A Multi-Center Observational Study Profiling Biomarkers in Adults with Six Chronic Immune-Mediated Inflammatory Skin Diseases

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-IL413 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.

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