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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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Inclusion Criteria:
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
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
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:
NA. Participant must meet all of the following criteria:
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
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elena Goleva, PhD | Contact | 303.398.1637 | golevae@njhealth.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health | Recruiting | Denver | Colorado | 80206 | United States |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D005512 | Food Hypersensitivity |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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Normal Control
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |