Atopic DermatitisNCT01782703
Defining the Skin and Blood Biomarkers of Pediatric Atopic Dermatitis
An observational study of Atopic Dermatitis and Eczema, run by Northwestern University at 4 sites in United States.
Trial summary
Atopic dermatitis (AD), also known as eczema, is the most common inflammatory skin disorder of children, affecting 10-20% of children and 1-2% of adults. This skin disorder can be associated with unbearable itchiness and an increased susceptibility to skin infections. Read more about this study
- Who is it for?
- Ages 0 months to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Eczema
- How many people
- 505 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2013to Dec 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 0 months to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Subjects will be recruited at Ann and Robert H. Lurie Children's Hospital Dermatology outpatient clinics. * 200 children with mild to severe AD, 100 aged-matched and sex-matched healthy (no evidence of atopy) controls, 100 aged-matched and sex-matched controls with an atopic condition (allergic rhinitis or asthma) but no history of atopic dermatitis * AD subjects between the ages of 0 months to 4 years of age will be asked to give buccal (cheek) swabs * 70 children with mild to severe atopic dermatitis, and 70 age- and sex-matched (but not site-matched) healthy controls (no evidence of atopy), will be enrolled to obtain skin biopsies. * 30 children with atopic dermatitis and 30 age/sex matched non-atopic controls for imaging evaluation. * Transepidermal water loss values will obtained in 300 healthy controls. * Cord blood will be collected from 30 healthy subjects at the time of delivery.
Who may be able to join
- Subjects may be of either sex and must be between the ages of 0 months and 17 years at the time of enrollment (Healthy controls, atopic controls, and AD patients)
- The skin sample and blood sample for healthy controls can have no systemic inflammatory disease or personal or familial history of atopy (hives, food allergy, allergic rhinitis or conjunctivitis, asthma)
- The atopic blood sample controls may have an atopic condition (allergic rhinitis or asthma) but no history of atopic dermatitis
- All controls for skin sampling may have no observable abnormality in the sampled skin and, to further assure the normality of the "normal" skin edges, must not have evidence of inflammation or epidermal change in the lesion to be surgically removed
- AD subjects must have mild to severe atopic dermatitis with either new onset disease within the last 6 months or with acute exacerbation of AD
- Subjects 17 years of age and older and parents/guardians of minors must sign the approved IRB assent and consent form(s) respectively prior to initiation of the study protocol
Who cannot join
- Subjects unable to give assent or parents unable to give consent due to cognitive delay or inability to understand the assent form either in writing or presented verbally (Healthy controls, atopic controls, and AD patients)
- All subjects whose main diagnosis is deemed unsafe by the study investigator for study participation. Examples include known hemophilia or other blood disorders, or skin infection at the site of blood draw or biopsy (Healthy controls, atopic controls, and AD patients)
- Control subjects with obvious xerosis (Healthy controls and atopic controls)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Northwestern University
Chicago, Illinois, 60611
Icahn School of Medicine at Mount Sinai
New York, New York, 10065
Northbrook Lurie Children's Outpatient Clinic
Northbrook, Illinois, 60062
About this study
Official title: Defining the Skin and Blood Biomarkers of Pediatric Atopic Dermatitis SUB-STUDY: Defining the Predictive Non-Invasive Biomarkers for Pediatric Atopic Dermatitis (Funded by Regeneron Pharmaceuticals, Inc.)
Atopic dermatitis (AD), also known as eczema, is the most common inflammatory skin disorder of children, affecting 10-20% of children and 1-2% of adults.
This skin disorder can be associated with unbearable itchiness and an increased susceptibility to skin infections. The cause of AD is currently poorly understood; therefore, there are no targeted treatment options at present. There have been recent studies in adults with AD that explain the cause and give us new routes to investigate treatment options, however no major studies in this arena have been done in children. We hope to evaluate the skin and blood biomarkers that are found in pediatric AD and compare them to adult AD.
Hypothesis: The immune system worsens the skin barrier issues that are common in atopic dermatitis. We believe there are similar immune and skin abnormalities in adult versus pediatric atopic dermatitis. Finally, blood levels of the activated molecules in atopic dermatitis can serve as surrogates for skin immune activation and will correlate with disease severity.
Read the detailed description
Objectives:
- To define the cellular and molecular biomarkers of atopic dermatitis in skin biopsies and blood samples from a pre-adolescent pediatric population and correlate it with disease severity.
- To measure the skin barrier in atopic dermatitis.
- To determine quality of life in atopic dermatitis through various questionnaires.
Objectives for the non-invasive biomarkers sub-study:
- Develop a panel of non-invasive biomarkers in tape strips and serum.
- Correlate mRNA expression from tape-striped skin with individual markers of severity (EASI, SCORAD, pruritus and TEWL).
