Skin Barrier Abnormalities and Oxidative Stress Response
NCT ID: NCT04606615
Last Updated: 2020-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
160 participants
OBSERVATIONAL
2020-10-16
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Adults: AD + FA
Adults: atopic dermatitis and food allergy to peanut
No interventions assigned to this group
Adults: AD - FA
Adults: atopic dermatitis and no food allergy
No interventions assigned to this group
Adults: NC
Adults: Normal Control
No interventions assigned to this group
Children: AD+ Peanut
Children: atopic dermatitis and food allergy to peanut
No interventions assigned to this group
Children: AD + Milk
atopic dermatitis and food allergy to milk
No interventions assigned to this group
Children: AD + Egg
atopic dermatitis and food allergy to egg
No interventions assigned to this group
Children: AD only
atopic dermatitis and no food allergy
No interventions assigned to this group
Children: NC
Normal Control
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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
1 Year
65 Years
ALL
Yes
Sponsors
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National Jewish Health
OTHER
Responsible Party
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Locations
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National Jewish Health
Denver, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ADRN3-CRC
Identifier Type: -
Identifier Source: org_study_id