Mechanisms of Increased Disease Severity in AD Patients With the IL-4Ra R576 Polymorphism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis. Basic parameters: 6 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Primary outcome measures
- atopic dermatitis severity [Time frame: baseline, only 1 time point]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Boston Children's Hospital — Boston
Identifiers
NCT: NCT04455906 · IRB-P00035467