Skin Barrier Abnormalities and Oxidative Stress Response

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.

Study Overview

• Status: Unknown
• Conditions: Atopic Dermatitis; Food Allergy

• Study Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80206
      • Recruiting
      • National Jewish Health
      • Contact: Jessica Sussman; Phone Number: 303-398-1717; Email: sussmanj@njhealth.org
      • Contact: Elena Goleva; Email: golevae@njhealth.org
      • Principal Investigator: Elena Goleva, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

8

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0

Collaborators and Investigators

• Sponsor: National Jewish Health

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: October 16, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 28, 2020

Study Record Updates

• Last Update Posted (Actual): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 22, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Skin Diseases, Eczematous; Hypersensitivity; Dermatitis; Eczema; Dermatitis, Atopic; Food Hypersensitivity
• Other Study ID Numbers: ADRN3-CRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No