Skin Characteristics of Parents of Food Allergic Pediatric Patients

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Conditions studied: Food Allergy in Children

In brief

The purpose of this study is to determine whether disruptions in the skin barrier of parents can contribute to the development of food allergies in their offspring. The study team will compare the superficial skin layers of mothers and fathers who do not have children with diagnosed food allergies to the skin layers of parents who do have children with diagnosed food allergy. The study will include a questionnaire, noninvasive superficial skin testing with skin tapping and transepidermal water loss measurements, and a blood draw.

Key facts

Study ID

NCT04198753

Run by

National Jewish Health

People needed

160

Starts

2020-01-23

Expected to finish

2020-10-06

Last updated by the study team

2020-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject has signed the informed consent form
• 18 years of age or older (inclusive) 3. One of the following Diagnostic Categories:
• Normal healthy controls with no personal or offspring history of food allergy or atopic dermatitis
• Mother or father without personal history of food allergy, but with a child diagnosed with peanut allergy. Peanut allergy is defined as fulfilling one of the following 3 criteria:
• i. Clinical history defined as one of the following occurring within 2 hours of exposure to peanut:
• Involvement of the skin-mucosal tissue (eg, generalized hives, itch-flush, swollen lips-tongue-uvula)
• Respiratory compromise (eg, dyspnea, wheeze-bronchospasm, stridor, reduced PEF, hypoxemia)
• Reduced BP or associated symptoms (eg, hypotonia [collapse], syncope, incontinence)
• Persistent gastrointestinal symptoms (eg, crampy abdominal pain, vomiting)
• ii. Positive skin prick testing > 8 mm
• iii. Positive specific IgE to peanut > 14.0 kUA/L

You may not qualify if…

• Has active flare of atopic dermatitis requiring use of bleach baths, topical corticosteroids, topical immunomodulatory agents, or topical antibiotics on the extremity being evaluated
• Has a skin disease other than AD that might compromise the stratum corneum barrier such as bullous disease, psoriasis, cutaneous T cell lymphoma, Darier's disease, HaileyHailey, or dermatitis herpetiformis
• Has a current systemic infection requiring use of systemic antibiotics, antiparasitics, antivirals, or antifungals
• Has a severe concomitant disease or immunosuppression such as lymphoma, HIV, or Wiskott-Aldrich syndrome
• Has a history of a severe reaction to latex, tape, or adhesives
• Has used any biologics within 5 half-lives or 16 weeks, whichever is longer
• Has received immunotherapy in the last 12 months
• Has used any investigational drugs within 5 half-lives or 8 weeks, whichever is longer
• Has used anticoagulants, anxiolytics, or antidepressants within 30 days
• Has used of systemic immunosuppressive drugs including oral steroids within 30 days
• Has received total body phototherapy (e.g., ultraviolet light B [UVB], psoralen plus ultraviolet light A [PUVA], tanning beds [>1 visit per week]) within 30 days
• Is pregnant or lactating (this will be self-verified by the patient)

Where it is running

• National Jewish Health — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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