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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04455906
Other study ID # IRB-P00035467
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 30, 2020
Est. completion date September 15, 2027

Study information

Verified date April 2024
Source Boston Children's Hospital
Contact Amparito Cunningham, MD. MPH.
Phone 857-218-5336
Email asthma@childrens.harvad.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

For this study, participants ages 6-65 years, who have atopic dermatitis and don't have any of the exclusion criteria will be invited to participate in the study. There will be a 1 time visit where questionnaires, blood draw, skin swab and skin biopsies will be performed.


Recruitment information / eligibility

Status Recruiting
Enrollment 111
Est. completion date September 15, 2027
Est. primary completion date March 15, 2027
Accepts healthy volunteers
Gender All
Age group 6 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
United States Boston Children's Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Boston Children's Hospital National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary atopic dermatitis severity validated assessment EASI score baseline, only 1 time point
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