Atopic Dermatitis (AD) and Food Allergy

NCT03168113 | Completed

• 1 other identifier: DAIT ADRN-10
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single center, clinical mechanistic pilot clinical research study. Participants will not receive any investigational agent. The investigators will examine whether children with atopic dermatitis (AD) and food allergy have a different skin barrier, microbiome, epidermal transcriptome, and epidermal lipid composition than children with AD and no food allergy and non-atopic (NA) children. Participation involves a single study visit.

Conditions

Atopic Dermatitis (AD); Non-atopic Healthy Controls

Keywords

skin barrier function; microbiome; transepidermal water loss (TEWL); epidermal transcriptome; epidermal lipid composition

Outcome Measures

Primary Outcomes (1)

• The Transepidermal Water Loss (TEWL) Area Under the Curve

  TEWL will be assessed on non-lesional skin prior to tape stripping (Basal) and repeated after 5, 10, 15, and 20 tape strips. TEWL is a noninvasive in vivo measurement of water loss across the stratum corneum. Skin tape strip method allows characterization of components of the epidermis, dermis, and immune cells present in the skin. Comparison between groups (e.g., atopic dermatitis \[AD\] children with food allergy, AD children without food allergy and Non-atopic children) will be evaluated.

  Visit 1 (Day 1)

Secondary Outcomes (3)

• Basal Transepidermal Water Loss (TEWL)

  Visit 1 (Day 1)

• Transepidermal Water Loss (TEWL) Measured After 20 Tape Strips

  Visit 1 (Day 1)

• Lipid Profiles

  Visit 1 (Day 1)

Other Outcomes (5)

• EXPLORATORY: Protein Expression Profiles

  Visit 1 (Day 1)

• EXPLORATORY: Gene Expression Profiles

  Visit 1 (Day 1)

• EXPLORATORY: Microbial Carriage

  Visit 1 (Day 1)

Study Arms (3)

AD and Peanut Food Allergy

Participants with active Atopic Dermatitis (AD) and food allergy to peanut.\* Twenty participants ages 4 to 17 years of age will be enrolled in this group. \*Peanut skin prick test wheal ≥ 8 mm.

AD and No Food Allergy

Participants with active Atopic Dermatitis (AD) and no food allergy.\* Twenty participants ages 4 to 17 years of age will be enrolled in this group. \*Negative skin prick test (wheal \< 3 mm) to peanut, milk, egg, wheat, soy, shellfish mix, tree nuts, and sesame seed.

Non-Atopic Health Control

Participants that are non-atopic, healthy controls\*. Twenty participants ages 4 to 17 years of age will be enrolled in this group. \*Negative for Atopic Dermatitis (AD), asthma, or allergic rhinitis; negative for food allergy; and negative by skin prick test to peanut, milk, egg, wheat, soy, shellfish mix, tree nuts, and sesame seed, and negative to environmental allergens - cat, dog, dust mite, cockroach, and local trees/grasses/weeds/molds.

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children ages 4-17 years, inclusive. Enrollment will include 20 AD children with food allergy to peanut, 20 AD children without a history of food allergy, and up to 20 NA children. The study requires that AD participants with peanut allergy meet the 95% positive predictive value for skin prick test (≥ 8 mm wheal) for peanut allergy. Food allergic AD participants will be allowed to have other food allergies in addition to peanut. A subset of children with AD whose disease is too severe to stop prohibited medications as defined in the protocol will be excluded. NA children will serve as a healthy control group for the AD study participants. Enrollment is to children since AD and food allergies are more prevalent among children, and adult onset AD and/or food allergy is a different phenotype.

You may qualify if:

• Participants fulfilling all of the following criteria are eligible for enrollment-
• 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;
• For Eligibility to One of the Two Active Atopic Dermatitis (AD) Groups:
• Active Atopic Dermatitis (AD) without a history or current manifestations of eczema herpeticum (EH), as diagnosed using the Atopic Dermatitis Registry
• Network (ADRN) Standard Diagnostic Criteria 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 self-report of an allergic reaction to peanut within 2 hours of ingestion
• Peanut skin prick test wheal ≥ 8 mm. OR -Active AD without a history or current manifestations of EH, as diagnosed using ADRN Standard Diagnostic Criteria 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 \< 3 mm) to peanut, milk, egg, wheat, soy, shellfish mix, tree nuts, and sesame seed.
• For Non-atopic (NA) Group Eligibility:
• 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 prick test (wheal \< 3 mm) to peanut, milk, egg, wheat, soy, shellfish mix, tree nuts, and sesame seed; and

You may not qualify if:

• Inability or unwillingness of a parent/guardian to give written informed consent, or participant to give assent, if applicable, or to comply with study protocol;
• Subjects with 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);
• Pregnant or lactating females;
• Known or suspected immunosuppression;
• Severe concomitant illness(es);
• History of serious life-threatening reaction to latex, tape, or adhesives;
• 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;
• Use of biologics within 5 half-lives (if known) or 16 weeks of the Screening Visit;
• Use of an investigational drug within 5 half-lives (if known) or 8 weeks of the Screening Visit; or
• Has received immunotherapy within 12 months of the Screening Visit.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Atopic Dermatitis Research Network: collaborator

Study Sites (1)

National Jewish Health: Division of Pediatric Allergy and Clinical Immunology

Denver, Colorado, 80206, United States

Location

Related Publications (1)

• Lyubchenko T, Collins HK, Goleva E, Leung DYM. Skin tape sampling technique identifies proinflammatory cytokines in atopic dermatitis skin. Ann Allergy Asthma Immunol. 2021 Jan;126(1):46-53.e2. doi: 10.1016/j.anai.2020.08.397. Epub 2020 Sep 5.

  PMID: 32896640 DERIVED

Related Links

• National Institute of Allergy and Infectious Diseases (NIAID) Website

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Plasma, DNA, Skin tape strip samples and any derivatives, Skin swabs and any derivatives, Stool samples and any derivatives

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Donald Leung, M.D., Ph.D.

  National Jewish Health: Division of Pediatric Allergy and Clinical Immunology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 30, 2017
• Study Start: June 12, 2017
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: February 28, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)