Mechanisms of Increased Disease Severity in AD Patients With the IL-4Ra R576 Polymorphism

Sponsor

Boston Children's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04455906

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

111

Enrollment

Location

81.5

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

111 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Mechanisms of Increased Disease Severity in AD Patients With the IL-4Ra R576 Polymorphism

Actual Study Start Date :

Nov 30, 2020

Anticipated Primary Completion Date :

Mar 15, 2027

Anticipated Study Completion Date :

Sep 15, 2027

Outcome Measures

Primary Outcome Measures

atopic dermatitis severity [baseline, only 1 time point]
validated assessment EASI score

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 65 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston Children's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

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

Investigators

Principal Investigator: Wanda Phipatanakul, MD. MS., Boston Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wanda Phipatanakul, Professor of Pediatrics, Director Asthma Research Center, Boston Children's Hospital

ClinicalTrials.gov Identifier:

NCT04455906

Other Study ID Numbers:

IRB-P00035467

First Posted:

Jul 2, 2020

Last Update Posted:

Jun 7, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dermatitis, Atopic

Dermatitis

Study Results

No Results Posted as of Jun 7, 2022