Recruiting

Observational Study

Sponsor:

Boston Children's Hospital

Code:

NCT04455906

Conditions

Atopic Dermatitis

Eligibility Criteria

Sex: All

Age: 6 - 65

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Atopic Dermatitis

Study ID

NCT04455906

Start date

Nov 30, 2020

Status verified date

May, 2026

Completion date

Sep 15, 2027

Anticipated

Primary completion date

Mar 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

111 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • atopic dermatitis severity [ Time Frame: baseline, only 1 time point ]

Central Contacts and Locations

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

More Information

Sponsor

Boston Children's Hospital

Last update posted

May 18, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-05-18.