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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04455906

Enrollment

111

Registered

2020-07-02

Start date

2020-11-30

Completion date

2027-09-15

Last updated

2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

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 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
atopic dermatitis severity	baseline, only 1 time point	validated assessment EASI score

Countries

United States

Contacts

CONTACTRachel Dabek, MD. MPH.

asthma@childrens.harvad.edu857-218-5336

CONTACTHannah Foster

asthma@childrens.harvard.edu857-218-3819

PRINCIPAL_INVESTIGATORWanda Phipatanakul, MD. MS.

Boston Children's Hospital

Outcome results