Background: The Dutch flagship project Next Generation ImmunoDermatology (NGID) aims to profile five chronic immune-mediated inflammatory skin diseases: atopic dermatitis (AD), plaque psoriasis (PSO), hidradenitis suppurativa (HS), chronic spontaneous urticaria (CSU) and cutaneous lupus erythematosus (CLE) in comparison with cutaneous T-cell lymphoma subtype mycosis fungoides (MF) and healthy volunteers. Within NGID, a clinical study entitled: 'SKIN disease profiling by an Exploratory, pRospective, biomarker study in dermatoloGY practice (SKINERGY)' will be conducted as a multicentre, parallel-cohort, open-label, observational, longitudinal basket study.
Objectives: Objectives include evaluation of disease-related characteristics in comparison to those of healthy volunteers and evaluation of biomarkers for disease stratification and (targeted) treatment response in patients in a real-world clinical setting. Additionally, differences and similarities in disease characteristics between diseases, changes over time, and profiles of responders versus non-responders will be evaluated.
Methods: Patients with AD (N = 120), PSO (N = 160), HS (N = 80), CSU (N = 120) and CLE (N = 120) will be enrolled in groups of N ≤ 40 patients per treatment. Matched healthy volunteers (N = 120) and the MF cohort (N = 120) will serve as control groups. Assessments include blood sampling, skin punch biopsies, tape stripping, skin swabs, (multimodal) imaging, tele-health and patient- and physician-reported outcomes. This manuscript describes the study protocol prior to data collection and its strategic evaluation of multi-omics profiling. Patient advocacy groups co-defined the research agenda and contributed to study design and informed consent document development, ensuring alignment with patients' needs and real-world relevance.
Results: SKINERGY will generate a machine learning-ready dataset with information about changes in various biomarkers over time, including histology, metabolomics, spatial proteomics, transcriptomics, lipidomics, microbiomics, imaging biomarkers, tele-health, patient-reported outcome measures (PROMs) and clinical parameters.
Conclusion: Identified biomarker profiles within SKINERGY may guide targeted treatment selection, enhance targeted therapeutic response in clinical practice and improve understanding of disease pathology in chronic immune-mediated skin diseases.
Keywords: atopic dermatitis; chronic spontaneous urticaria; cutaneous lupus erythematosus; hidradenitis suppurativa; inflammatory skin diseases; multi‐omics deep phenotyping; mycosis fungoides‐type cutaneous t‐cell lymphoma; personalized medicine; psoriasis.
The SKINERGY study will investigate disease mechanisms of five immune‐mediated inflammatory skin diseases, namely atopic dermatitis, psoriasis, hidradenitis suppurativa, chronic spontaneous urticaria and cutaneous lupus erythematosus. Chronic inflammatory skin conditions are estimated to affect up to 25% of the population. The study is designed to compare mechanisms of these inflammatory skin diseases with an external cohort of patients with cutaneous T‐cell lymphoma subtype mycosis fungoides and healthy volunteers. The SKINERGY study is a nationwide initiative, with patient inclusion occurring across all university medical centres in the Netherlands. The main aim of the SKINERGY study is to generate a harmonized dataset suitable for advanced computer analysis in order to identify biomarkers for disease monitoring and enabling prediction of (non)‐response to treatment. This is an observational study, in which 720 patients will be followed for 1 year after initiating real‐world treatment in routine clinical settings. Several parameters will be assessed at baseline (prior to the first dose), Month 3 and Month 6 (core study). Optional assessments include a 12‐month follow‐up visit, supplementary questionnaires and skin punch biopsies. Additionally, a control group of 120 untreated healthy volunteers will be monitored over a 3‐month period. Ultimately, the study seeks to discover biomarkers that can guide treatment selection, facilitating more precise and personalized treatment strategies for patients with inflammatory skin diseases.
© 2026 The Author(s). Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.