Clinical trial NCT06136767: Registry for Systemic Eczema Treatments
Official title: Registry for Systemic Eczema Treatments
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Dermatitis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Doris Duke Charitable Foundation
First posted: 2023-11-18
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with atopic dermatitis treated with systemic therapy for AD and meet the inclusion criteria will be asked to participate in this registry

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 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.

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

Primary outcomes:
measure: Treatment effectiveness as assessed by the change in Investigator's Global Assessment (IGA) Scores
timeFrame: 3 years
measure: Treatment effectiveness as assessed by the change in Eczema Area and Severity Index (EASI) Scores
timeFrame: 3 years
measure: Treatment effectiveness as assessed by the change in Patient Oriented Eczema Measure (POEM) Scores
timeFrame: Quarterly from baseline to 3 years
measure: Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Itch questionnaire score
timeFrame: Quarterly from baseline to 3 years
measure: Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety questionnaire score
timeFrame: Quarterly from baseline to 3 years
measure: Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Problem questionnaire score
timeFrame: Quarterly from baseline to 3 years
measure: Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depressive Symptoms questionnaire score
timeFrame: Quarterly from baseline to 3 years
measure: Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function questionnaire score
timeFrame: Quarterly from baseline to 3 years
measure: Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health questionnaire score
timeFrame: Quarterly from baseline to 3 years
measure: Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity questionnaire score
timeFrame: Quarterly from baseline to 3 years
Secondary outcomes:
measure: Rate of discontinuation or dose de-escalation of systemic treatment
timeFrame: 3 years
measure: Adverse effects of systemic treatments for atopic dermatitis
timeFrame: 3 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Joy Wan, MD MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.