- Correlate mRNA markers in blood with severity scores.
- Correlate serum protein markers with severity scores.
- Compare biomarkers based on patient age.
- Correlate the biomarker candidates from tape strips and blood with the "gold standard" set of biomarkers derived from age-matched skin biopsy samples
- Conditions
- Atopic Dermatitis, Eczema
- Keywords
- Atopic Dermatitis, Filaggrin, Biomarkers, Eczema
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Healthy subjects with no history of atopy (atopic dermatitis, asthma, or allergic rhinitis) from 0 months to 17 years of age that are age and sex matched to our atopic dermatitis subjects. | |
| Atopic Dermatitis | Children with atopic dermatitis from 0 months to 17 years of age. | |
| Control with Atopy history | Healthy subjects from 0 months to 17 years of age with history of asthma, food allergies, or allergic rhinitis, but no atopic dermatitis or with positive family history of atopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cellular infiltrates
We will examine skin and blood samples for various immune cells known to be involved in atopic dermatitis.
Measured: One year
Gene expression
We will examine skin and blood samples for various genes known to contribute to atopic dermatitis by analyzing RNA and cytokines.
Measured: One Year
Secondary outcomes (1)
Correlation of biomarkers to quality of life
We will analyze the blood and tissue biomarkers to determine whether they are comparable to quality of life and itch (pruritus) measures.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 505 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Rockefeller University, Icahn School of Medicine at Mount Sinai
- Responsible party
- Principal investigator, Amy Paller, Northwestern University
- Investigators
- Amy Paller, MD, Principal investigator, Northwestern UniversityEmma Guttman, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782703
- Sponsor's protocol ID
- 2013-15143
- Status last verified
- Apr 2026
- First submitted
- 31 Jan 2013
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Bieber T. Atopic dermatitis. Ann Dermatol. 2010 May;22(2):125-37. doi: 10.5021/ad.2010.22.2.125. Epub 2010 May 17.
PubMed 20548901Guttman-Yassky E, Nograles KE, Krueger JG. Contrasting pathogenesis of atopic dermatitis and psoriasis--part II: immune cell subsets and therapeutic concepts. J Allergy Clin Immunol. 2011 Jun;127(6):1420-32. doi: 10.1016/j.jaci.2011.01.054. Epub 2011 Mar 21.
PubMed 21419481Guttman-Yassky E, Nograles KE, Krueger JG. Contrasting pathogenesis of atopic dermatitis and psoriasis--part I: clinical and pathologic concepts. J Allergy Clin Immunol. 2011 May;127(5):1110-8. doi: 10.1016/j.jaci.2011.01.053. Epub 2011 Mar 8.
PubMed 21388665
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Skin and Blood Biomarkers of Pediatric Atopic Dermatitis SUB-STUDY: Defining the Predictive Non-Invasive Biomarkers for Pediatric Atopic Dermatitis (Funded by Regeneron Pharmaceuticals, Inc.)
- ClinicalTrials.gov ID
- NCT01782703
- Acronym / sponsor ID
- 2013-15143
- Conditions
- Atopic Dermatitis, Eczema
- Keywords
- Atopic Dermatitis, Filaggrin, Biomarkers, Eczema
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 505 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Rockefeller University, Icahn School of Medicine at Mount Sinai
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Feb 2013 (estimated)
- 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.
Atopic dermatitis (AD), also known as eczema, is the most common inflammatory skin disorder of children, affecting 10-20% of children and 1-2% of adults.
This skin disorder can be associated with unbearable itchiness and an increased susceptibility to skin infections. The cause of AD is currently poorly understood; therefore, there are no targeted treatment options at present. There have been recent studies in adults with AD that explain the cause and give us new routes to investigate treatment options, however no major studies in this arena have been done in children. We hope to evaluate the skin and blood biomarkers that are found in pediatric AD and compare them to adult AD.
Hypothesis: The immune system worsens the skin barrier issues that are common in atopic dermatitis. We believe there are similar immune and skin abnormalities in adult versus pediatric atopic dermatitis. Finally, blood levels of the activated molecules in atopic dermatitis can serve as surrogates for skin immune activation and will correlate with disease severity.
Detailed description
Objectives:
- To define the cellular and molecular biomarkers of atopic dermatitis in skin biopsies and blood samples from a pre-adolescent pediatric population and correlate it with disease severity.
- To measure the skin barrier in atopic dermatitis.
- To determine quality of life in atopic dermatitis through various questionnaires.
Objectives for the non-invasive biomarkers sub-study:
- Develop a panel of non-invasive biomarkers in tape strips and serum.
- Correlate mRNA expression from tape-striped skin with individual markers of severity (EASI, SCORAD, pruritus and TEWL).
