PPDTM CorEvitasTM Chronic Hand Eczema (CHE) Drug Safety and Effectiveness Registry

The design is a prospective, observational registry for subjects with CHE under the care of dermatology or other qualified healthcare provider. Longitudinal data are collected from both subjects and their treating provider during routine clinical encounters using a structured and standardized data collection method

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Hand Eczema
• Intervention / Treatment: Other: Observational (Non-Interventional) Registry

Detailed Description

The objective of the registry is to create a cohort of CHE subjects to evaluate long-term real world safety and effectiveness of standard of care treatments for CHE. Data collected through the registry may be used to address a range of research questions and use cases, including but not limited to: characterizing the natural history of the disease, evaluating the effectiveness and safety of commercially available medications for the treatment of CHE, providing information to support ongoing risk-benefit evaluation by drug manufacturers and regulators, and research related to drug utilization, disease burden, and unmet needs. Further, data collected will inform clinical decision making by patients and treating providers.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Cathy Cheney; Phone Number: +1 508 408 5433; Email: corevitasregistrytrials@corevitas.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Subjects enrolled in this registry will be treated according to routine clinical care; treatments are prescribed at the provider's discretion and the decision to treat the subject with a drug is made prior to and independently of study participation. The clinician will determine subject visit schedules according to routine practice, patient needs, and local standard of care (SoC)

Description

Inclusion Criteria:

• To be eligible to participate in this registry, an individual must meet all of the following criteria:

  1. Diagnosed with moderate-to-severe CHE by a dermatologist or other qualified healthcare provider at the time of enrollment and initiating an eligible medication.
  2. Is at least 18 years of age or older and has attained the legal age for consent to procedures involved in the research, under the applicable law of the jurisdiction in which the research is being conducted at the time of enrollment
  3. Is willing and able to consent to participation in the registry
  4. Is willing and able to complete registry-related forms electronically via personal devices.
  5. Is willing and able to provide the information (first name, last name, email address, language and primary time zone) required to create an account to allow you to complete registry forms via a personal device;
  6. Is willing and able to provide Personal Information (full legal name, sex, date of birth, home address zip or postal code and email address or phone number at a minimum) if required based on registry location and applicable laws and regulations.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in the registry:

1) Is participating or planning to participate in a blinded clinical trial for a CHE drug

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CHE Disease Epidemiology and presentation	The major clinical outcome include an assessment of the epidemiology of CHE Disease; to better understand the presentation and natural history.	Every 6 months for 10 years
CHE Disease management, and outcomes	The major clinical outcome include an assessment of the epidemiology of CHE Disease; to better understand the management and outcomes.	Every 6 months for 10 years

Collaborators and Investigators

• Sponsor: CorEvitas

Study record dates

Study Major Dates

• Study Start (Estimated): May 29, 2026
• Primary Completion (Estimated): December 31, 2099
• Study Completion (Estimated): December 31, 2099

Study Registration Dates

• First Submitted: May 13, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organization and Administration; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Records; Registries
• Other Study ID Numbers: CorEvitas-CHE-515

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No