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

NCT04455906 | Recruiting

• 1 other identifier: IRB-P00035467
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• atopic dermatitis severity

  validated assessment EASI score

  baseline, only 1 time point

Eligibility Criteria

• Age: 6 Years - 65 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

atopic dermatitis

You may qualify if:

• Male or female participants ≥6 to 65 yrs of age
• Meet AD Standard Diagnostic Criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, skin tape, biopsy

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Wanda Phipatanakul, MD. MS.

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Dabek, MD. MPH.

CONTACT

857-218-5336; asthma@childrens.harvad.edu

Hannah Foster

CONTACT

857-218-3819; asthma@childrens.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics, Director Asthma Research Center

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: November 30, 2020
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: April 18, 2025

Record last verified: 2025-04

Locations

US (1)