- Correlate mRNA markers in blood with severity scores.
- Correlate serum protein markers with severity scores.
- Compare biomarkers based on patient age.
- Correlate the biomarker candidates from tape strips and blood with the "gold standard" set of biomarkers derived from age-matched skin biopsy samples
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Healthy subjects with no history of atopy (atopic dermatitis, asthma, or allergic rhinitis) from 0 months to 17 years of age that are age and sex matched to our atopic dermatitis subjects. |
| Atopic Dermatitis | – | –Children with atopic dermatitis from 0 months to 17 years of age. |
| Control with Atopy history | – | –Healthy subjects from 0 months to 17 years of age with history of asthma, food allergies, or allergic rhinitis, but no atopic dermatitis or with positive family history of atopy |
Who may qualify
- Ages
- 0 months to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Subjects will be recruited at Ann and Robert H. Lurie Children's Hospital Dermatology outpatient clinics. * 200 children with mild to severe AD, 100 aged-matched and sex-matched healthy (no evidence of atopy) controls, 100 aged-matched and sex-matched controls with an atopic condition (allergic rhinitis or asthma) but no history of atopic dermatitis * AD subjects between the ages of 0 months to 4 years of age will be asked to give buccal (cheek) swabs * 70 children with mild to severe atopic dermatitis, and 70 age- and sex-matched (but not site-matched) healthy controls (no evidence of atopy), will be enrolled to obtain skin biopsies. * 30 children with atopic dermatitis and 30 age/sex matched non-atopic controls for imaging evaluation. * Transepidermal water loss values will obtained in 300 healthy controls. * Cord blood will be collected from 30 healthy subjects at the time of delivery.
Key inclusion criteria (6 listed)
- Subjects may be of either sex and must be between the ages of 0 months and 17 years at the time of enrollment (Healthy controls, atopic controls, and AD patients)
- The skin sample and blood sample for healthy controls can have no systemic inflammatory disease or personal or familial history of atopy (hives, food allergy, allergic rhinitis or conjunctivitis, asthma)
- The atopic blood sample controls may have an atopic condition (allergic rhinitis or asthma) but no history of atopic dermatitis
- All controls for skin sampling may have no observable abnormality in the sampled skin and, to further assure the normality of the "normal" skin edges, must not have evidence of inflammation or epidermal change in the lesion to be surgically removed
- AD subjects must have mild to severe atopic dermatitis with either new onset disease within the last 6 months or with acute exacerbation of AD
Key exclusion criteria (3 listed)
- Subjects unable to give assent or parents unable to give consent due to cognitive delay or inability to understand the assent form either in writing or presented verbally (Healthy controls, atopic controls, and AD patients)
- All subjects whose main diagnosis is deemed unsafe by the study investigator for study participation. Examples include known hemophilia or other blood disorders, or skin infection at the site of blood draw or biopsy (Healthy controls, atopic controls, and AD patients)
- Control subjects with obvious xerosis (Healthy controls and atopic controls)
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
Cellular infiltrates
Time frame: One year
We will examine skin and blood samples for various immune cells known to be involved in atopic dermatitis.
Gene expression
Time frame: One Year
We will examine skin and blood samples for various genes known to contribute to atopic dermatitis by analyzing RNA and cytokines.
1 secondary outcome
Correlation of biomarkers to quality of life
Time frame: One year
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 27 Apr 2026.
- Background: PubMed 20548901Bieber T. Atopic dermatitis. Ann Dermatol. 2010 May;22(2):125-37. doi: 10.5021/ad.2010.22.2.125. Epub 2010 May 17.
- Background: PubMed 21419481Guttman-Yassky E, Nograles KE, Krueger JG. Contrasting pathogenesis of atopic dermatitis and psoriasis--part II: immune cell subsets and therapeutic concepts. J Allergy Clin Immunol. 2011 Jun;127(6):1420-32. doi: 10.1016/j.jaci.2011.01.054. Epub 2011 Mar 21.
- Background: PubMed 21388665Guttman-Yassky E, Nograles KE, Krueger JG. Contrasting pathogenesis of atopic dermatitis and psoriasis--part I: clinical and pathologic concepts. J Allergy Clin Immunol. 2011 May;127(5):1110-8. doi: 10.1016/j.jaci.2011.01.053. Epub 2011 Mar 8.
- Eczema: MedlinePlusLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Amy Paller, MD principal investigator
Northwestern University
Emma Guttman, MD principal investigator
Icahn School of Medicine at Mount Sinai
4 sites 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 and Eczema, run by Northwestern University at 4 sites 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 6 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cellular infiltrates (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01782703, which also lists 3 linked publications.
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 27 Apr 2026.