Atopic Dermatitis (AD) and Food Allergy
Skin Barrier in Childhood Atopic Dermatitis With and Without Food Allergy (ADRN-10)
Study Overview
Status
Status
Conditions
Conditions
Detailed Description
Atopic Dermatitis (AD) is a chronic inflammatory skin disorder in which the skin becomes extremely itchy and is susceptible to recurrent skin infections. AD is thought to occur from a combination of immunological, genetic, and environmental factors.
Those with atopic dermatitis (AD) often have food allergy and Staphylococcus aureus (S. aureus) colonization of the skin. There is evidence suggesting that skin barrier dysfunction, measurable as increased transepidermal water loss (TEWL), is a predisposing factor to food sensitization and food allergy from epicutaneous penetration of environmental food allergens. Furthermore, the investigators for this study have identified that AD children with food allergy, especially peanut allergy, are colonized with Staphylococcus aureus. However, only half (50%) of children with AD have food allergy or S. aureus colonization, suggesting there are other factors accounting for food allergy. There have been no previous studies of TEWL or, microbial or molecular profiling of the skin in those with AD prone to food allergy versus AD without food allergy.
Study Type
Study Type
Enrollment (Actual)
Enrollment
Contacts and Locations
Study Locations
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Colorado
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Denver, Colorado, United States, 80206
- National Jewish Health: Division of Pediatric Allergy and Clinical Immunology
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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
- Negative skin prick test (wheal < 3 mm) to environmental allergens (cat, dog, dust mite, cockroach, and local trees/grasses/weeds/molds).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
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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. |
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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. |
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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. |
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Transepidermal Water Loss (TEWL) Area Under the Curve
Time Frame: Visit 1 (Day 1)
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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.
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Visit 1 (Day 1)
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Basal Transepidermal Water Loss (TEWL)
Time Frame: Visit 1 (Day 1)
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TEWL is a noninvasive in vivo measurement of water loss across the stratum corneum that is used to characterize skin water barrier function.
Basal TEWL =baseline measure.
Comparison between groups (e.g., atopic dermatitis [AD] children with food allergy, AD children without food allergy and Non-Atopic children) of basal TEWL on non-lesional and lesional skin will be evaluated.
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Visit 1 (Day 1)
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Transepidermal Water Loss (TEWL) Measured After 20 Tape Strips
Time Frame: Visit 1 (Day 1)
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TEWL will be assessed on non-lesional skin after 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.
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Visit 1 (Day 1)
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Lipid Profiles
Time Frame: Visit 1 (Day 1)
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Lipids, which play a role in the skin barrier, will be extracted from the skin tape strips and measured using mass spectrometry methodology.
Sampling will involve the upper extremities.
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.
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Visit 1 (Day 1)
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Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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EXPLORATORY: Protein Expression Profiles
Time Frame: Visit 1 (Day 1)
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Differences between groups (e.g., atopic dermatitis [AD] children with food allergy, AD children without food allergy and Non-atopic children) in protein expression (e.g., proteomic profiles) in samples extracted from skin tape strips will be evaluated.
Sampling will involve the upper extremities.
Skin tape strip method allows characterization of components of the epidermis, dermis, and immune cells present in the skin.
The protein expression profiles will be measured by mass spectrometry of skin tape strips.
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Visit 1 (Day 1)
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EXPLORATORY: Gene Expression Profiles
Time Frame: Visit 1 (Day 1)
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Differential expression of gene transcripts between groups (e.g., atopic dermatitis [AD] children with food allergy, AD children without food allergy and Non-atopic children) will be evaluated from skin tape strips.
Skin tape strip method allows characterization of components of the epidermis, dermis, and immune cells present in the skin.
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Visit 1 (Day 1)
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EXPLORATORY: Microbial Carriage
Time Frame: Visit 1 (Day 1)
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Microbial carriage as assessed by the presence of microbial sequencing reads.
Skin swab samples will include defined non-lesional and lesional areas of the upper and lower extremities.
Comparison of the skin microbiome composition between groups (e.g., atopic dermatitis [AD] children with food allergy, AD children without food allergy and Non-atopic children) using metagenomics.
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Visit 1 (Day 1)
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EXPLORATORY:Carriage of Transcriptionally Active Microbial Species
Time Frame: Visit 1 (Day 1)
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A metatranscriptomics approach will allow for evaluation of the transcriptional response of active microbiome members of the skin.
Skin swab samples will include defined non-lesional and lesional areas of the upper and lower extremities.
The comparison using this methodology is between groups (e.g., atopic dermatitis [AD] children with food allergy, AD children without food allergy and Non-atopic children).
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Visit 1 (Day 1)
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EXPLORATORY: Frequency of Commensal Antimicrobial Coagulase-Negative Staphylococcus (CoNS)
Time Frame: Visit 1 (Day 1)
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Skin surface bacteria will be collected and typed. Skin swab samples will include defined non-lesional and lesional areas of the upper and lower extremities. Comparison between groups (e.g., atopic dermatitis [AD] children with food allergy, AD children without food allergy and Non-atopic children) for anti- Staphylococcus aureus (S. aureus) activity of CoNS cultured from skin will be evaluated. This is a functional assessment of antimicrobial activity. |
Visit 1 (Day 1)
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Donald Leung, M.D., Ph.D., National Jewish Health: Division of Pediatric Allergy and Clinical Immunology
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Study Start
Primary Completion (ACTUAL)
Primary Completion
Study Completion (ACTUAL)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ACTUAL)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- DAIT ADRN-10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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