Investigating the role of a genetic variant in worsening atopic dermatitis
Official title: Mechanisms of Increased Disease Severity in AD Patients With the IL-4Ra R576 Polymorphism
Run by Boston Children's Hospital · NCT04455906 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 6 Years to 65 Years |
| Sex | All |
| Enrollment | 111 (estimated) |
| Sponsor | Boston Children's Hospital Academic / other |
| Drugs / interventions | dupilumab, omalizumab, benralizumab, methotrexate |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | November 30, 2020 |
| Main results expected | March 15, 2027 |
| Study ends | September 15, 2027 |
| Registry record updated | May 18, 2026 |
| Trial ID | NCT04455906 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are males and females aged 6 to 65 years diagnosed with atopic dermatitis.
✕Probably not a fit
Patients currently enrolled in other clinical trials or those with specific skin comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have explored genetic factors in atopic dermatitis, suggesting potential for success in this approach.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Roflumilast Cream 0.3% for moderate to severe atopic dermatitis in children, adolescents, and adults
A cream called roflumilast 0.3% is tested once daily to see if it helps people with moderate to severe atopic dermatitis, compared to a non-medicated cream, across ages 6 and up.
-
Nocturnal ScratchSense ring: test of automatic scratch detection in adults with itchy skin
This study tests whether the Replior ScratchSense ring can accurately detect and measure nighttime scratching in adults with itchy skin conditions.
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ADBest TREAT Registry for adults with atopic dermatitis
A registry in Germany is collecting real-world data from adults with atopic dermatitis to see how treatments are used and how the disease affects quality of life.
-
How lebrikizumab affects the skin microbiome and mycobiome in adults with atopic dermatitis
This study looks at whether lebrikizumab changes the skin bacteria, fungi, and specifically Staphylococcus species, in adults with moderate-to-severe atopic dermatitis.
-
QX-4533 safety study in healthy volunteers and people with moderate-to-severe atopic dermatitis
This study tests the safety and tolerability of QX-4533, given as a pill, in healthy adults and in patients with moderate-to-severe atopic dermatitis to see how the drug behaves in the body and what side effects may occur.
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Tilrekimig for moderate-to-severe eczema in teens and adults
A 52-week study will test tilrekimig against dupilumab and a placebo to see if it helps people 12 and older with moderate-to-severe atopic dermatitis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.