BIOmarkers for the evaluation of patients with DRESS syndrome using skin tape STRIPs: BIO-STRIP study

BIO STRIP is an exploratory study designed to identify potential skin protein biomarkers for the diagnosis and monitoring of patients with Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) using minimally invasive tape strips. The study will investigate the safety of using tape strips and characterise protein differences between affected (lesional) and unaffected (non lesional) skin and compare these with proteins measured in blood samples. Participants with Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), as determined by an Immunologist and Drug Allergy Specialist, will be approached and consented during the acute stage of disease (at diagnosis). Consented participants will undergo biological sampling at baseline (diagnosis), 2 to 4 weeks, and 3 to 6 months after diagnosis. At each time point, the study team will sample tape strips from affected (lesional) and unaffected (non lesional) skin sites, as well as whole blood (40 mL). Tape stripping involves the application of adhesive tape strips to the skin surface, followed by gentle removal to collect superficial layers of the stratum corneum and associated proteins. This will take approximately 10–20 minutes per site. Adherence to the tape stripping procedure will be assessed by the study team during each scheduled visit. The investigator or trained research staff will confirm that tape strip sampling is performed at all planned time points (baseline, 2–4 weeks, and 3–6 months after diagnosis for DRESS participants) and record whether the visit was completed. To maintain fidelity, all study staff will receive training on the tape strip technique, site selection, and documentation.