Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06136767
Status:
RECRUITING
Last Update Posted:
2024-01-19
First Post:
2023-11-06
Brief Title:
Registry for Systemic Eczema Treatments
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Registry for Systemic Eczema Treatments
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESET
Brief Summary:
The Registry for Systemic Eczema Therapies RESET registry is a database and biospecimen repository for patients with pediatric-onset atopic dermatitis AD who have used or will initiate any systemic treatments for AD The goal of the registry is to enable more efficient research recruitment and data collection as well as timely notification to enrollees about newly FDA-approved treatments for AD
Detailed Description:
The purpose of the Registry for Systemic Eczema Therapies RESET registry is to serve as a database and biospecimen repository of patients with pediatric-onset atopic dermatitis AD also known as eczema This registry seeks to enroll patients with AD who have used or will initiate any systemic treatments for AD Such a registry will allow investigators to identify patients who are potentially eligible for AD research protocols including observational studies or clinical trials The registry will also prospectively collect data that would then serve as a resource for studying a variety of questions surrounding systemic therapy use in patients with AD for example comparing the effectiveness of treatments or examining treatment effects on patient-reported outcomes Moreover the registry would permit safety monitoring of systemic AD medications as it would include both patients receiving traditional systemic agents with well-known side effect profiles and patients receiving more novel systemic agents with under-characterized side effect profiles Finally this registry would allow for the identification of patients with moderate-to-severe AD who may be eligible to receive and benefit from the rapidly expanding number of US Food and Drug Administration FDA-approved systemic therapies for AD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None