Actively Recruiting
SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)
Led by Leiden University Medical Center · Updated on 2025-08-19
840
Participants Needed
8
Research Sites
230 weeks
Total Duration
On this page
Sponsors
L
Leiden University Medical Center
Lead Sponsor
E
Erasmus Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent
- Male or non-pregnant female aged 18 years or older
- Willing to avoid extensive washing of target lesional skin 12 hours before study visits
- Willing and able to comply with study protocol
- Female participants willing to avoid pregnancy from study entry to last visit
- Willing to start prescribed treatment
- For atopic dermatitis: diagnosed with chronic moderate-to-severe AD for at least 3 years, eligible for immunosuppressants, biologics, or JAK inhibitors, EASI score 7 or higher, and intention to start specified treatments
- For cutaneous lupus erythematosus: confirmed diagnosis, CLASI-A score 3 or higher, intention to start topical corticosteroids, hydroxychloroquine, or methotrexate
- For chronic spontaneous urticaria: diagnosis of moderate to severe CSU for at least 3 months, symptomatic despite antihistamines, stable antihistamine dose if applicable, intention to start omalizumab, cyclosporine A, or BTK inhibitor
- For hidradenitis suppurativa: history of moderate-to-severe HS for at least 1 year, eligible to start systemic treatment including anti-TNF or anti-IL17
- For mycosis fungoides: confirmed diagnosis with at least one patch or plaque lesion, intention to start topical or phototherapy treatment
- For psoriasis: diagnosed with chronic plaque psoriasis for at least 6 months, PASI score 5 or higher, eligible to start systemic biologic treatments
- Healthy volunteers: aged 18 or older, stable good health, no significant skin disease, willing to comply with study requirements
You will not qualify if you...
- Presence of other relevant skin infection or disease in treatment area
- Treatment with non-marketed drugs within 4 weeks prior to baseline
- Any condition or factor interfering with study conduct or objectives
- Recent treatments with specific washout periods preferred for topical, phototherapy, systemic, radiotherapy, biologics, or chemotherapy
- For CLE patients: diagnosis of systemic lupus erythematosus
- For CSU patients: recent omalizumab treatment within 8 weeks, other urticarial or angioedema conditions
- For MF patients: ongoing uncontrolled active skin infection other than secondary impetiginized CTCL lesions
- For psoriasis patients: primarily erythrodermic, pustular, or guttate psoriasis, or drug-induced psoriasis
- Healthy volunteers: history of immunological abnormalities, uncontrolled significant diseases, recent systemic antibiotic or immunosuppressive therapy, recent blood loss or donation, recent investigational drug study participation, excessive alcohol use, positive drug test or abuse history, recent high UV exposure, recent extreme physical activities, or other interfering conditions
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands, 6525GA
Not Yet Recruiting
2
Maastricht University Medical Center+
Maastricht, Limburg, Netherlands, 6229HX
Not Yet Recruiting
3
Amsterdam University Medical Center
Amsterdam, North Holland, Netherlands, 1105AZ
Not Yet Recruiting
4
University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands, 9713GZ
Not Yet Recruiting
5
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333 ZA
Not Yet Recruiting
6
Centre for Human Drug Research
Leiden, South Holland, Netherlands, 2333CL
Not Yet Recruiting
7
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015GD
Not Yet Recruiting
8
University Medical Center Utrecht
Utrecht, Utrecht, Netherlands, 3584 CX
Actively Recruiting
Research Team
R
Robert Rissmann, Professor
CONTACT
M
Martijn van Doorn, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
18
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