Mechanisms of Increased Disease Severity in AD Patients With the IL-4Ra R576 Polymorphism
Recruiting · NCT04455906 · Observational (researchers observe without assigning treatment) · Lead sponsor: Boston Children's Hospital
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
6 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed across 1 US state.
- Boston Children's Hospital - Boston, Massachusetts, United States