived stigma related to chronic illness. It consists of a brief set of items, with higher scores indicating greater experienced stigma. The P-Scale Short will be assessed in all patient groups.

  28. Self-Efficacy for Managing Chronic Disease (SEMCD) scale

    Time frame: Baseline - month 12

    The Self-Efficacy for Managing Chronic Disease (SEMCD) scale is a validated patient-reported outcome measure designed to assess an individual's confidence in their ability to manage symptoms, maintain function, and cope with the emotional and social consequences of chronic diseases. The SEMCD typically consists of multiple items rated on a numerical scale, with higher scores indicating greater self-efficacy and perceived ability to control one's chronic condition. This measure is important for understanding patient empowerment and adherence to treatment plans. The SEMCD will be assessed in all patient groups included in the study.

  29. Recap of Atopic Eczema (RECAP)

    Time frame: Baseline - month 12

    The Recap of Atopic Eczema (RECAP) is a validated patient-reported outcome measure designed to assess disease control over the past week in patients with atopic dermatitis. It consists of a concise set of questions that capture symptoms, impact on daily life, and treatment effectiveness. Scores range from 0 to 30, with higher scores indicating poorer disease control. The RECAP will be assessed only in patients with atopic dermatitis.

  30. Patient-Oriented Eczema Measure (POEM)

    Time frame: Baseline - month 12

    The Patient-Oriented Eczema Measure (POEM) is a validated patient-reported outcome measure used to assess the severity of atopic dermatitis symptoms over the past week. The questionnaire consists of seven items addressing the frequency of key symptoms such as itching, sleep disturbance, and skin dryness. POEM scores range from 0 to 28, with higher scores indicating more severe disease symptoms. The POEM will be assessed only in patients with atopic dermatitis.

  31. Angioedema Activity Score over 7 days (AAS7)

    Time frame: Baseline - month 12

    The Angioedema Activity Score over 7 days (AAS7) is a validated patient-reported outcome measure that captures the severity and frequency of angioedema symptoms during the preceding week. Scores range from 0 to 105, with higher scores indicating greater disease activity and symptom burden. The AAS7 is used exclusively in patients with chronic spontaneous urticaria (CSU) who experience angioedema to monitor short-term disease activity and treatment response.

  32. Urticaria Activity Score over 7 days (UAS7)

    Time frame: Baseline - month 12

    The Urticaria Activity Score over 7 days (UAS7) is a validated patient-reported outcome measure used to assess the severity and frequency of urticaria symptoms-specifically wheals (hives) and pruritus (itch)-over the previous week. Scores range from 0 to 42, with higher scores reflecting more severe disease activity. The UAS7 is applied exclusively in patients with chronic spontaneous urticaria (CSU) to monitor disease burden and evaluate treatment response.

  33. Urticaria Control Test (UCT)

    Time frame: Baseline - month 12

    The Urticaria Control Test (UCT) is a validated patient-reported outcome measure used to assess disease control in patients with chronic spontaneous urticaria (CSU). The total UCT score ranges from 0 to 16, with higher scores indicating better disease control. This questionnaire is used exclusively in patients with CSU to monitor treatment response and disease management over time.

  34. Hidradenitis Suppurativa Quality of Life (HiSQoL)

    Time frame: Baseline - month 12

    The Hidradenitis Suppurativa Quality of Life (HiSQoL) questionnaire is a validated patient-reported outcome measure designed to assess the impact of hidradenitis suppurativa (HS) on patients' quality of life. The total HiSQoL score ranges from 0 to 66, with higher scores indicating greater impairment and worse quality of life. The questionnaire is specifically used in patients with HS to evaluate the burden of disease and monitor changes over time.

Study contacts

Contact information is provided by the study sponsor or research team.

Martijn van Doorn, MD, PhD

CONTACT

[email protected]

+31 10 704 0704

Robert Rissmann, Professor

CONTACT

[email protected]

+31 71 526 9111

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • Amsterdam University Medical Center
  • Centre for Human Drug Research, Netherlands
  • Erasmus Medical Center
  • Maastricht University Medical Center
  • Radboud University Medical Center
  • UMC Utrecht
  • University Medical Center Groningen

Registry information

Official study title

A Prospective, Multi-Center, Observational Biomarker Real-World Evidence Study for In-Depth Profiling of Patients With Chronic Immune-Mediated Inflammatory Skin Diseases in Daily Practice

Acronym: SKINERGY

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jun 15, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.