Investigating the role of a genetic variant in worsening atopic dermatitis
Mechanisms of Increased Disease Severity in AD Patients With the IL-4Ra R576 Polymorphism
This study is trying to see if a specific genetic change is connected to worse atopic dermatitis in people aged 6 to 65.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 111 (estimated) |
| Ages | 6 Years to 65 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Drugs / interventions | dupilumab, omalizumab, benralizumab, methotrexate |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04455906 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine if the IL-4Ra R576 polymorphism is linked to increased severity of atopic dermatitis in patients. Participants aged 6 to 65 years with a confirmed diagnosis of atopic dermatitis will undergo a single visit for assessments, including questionnaires, blood draws, skin swabs, and biopsies. The study will analyze clinical, immunological, and microbial markers to understand the disease's activity better. The findings could provide insights into the genetic factors influencing atopic dermatitis severity.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 6 to 65 years diagnosed with atopic dermatitis.
Not a fit: Patients currently enrolled in other clinical trials or those with specific skin comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of atopic dermatitis based on genetic factors.
How similar studies have performed: Other studies have explored genetic factors in atopic dermatitis, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Wanda Phipatanakul, MD. MS. — Boston Children's Hospital
- Study coordinator: Rachel Dabek, MD. MPH.
- Email: asthma@childrens.harvad.edu
- Phone: 857-218-5336
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.