Study to Understand Chronic Inducible Urticaria Types Symptomatic Dermographism and Cold Urticaria and Explore New Biomarkers by Comparing with Chronic Spontaneous Urticaria and Healthy Volunteers

What this Trial Is About

Researchers are investigating chronic inducible urticaria CIndU, a group of skin disorders characterized by recurring itchy or burning wheals and angioedema triggered by specific factors. This study focuses on two common subtypes symptomatic dermographism SD and cold urticaria ColdU. The aim is to better understand these subtypes by identifying new biomarkers to improve diagnosis and treatment monitoring, as current methods rely mainly on patient history and clinical appearance without many objective tools. The study has two parts Part A involves detailed biological analysis to characterize disease features and mechanisms in SD and ColdU patients. Part B monitors changes in these biomarkers during treatment with omalizumab, administered every four weeks. The study includes 30 patients divided among chronic spontaneous urticaria CSU, SD, and ColdU groups receiving omalizumab, and 10 healthy volunteers as controls. Participants will undergo various assessments including blood tests, skin imaging, molecular analyses, and microbiome evaluations from baseline up to day 99. Patient-reported outcomes and activity tracking will also be used to evaluate disease activity and quality of life. This comprehensive monitoring aims to provide objective measures of disease status and response to treatment over the study period.

Deep Phenotyping of CIndU