Registry for Systemic Eczema Treatments (RESET)

Johns Hopkins University

Status: Enrolling

Conditions: Atopic Dermatitis

Study type: Observational

Funder types: Other

Identifiers

NCT06136767

IRB00372852

Details and patient eligibility

About

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 treatment(s) 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.

Full 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 treatment(s) 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 U.S. Food and Drug Administration (FDA)-approved systemic therapies for AD.

Enrollment: 400 estimated patients

Sex: All

Ages: 1 to 26 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age <26 years old
• Current physician diagnosis of atopic dermatitis
• Provide signed informed consent if ≥ 18 years old
• Provide signed informed consent by parent or legal guardian (if <18 years old) and informed assent if applicable
• Subject and/or parent/legal guardian is willing to be contacted in the future by study staff
• Seen for clinical care at Johns Hopkins since 1/1/2017
• Previously on, currently on, or planning to initiate (within next 6 months) a systemic AD therapy

Exclusion criteria

• Age ≥26 years old at the time of registry enrollment
• Does not speak English
• If <18 years old, has a primary caretaker who does not speak English
• If <18 years old, parent/legal guardian is unwilling to sign the written informed consent
• Is a foster child
• Has not received clinical care at Johns Hopkins since 1/1/2017

Trial design

400 participants in 8 patient groups

Methotrexate

Description:

Participants who have received methotrexate for atopic dermatitis.

Cyclosporine

Description:

Participants who have received cyclosporine for atopic dermatitis.

Mycophenolate mofetil

Description:

Participants who have received mycophenolate mofetil for atopic dermatitis.

Azathioprine

Description:

Participants who have received azathioprine for atopic dermatitis.

Dupilumab

Description:

Participants who have received dupilumab for atopic dermatitis.

Tralokinumab

Description:

Participants who have received tralokinumab for atopic dermatitis.

Upadacitinib

Description:

Participants who have received upadacitinib for atopic dermatitis.

Abrocitinib

Description:

Participants who have received abrocitinib for atopic dermatitis.