Status:
RECRUITING
Mechanisms of Increased Disease Severity in AD Patients With the IL-4Ra R576 Polymorphism
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
6-65 years
Brief Summary
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 dermati...
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 qu...
Eligibility Criteria
Inclusion
- Male or female participants ≥6 to 65 yrs of age
- Meet AD Standard Diagnostic Criteria
Exclusion
- 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
Key Trial Info
Start Date :
November 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 15 2027
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT04455906
Start Date
November 30 2020
End Date
September 15 2027
Last Update
April 18 2025
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115