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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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational (Non-Interventional) Registry | Other | This is an observational (non-interventional) registry |
| 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 |
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Inclusion Criteria:
To be eligible to participate in this registry, an individual must meet all of the following criteria:
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
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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)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cathy Cheney | Contact | +1 508 408 5433 | corevitasregistrytrials@corevitas.com |
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| ID | Term |
|---|---|
| D012042 | Registries |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D011996 | Records |
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| D009934 |
| Organization and Administration |
| D006298 | Health Services Administration |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |