NCT04455906 Mechanisms of Increased Disease Severity in AD Patients With the IL-4Ra R576 Polymorphism
| NCT ID | NCT04455906 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Children's Hospital |
| Condition | Atopic Dermatitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 111 participants |
| Start Date | 2020-11-30 |
| Primary Completion | 2027-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 111 participants in total. It began in 2020-11-30 with a primary completion date of 2027-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Wanda Phipatanakul, MD. MS.
PRINCIPAL INVESTIGATOR
Boston Children's Hospital
Frequently Asked Questions
Who can join the NCT04455906 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 65 Years, studying Atopic Dermatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04455906 currently recruiting?
Yes, NCT04455906 is actively recruiting participants. Contact the research team at asthma@childrens.harvad.edu for enrollment information.
Where is the NCT04455906 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT04455906 clinical trial?
NCT04455906 is sponsored by Boston Children's Hospital. The principal investigator is Wanda Phipatanakul, MD. MS. at Boston Children's Hospital. The trial plans to enroll 111 participants.
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