Study design of a prospective, observational Chronic Hand Eczema (CHE) registry to describe real-world outcomes of treatments for CHE in the US and Canada

Introduction Chronic Hand Eczema (CHE) is a common inflammatory skin disease of the hands associated with itch and pain. CHE can substantially impair health-related quality of life and contribute to economic burden. The treatment landscape for moderate to severe CHE is evolving, particularly following the 2025 U.S. Food and Drug Administration (FDA) and Health Canada approvals of delgocitinib cream 20 mg/g, a topical pan-Janus kinase inhibitor. Understanding real-world utilization patterns and effectiveness of emerging treatments in clinical practice is important for informing patients, healthcare providers, and payers. We describe the design and structure of the prospective PPDTM CorEvitasTM CHE Registry that aims to generate real-world evidence of patient characteristics, treatment patterns, disease burden, and short- and long-term effectiveness of prespecified treatments for CHE among adults with moderate to severe CHE in the US and Canada. Methods The prospective, longitudinal, observational CorEvitas CHE registry plans to enroll approximately 2,000 adults (aged ≥18 years) with moderate to severe CHE who initiate a prespecified treatment for CHE, including delgocitinib, ruxolitinib, tapinarof, or roflumilast cream; notably, only delgocitinib cream is FDA-approved specifically for moderate to severe CHE. Eligible patients receiving care from dermatologists or other healthcare providers at approximately 60 clinical sites (hospitals, academic medical centers, specialized research centers, and private clinics) across North America who consent to participate will be enrolled and followed longitudinally. Registry enrollment began in July 2026. Data collected from patients and providers include demographics, clinical characteristics, CHE disease features, atopic dermatitis features beyond the hands, comorbidities, healthcare resource utilization, occupational and work exposures, treatment history, concomitant treatments, and over-the-counter hand eczema treatments. Selected laboratory and diagnostic measures are captured, when available, in routine clinical care, including patch testing results. Clinician-reported outcomes include Investigator Global Assessment of CHE and Hand Eczema Severity Index, assessed at enrollment, at follow-up visits approximately every 6 months as permitted by routine care, and at early follow-up visits when a patient initiates a new prespecified treatment for CHE. Patient-reported outcomes include numeric rating scale measures of itch, pain, and sleep, Hand Eczema Impact Scale, Dermatology Life Quality Index, Patient Global Assessment, Work Productivity and Activity Impairment, and DermSat-7 treatment satisfaction. Patient-reported outcomes are collected at enrollment and follow-up visits, with direct-to-patient assessments completed 7 days, 30 days, and every 6 months after enrollment or initiation of a new prespecified treatment for CHE. Treatment information is captured in detail for CHE and related medications, including treatment history, current and new medications, select concomitant medications, and medication start and stop information. Registry data will be used to address a range of research questions, including the disease course following initiation of prespecified treatments for CHE, treatment effectiveness and patterns, unmet needs, and benefit–risk evaluations. Conclusion The prospective CorEvitas CHE Registry is designed to generate real-world evidence of disease burden, treatment patterns, and short- and long-term effectiveness of therapies used for moderate to severe CHE in routine clinical practice, including delgocitinib cream. These data may help characterize unmet needs and inform clinical management and future research on CHE.