Atopic DermatitisNCT04606615
Skin Barrier Abnormalities and Oxidative Stress Response
An observational study of Atopic Dermatitis and Food Allergy, run by National Jewish Health at 1 site in United States.
Trial summary
This is a prospective, single-site controlled observational study designed to comprehensively determine whether children and adults with atopic dermatitis (AD) and food allergy (FA) have skin abnormalities which distinguish them from children with AD without FA, and non-atopic (NA) controls. Read more about this study
- Who is it for?
- Ages 1 year to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Food Allergy
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 year to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population will children and adults. We will include children aged 1-17 years. We will enroll up to 20 AD children with food allergy to peanut, up to 20 AD children with food allergy to milk and no peanut allergy, up to 20 AD children with food allergy to eggs and no peanut allergy, up to 20 AD children without a history of food allergy, and up to 20 NA children. In addition, 18-65 old adults will be enrolled, including up to 20 adults with food allergy to peanut, up to 20 adults with AD without history of food allergy and 20 healthy controls.
Who may be able to join
- Male or female, 1 to 17 years of age inclusive at Screening for the pediatric group, 18-65 years of age for the adult group
- For all pediatric participants parent guardian must be able to understand and provide informed consent and participant provide assent as applicable per Institutional Review Board (IRB) guidelines and regulations
- Children: active AD and food allergy to peanut OR active AD and food allergy to milk OR active AD and food allergy to eggs. Adults: active AD and food allergy to peanut. Participant must meet all of the following criteria:
- Self-report or documentation of a positive oral food challenge to peanut OR egg OR milk or self-report of an allergic reaction to peanut OR egg OR milk within 2 hours of ingestion
- Skin prick test wheal≥8mm for peanut, milk or egg OR
- Active AD and no food allergy. Participant must meet all of the following criteria:
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- No personal history or current manifestations of food allergy (based on no self-report of a positive oral food challenge, positive skin test, positive blood test, or allergic reactions)
- Negative skin prick test (wheal<3mm) to peanut, milk, egg, wheat, soy, shellfish mix, treenuts, and sesame seed OR
- NA. Participant must meet all of the following criteria:
- No personal history or current manifestations of AD, asthma, or allergic rhinitis (based on self-report)
- No personal history or current manifestations of food allergy (based on no self-report of a positive oral food challenge, positive skin test, positive blood test, or allergic reactions)
- Negative skin pricktest (wheal<3mm) to peanut, milk, egg, wheat, soy, shellfish mix, treenuts, and sesame seed
- Negative skin prick test(wheal<3mm) to environmental allergens (cat, dog, dustmite, cockroach, and local trees/grasses/weeds/molds)
Who cannot join
- 1. Inability or unwillingness of a parent guardian (for pediatric participants) to give written informed consent, or participant to give assent, if applicable, or to comply with study protocol 2. Who have any skin disease other than AD that might compromise the stratum corneum barrier (e.g., bullous diseases, psoriasis, cutaneous T cell lymphoma [also called Mycosis Fungoides or Sezary syndrome], dermatitis herpetiformis, Hailey-Hailey, or Darier's disease).
- 3. Pregnant or lactating females 4. Known or suspected immunosuppression 5. Severe concomitant illness(es) 6. History of serious life-threatening reaction to latex, tape, or adhesives 7. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study 8. Use of biologics within 5 half-lives (if known) or 16 weeks of the Screening Visit 9. Use of an investigational drug within 5 half-lives (if known) or 8 weeks of the Screening Visit 10. Has received immunotherapy within 12 months of the Screening Visit
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
National Jewish Health
Denver, Colorado, 80206
Jessica Sussman, 303-398-1717, sussmanj@njhealth.org
Elena Goleva, golevae@njhealth.org
About this study
Official title: Skin Barrier Abnormalities and Oxidative Stress Response in the Skin of Atopic Dermatitis Patients With Food Allergy
This is a prospective, single-site controlled observational study designed to comprehensively determine whether children and adults with atopic dermatitis (AD) and food allergy (FA) have skin abnormalities which distinguish them from children with AD without FA, and non-atopic (NA) controls.
