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

  • STATUS
    Recruiting
  • End date
    Sep 15, 2027
  • participants needed
    111
  • sponsor
    Boston Children's Hospital
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Updated on 15 June 2022
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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 dermatitis.

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.

Details
Condition Atopic Dermatitis
Clinical Study IdentifierNCT04455906
SponsorBoston Children's Hospital
Last Modified on15 June 2022

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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