RecruitingNCT07021495

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

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


Sponsor

Leiden University Medical Center

Enrollment

840 participants

Start Date

Jul 29, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (SKINERGY) is collecting biological samples and skin measurements from patients with various skin diseases — including eczema (atopic dermatitis), psoriasis, and others — to identify biomarkers that can predict how well people respond to treatment. **You may be eligible if...** - You are 18 or older - You have been diagnosed with a chronic skin condition such as moderate-to-severe atopic dermatitis (eczema) or psoriasis - You are willing to start the prescribed treatment for your skin condition - You agree to avoid thoroughly washing the affected skin area for 12 hours before each study visit **You may NOT be eligible if...** - You are pregnant or planning to become pregnant during the 12-month study period - You have a condition that prevents you from safely participating - You are unable to comply with study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.


Locations(8)

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

Maastricht University Medical Center+

Maastricht, Limburg, Netherlands

Amsterdam University Medical Center

Amsterdam, North Holland, Netherlands

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Leiden University Medical Center

Leiden, South Holland, Netherlands

Centre for Human Drug Research

Leiden, South Holland, Netherlands

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

University Medical Center Utrecht

Utrecht, Utrecht, Netherlands

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07021495


Related Trials