- Conditions
- Atopic Dermatitis, Food Allergy
- Medical subject headings
- Dermatitis, Atopic, Food Hypersensitivity
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 |
|---|---|---|
| Adults: AD + FA | Adults: atopic dermatitis and food allergy to peanut | |
| Adults: AD - FA | Adults: atopic dermatitis and no food allergy | |
| Adults: NC | Adults: Normal Control | |
| Children: AD+ Peanut | Children: atopic dermatitis and food allergy to peanut | |
| Children: AD + Milk | atopic dermatitis and food allergy to milk | |
| Children: AD + Egg | atopic dermatitis and food allergy to egg | |
| Children: AD only | atopic dermatitis and no food allergy | |
| Children: NC | Normal Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transepidermal Water Loss (TEWL)
area under the TEWL curve (AUC) from four non-lesional skin sites assessed. TEWL will be assessed on non-lesional skin prior to tape stripping and repeated after 5, 10, 15, and 20 tape strips.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start16 Oct 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (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.
- 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
- Cross-sectional
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606615
- Sponsor's protocol ID
- ADRN3-CRC
- Status last verified
- Oct 2020
- First submitted
- 16 Oct 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Barrier Abnormalities and Oxidative Stress Response in the Skin of Atopic Dermatitis Patients With Food Allergy
- ClinicalTrials.gov ID
- NCT04606615
- Acronym / sponsor ID
- ADRN3-CRC
- Conditions
- Atopic Dermatitis, Food Allergy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 28 Oct 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 is a prospective, single-site controlled observational study designed to comprehensively determine whether children and adults with atopic dermatitis (AD) and food allergy (FA) have skin abnormalities which distinguish them from children with AD without FA, and non-atopic (NA) controls.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Adults: AD + FA | – | –Adults: atopic dermatitis and food allergy to peanut |
| Adults: AD - FA | – | –Adults: atopic dermatitis and no food allergy |
| Adults: NC | – | –Adults: Normal Control |
| Children: AD+ Peanut | – | –Children: atopic dermatitis and food allergy to peanut |
| Children: AD + Milk | – | –atopic dermatitis and food allergy to milk |
| Children: AD + Egg | – | –atopic dermatitis and food allergy to egg |
| Children: AD only | – | –atopic dermatitis and no food allergy |
| Children: NC | – | –Normal Control |
Who may qualify
- Ages
- 1 year to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will children and adults. We will include children aged 1-17 years. We will enroll up to 20 AD children with food allergy to peanut, up to 20 AD children with food allergy to milk and no peanut allergy, up to 20 AD children with food allergy to eggs and no peanut allergy, up to 20 AD children without a history of food allergy, and up to 20 NA children. In addition, 18-65 old adults will be enrolled, including up to 20 adults with food allergy to peanut, up to 20 adults with AD without history of food allergy and 20 healthy controls.
Key inclusion criteria (13 listed)
- Male or female, 1 to 17 years of age inclusive at Screening for the pediatric group, 18-65 years of age for the adult group
- For all pediatric participants parent guardian must be able to understand and provide informed consent and participant provide assent as applicable per Institutional Review Board (IRB) guidelines and regulations
- Children: active AD and food allergy to peanut OR active AD and food allergy to milk OR active AD and food allergy to eggs. Adults: active AD and food allergy to peanut. Participant must meet all of the following criteria:
- No personal history or current manifestations of AD, asthma, or allergic rhinitis (based on self-report)
- No personal history or current manifestations of food allergy (based on no self-report of a positive oral food challenge, positive skin test, positive blood test, or allergic reactions)
Key exclusion criteria (2 listed)
- 1. Inability or unwillingness of a parent guardian (for pediatric participants) to give written informed consent, or participant to give assent, if applicable, or to comply with study protocol 2. Who have any skin disease other than AD that might compromise the stratum corneum barrier (e.g., bullous diseases, psoriasis, cutaneous T cell lymphoma [also called Mycosis Fungoides or Sezary syndrome], dermatitis herpetiformis, Hailey-Hailey, or Darier's disease).
- 3. Pregnant or lactating females 4. Known or suspected immunosuppression 5. Severe concomitant illness(es) 6. History of serious life-threatening reaction to latex, tape, or adhesives 7. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study 8. Use of biologics within 5 half-lives (if known) or 16 weeks of the Screening Visit 9. Use of an investigational drug within 5 half-lives (if known) or 8 weeks of the Screening Visit 10. Has received immunotherapy within 12 months of the Screening Visit
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
Transepidermal Water Loss (TEWL)
Time frame: Day 0
area under the TEWL curve (AUC) from four non-lesional skin sites assessed. TEWL will be assessed on non-lesional skin prior to tape stripping and repeated after 5, 10, 15, and 20 tape strips.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Individual participant dataSharing planned: No
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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.
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 and Food Allergy, run by National Jewish Health 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 13 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Goleva, PhD (303.398.1637, golevae@njhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transepidermal Water Loss (TEWL) (time frame: Day 0). 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 28 Oct 2020.