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Skin Barrier Abnormalities and Oxidative Stress Response

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ClinicalTrials.gov Identifier: NCT04606615
Recruitment Status : Recruiting
First Posted : October 28, 2020
Last Update Posted : October 28, 2020
Sponsor:
Information provided by (Responsible Party):
National Jewish Health

Study Description
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Brief 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.

Condition or disease
Atopic Dermatitis Food Allergy

Study Design
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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Skin Barrier Abnormalities and Oxidative Stress Response in the Skin of Atopic Dermatitis Patients With Food Allergy
Actual Study Start Date : October 16, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04606615


Contacts
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Contact: Elena Goleva, PhD 303.398.1637 golevae@njhealth.org

Locations
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United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Jessica Sussman    303-398-1717    sussmanj@njhealth.org   
Contact: Elena Goleva       golevae@njhealth.org   
Principal Investigator: Elena Goleva, PhD         
Sponsors and Collaborators
National Jewish Health
More Information
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Responsible Party: National Jewish Health
ClinicalTrials.gov Identifier: NCT04606615    
Other Study ID Numbers: ADRN3-CRC
First Posted: October 28, 2020    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Hypersensitivity
Food Hypersensitivity
Skin Diseases
 Immune System Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate