Recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT06136767

Conditions

Atopic Dermatitis

Eligibility Criteria

Sex: All

Age: 1 - 26

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Atopic Dermatitis

Study ID

NCT06136767

Start date

Jan 17, 2024

Status verified date

Apr, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Aug 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 26

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Methotrexate

Participants who have received methotrexate for atopic dermatitis.

Cyclosporine

Participants who have received cyclosporine for atopic dermatitis.

Mycophenolate mofetil

Participants who have received mycophenolate mofetil for atopic dermatitis.

Azathioprine

Participants who have received azathioprine for atopic dermatitis.

Dupilumab

Participants who have received dupilumab for atopic dermatitis.

Tralokinumab

Participants who have received tralokinumab for atopic dermatitis.

Upadacitinib

Participants who have received upadacitinib for atopic dermatitis.

Abrocitinib

Participants who have received abrocitinib for atopic dermatitis.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Zeena Mestari, BA

1 (848) 702-4101‬zmestar1@jh.edu

Rebecca Urbonas, BS

813-300-1317rurbona1@jh.edu

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21218

Contacts

Zeena Mestari, BA

848-702-4101Zmestar1@jh.edu

Principal Investigator:

Joy Wan, MD MSCE

More Information

Sponsor

Johns Hopkins University

Last update posted

Apr 7, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-28. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-04-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.