Skin Barrier Abnormalities and Oxidative Stress Response

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	1 Year - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. 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. 2. 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. 3. 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:

- 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)
Exclusion Criteria:
- 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04606615
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	National Jewish Health
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Atopic Dermatitis, Food Allergy

Arms & Interventions

Arms

: 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

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

National Jewish Health, Denver, Colorado

Status

Recruiting

Address

National Jewish Health

Denver, Colorado, 80206

Site Contact

Jessica Sussman

[email protected]

303-398-1717

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