Recruiting

Observational Study

Sponsor:

National Jewish Health

Code:

NCT04606615

Conditions

Atopic Dermatitis

Food Allergy

Eligibility Criteria

Sex: All

Age: 1 - 65

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Atopic Dermatitis

Food Allergy

Study ID

NCT04606615

Start date

Oct 16, 2020

Status verified date

Oct, 2020

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

160 participants

Anticipated

Interventions and Outcome Measures

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

Primary outcome measure

  • Transepidermal Water Loss (TEWL) [ Time Frame: Day 0 ]

Central Contacts and Locations

Central contacts

Locations

National Jewish Health

Recruiting

Denver, Colorado, United States, 80206

Contacts

Principal Investigator:

Elena Goleva, PhD

More Information

Sponsor

National Jewish Health

Last update posted

Oct 28, 2020

Last verified

Oct, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by National Jewish Health on 2020-10-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.