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NCT Number: NCT04455906

Mechanisms of Increased Disease Severity in AD Patients With the IL-4Ra R576 Polymorphism

This protocol is primarily looking to see if the IL-4Ra R576 polymorphism is associated with increased clinical, immunological and microbial markers of disease activity in patients with Atopic dermatitis.

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Key information

Age range

6 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Amparito Cunningham

CONTACT

[email protected]

857-218-5336

About this study

For this study, participants ages 6-65 years, who have atopic dermatitis and don't have any of the exclusion criteria will be invited to participate in the study. There will be a 1 time visit where questionnaires, blood draw, skin swab and skin biopsies will be performed.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female participants ≥6 to 65 yrs of age
  • Meet AD Standard Diagnostic Criteria

Exclusion criteria

  • Enrollment in another clinical trial
  • Hypersensitivity to an agent used for the skin decolonization protocol
  • Use within 4 weeks of systemic treatment with immunosuppressive/immunomodulating drugs (corticosteroids, cyclosporine, mycophenolate, JAK inhibitors, azathioprine, methotrexate)
  • Phototherapy for AD within 4 weeks
  • Treatment with biologics (dupilumab, omalizumab, benralizumab, etc) within sixteen weeks
  • Use of topical steroids, topical calcineurin inhibitors or crisaborale within 7 days
  • Bleach baths within 7 days of the first Visit
  • Use of oral or topical antibiotics within 21 days of the beginning of the study
  • Asthmatics receiving more than 500 μg per day of inhaled corticosteroids
  • History of (HIV, hepatitis B, hepatitis C, tuberculosis malignancy
  • Skin comorbidities that may interfere with assessments: psoriasis, cutaneous T Cell lymphoma,,
  • Severe ongoing medical illnesses e.g. cardiovascular, renal disease, autoimmune disease.
  • Febrile illness at time of visits
  • Suspected immune deficiency or family history of primary immunodeficiency

Treatment and study plan

Primary outcomes

  1. atopic dermatitis severity

    Time frame: baseline, only 1 time point

    validated assessment EASI score

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah Foster

CONTACT

[email protected]

857-218-3819

Rachel Dabek, MD. MPH.

CONTACT

[email protected]

857-218-5336

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jul 2, 2020
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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