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.
Conditions:
🦠 Atopic Dermatitis
🗓️ Study Start (Actual) 30 November 2020
🗓️ Primary Completion (Estimated) 15 March 2027
✅ Study Completion (Estimated) 15 September 2027
👥 Enrollment (Estimated) 111
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

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

    Exclusion Criteria:

    • 1. Enrollment in another clinical trial
    • 2. Hypersensitivity to an agent used for the skin decolonization protocol
    • 3. Use within 4 weeks of systemic treatment with immunosuppressive/immunomodulating drugs (corticosteroids, cyclosporine, mycophenolate, JAK inhibitors, azathioprine, methotrexate)
    • 4. Phototherapy for AD within 4 weeks
    • 5. Treatment with biologics (dupilumab, omalizumab, benralizumab, etc) within sixteen weeks
    • 6. Use of topical steroids, topical calcineurin inhibitors or crisaborale within 7 days
    • 7. Bleach baths within 7 days of the first Visit
    • 8. Use of oral or topical antibiotics within 21 days of the beginning of the study
    • 9. Asthmatics receiving more than 500 μg per day of inhaled corticosteroids
    • 10. History of (HIV, hepatitis B, hepatitis C, tuberculosis malignancy
    • 11. Skin comorbidities that may interfere with assessments: psoriasis, cutaneous T Cell lymphoma,,
    • 12. Severe ongoing medical illnesses e.g. cardiovascular, renal disease, autoimmune disease.
    • 13. Febrile illness at time of visits
    • 14. Suspected immune deficiency or family history of primary immunodeficiency
Ages Eligible for Study: 6 Years to 65 Years (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 29 June 2020
  • First Submitted that Met QC Criteria 1 July 2020
  • First Posted 2 July 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 April 2024
  • Last Update Posted 18 April 2024
  • Last Verified April 2024