Registry for Systemic Eczema Treatments

Overview

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.

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 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.

Primary outcome measures

• Treatment effectiveness as assessed by the change in Investigator's Global Assessment (IGA) Scores [Time frame: 3 years]
• Treatment effectiveness as assessed by the change in Eczema Area and Severity Index (EASI) Scores [Time frame: 3 years]
• Treatment effectiveness as assessed by the change in Patient Oriented Eczema Measure (POEM) Scores [Time frame: Quarterly from baseline to 3 years]
• Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Itch questionnaire score [Time frame: Quarterly from baseline to 3 years]
• Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety questionnaire score [Time frame: Quarterly from baseline to 3 years]
• Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Problem questionnaire score [Time frame: Quarterly from baseline to 3 years]
• Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depressive Symptoms questionnaire score [Time frame: Quarterly from baseline to 3 years]
• Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function questionnaire score [Time frame: Quarterly from baseline to 3 years]
• Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health questionnaire score [Time frame: Quarterly from baseline to 3 years]
• Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity questionnaire score [Time frame: Quarterly from baseline to 3 years]

Secondary outcome measures (2)

• Rate of discontinuation or dose de-escalation of systemic treatment [Time frame: 3 years]
• Adverse effects of systemic treatments for atopic dermatitis [Time frame: 3 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 1 center

• Johns Hopkins University — Baltimore

Publications

• Laughter MR, Maymone MBC, Mashayekhi S, Arents BWM, Karimkhani C, Langan SM, Dellavalle RP, Flohr C. The global burden of atopic dermatitis: lessons from the Global Burden of Disease Study 1990-2017. Br J Dermatol. 2021 Feb;184(2):304-309. doi: 10.1111/bjd.19580. Epub 2020 Nov 29. PMID 33006135

Identifiers

NCT: NCT06136767 · IRB00372852

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