Atopic DermatitisNCT04455906
Mechanisms of Increased Disease Severity in AD Patients With the IL-4Ra R576 Polymorphism
An observational study of Atopic Dermatitis, run by Boston Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2020to 15 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 65 years
- All sexes
- Child, Adult, Older adult
Study population: atopic dermatitis
Who may be able to join
- Male or female participants ≥6 to 65 yrs of age
- Meet AD Standard Diagnostic Criteria
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Amparito Cunningham, 857-218-5336, asthma@childrens.harvard.edu
About this study
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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
What is being measured
The primary outcome is the main question the study is designed to answer.
atopic dermatitis severity
validated assessment EASI score
Measured: baseline, only 1 time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start30 Nov 2020
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wanda Phipatanakul, Harvard Medical School (HMS and HSDM)
- Investigators
- Wanda Phipatanakul, MD. MS., Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455906
- Sponsor's protocol ID
- IRB-P00035467
- Status last verified
- May 2026
- First submitted
- 29 Jun 2020
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Increased Disease Severity in AD Patients With the IL-4Ra R576 Polymorphism
- ClinicalTrials.gov ID
- NCT04455906
- Acronym / sponsor ID
- IRB-P00035467
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- atopic dermatitis
Key inclusion criteria (2 listed)
- Male or female participants ≥6 to 65 yrs of age
- Meet AD Standard Diagnostic Criteria
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
atopic dermatitis severity
Time frame: baseline, only 1 time point
validated assessment EASI score
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wanda Phipatanakul, MD. MS. principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Dabek, MD. MPH. (857-218-5336, asthma@childrens.harvad.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
atopic dermatitis severity (time frame: baseline, only 1 time point). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.