Actively Recruiting
A Prospective, Multi-Center, Observational Biomarker Study Profiling Chronic Immune-Mediated Inflammatory Skin Diseases in Daily Practice
Led by Leiden University Medical Center · Updated on 2025-08-19
840
Participants Needed
8
Research Sites
N/A
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
Researchers are studying six immune-mediated inflammatory skin diseases: 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). This observational study aims to identify and compare biomarkers that distinguish responders from non-responders to treatments, understand differences between patients and healthy volunteers, and explore how biomarkers relate to disease subtypes and treatment outcomes. The study is part of the Next Generation ImmunoDermatology (NGID) initiative, which seeks to develop tools for personalized patient care. Participants will receive standard treatments for their specific skin condition according to national guidelines, including various immunosuppressants, biologics, and targeted therapies such as cyclosporine A, anti-IL4/13 antibodies, JAK1 inhibitors, anti-TNF agents, anti-IL17 therapies, BTK inhibitors, topical corticosteroids, and phototherapy. The study includes different treatment arms for each disease group, and patients will be monitored over one year with scheduled visits and assessments. Healthy volunteers will also be enrolled for baseline comparisons and followed for six weeks. Participants will attend clinic visits combined with their regular care appointments at baseline, month 3, month 6, and optionally month 12. They will complete online questionnaires multiple times during the study, and those with CSU will fill in daily symptom diaries (UAS7 and AAS7). Researchers will collect biological samples, perform imaging and molecular analyses, and evaluate disease severity using various clinical scoring tools. The main outcomes include measuring lipidomics, microbiome, serum and plasma biomarkers, and disease activity scores over 12 months to better understand disease progression and treatment responses.
CONDITIONS
Brief 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 understand and provide written informed consent
- Male or non-pregnant female, 18 years of age or older
- Willing to refrain from extensively washing 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 AD patients: diagnosed with chronic, moderate-to-severe AD for at least 3 years, eligible for immunosuppressants, biologics or JAK-inhibitors, with EASI score ≥7, and intention to start specified treatments
- For CLE patients: confirmed diagnosis with CLASI-A score ≥3, intention to start topical corticosteroids, hydroxychloroquine, or methotrexate
- For CSU patients: diagnosed with moderate-to-severe CSU for ≥3 months, stable antihistamine use if applicable, intention to start omalizumab, cyclosporine A or BTK inhibitor
- For HS patients: history of moderate-to-severe HS for at least 1 year, intention to start anti-TNF or anti-IL17 treatments
- For MF patients: confirmed diagnosis and stage IA-IIA, at least one patch or plaque lesion, intention to start topical chlormethine, corticosteroids, or phototherapy
- For PSO patients: diagnosed with chronic plaque psoriasis for at least 6 months, PASI score ≥5, intention to start specified biologics
- Healthy volunteers: stable good health, no significant skin disease, willing to follow washing and treatment restrictions before visits
You will not qualify if you...
- Other relevant skin infection or disease in treatment area
- Treatment with any non-marketed drug within 4 weeks prior to baseline
- Any condition interfering with study conduct or objectives
- Recent treatments with preferred washout periods not met (topical, phototherapy, systemic, biologics, chemotherapy, radiotherapy, surgery)
- CLE patients diagnosed with systemic lupus erythematosus
- CSU patients treated with omalizumab within 8 weeks prior to baseline or with urticarial/angioedema symptoms such as urticarial vasculitis or mastocytosis
- MF patients with uncontrolled active skin infections (except secondary impetiginized lesions)
- PSO patients with erythrodermic, pustular, guttate, or drug-induced psoriasis
- Healthy volunteers with immunological abnormalities, uncontrolled significant diseases, recent antibiotic or immunosuppressive use, recent significant blood loss, alcohol abuse, drug abuse, UV exposure, extreme physical activities, or other interfering conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 year
Participants are observed while starting and continuing their prescribed standard-of-care treatments for their skin condition. Various clinical, imaging, molecular, and patient-reported data are collected to profile disease and treatment response.
Visits at baseline, month 3, month 6, and month 12
Duration - 6 weeks
Healthy volunteers are observed for comparison over a short period without receiving treatment.
Visits at baseline and follow-up within 6 weeks
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
M
Martijn van Doorn, MD, PhD
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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