Skin Characteristics of Parents of Food Allergic Pediatric Patients
NCT ID: NCT04198753
Last Updated: 2020-04-13
Study Results
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Basic Information
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SUSPENDED
160 participants
OBSERVATIONAL
2020-01-23
2020-10-06
Brief Summary
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Detailed Description
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The purpose of our study is to evaluate the skin characteristics and FLG gene mutation status of parents of known food allergic pediatric patients. The researchers hypothesize that parents of food allergic patients will have more significant disruptions in their skin barrier function than parents of children who do not suffer from food allergies.
In order to evaluate skin barrier disruptions in these subjects, two noninvasive methods will be performed including skin tape stripping, a total of 30 strips per subject, and transepidermal water loss measurements using a small device. Both methods are relatively painless and cause minimal risk to the participant. In order to evaluated FLG gene mutation status, blood draw will also be performed. Subjects will undergo a focused physical exam and also be requested to fill out a detailed questionnaire. The researchers will obtain additional offspring peanut allergy clinical characteristics from the medical records. All data collection will occur over 1-2 visits, averaging an anticipated 1 hour in total duration.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Parent of Peanut Allergic Child
The researchers will identify patients or study subjects aged 1-18 who have been diagnosed with peanut allergy based on skin prick testing, serologic testing, and/or history of reaction. They will then contact mothers or fathers of these patients/subjects who are 18 and older and enroll those who do not themselves have a history of food allergy, with a goal of 40 subjects per group.
The researchers will perform a very limited physical exam followed by skin tape stripping (30 strips) for lipid profile and protein expression, and transepidermal water loss (TEWL) measurements every 5 strips. They will obtain blood work to define FLG mutation and vitamin D status. Questionnaires on their background, other concurrent atopic and nonatopic diseases, and exposures, will also be collected.
Skin tape stripping
Adhesive skin sampling discs will be firmly pressed against the skin in a hairless location (not the face) followed by lifting it free of the skin. Tape stripping will be collected from non-lesional skin up to 30 times. These discs will then be used to evaluate proteins and lipids. With every 5 tape strips collected, transepidermal water loss measurements will be performed.
Skin barrier assessment
A small device will be used to measure transepidermal water loss (TEWL), which is the quantity of water that passes from inside the body through the skin to the surrounding atmosphere via diffusion and evaporation process. The device, a probe, is simply placed against the skin surface making superficial contact and kept there for a few seconds until the measurement terminates. This will be performed at baseline and after every 5 tape strips.
Blood draw
Subjects will undergo genetic testing of FLG mutation status (5mL of whole blood in lavender top tube) and vitamin D level (2mL of whole blood in red top tube) via blood draw.
Parent of Non-atopic Child
To establish normal controls, the researchers will enroll parents age 18 or older with no history of food allergy or eczema in themselves or their offspring.
The researchers will perform a very limited physical exam followed by skin tape stripping (30 strips) for lipid profile and protein expression, and transepidermal water loss (TEWL) measurements every 5 strips. They will obtain blood work to define FLG mutation and vitamin D status. Questionnaires on their background, other concurrent atopic and nonatopic diseases, and exposures, will also be collected.
Skin tape stripping
Adhesive skin sampling discs will be firmly pressed against the skin in a hairless location (not the face) followed by lifting it free of the skin. Tape stripping will be collected from non-lesional skin up to 30 times. These discs will then be used to evaluate proteins and lipids. With every 5 tape strips collected, transepidermal water loss measurements will be performed.
Skin barrier assessment
A small device will be used to measure transepidermal water loss (TEWL), which is the quantity of water that passes from inside the body through the skin to the surrounding atmosphere via diffusion and evaporation process. The device, a probe, is simply placed against the skin surface making superficial contact and kept there for a few seconds until the measurement terminates. This will be performed at baseline and after every 5 tape strips.
Blood draw
Subjects will undergo genetic testing of FLG mutation status (5mL of whole blood in lavender top tube) and vitamin D level (2mL of whole blood in red top tube) via blood draw.
Interventions
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Skin tape stripping
Adhesive skin sampling discs will be firmly pressed against the skin in a hairless location (not the face) followed by lifting it free of the skin. Tape stripping will be collected from non-lesional skin up to 30 times. These discs will then be used to evaluate proteins and lipids. With every 5 tape strips collected, transepidermal water loss measurements will be performed.
Skin barrier assessment
A small device will be used to measure transepidermal water loss (TEWL), which is the quantity of water that passes from inside the body through the skin to the surrounding atmosphere via diffusion and evaporation process. The device, a probe, is simply placed against the skin surface making superficial contact and kept there for a few seconds until the measurement terminates. This will be performed at baseline and after every 5 tape strips.
Blood draw
Subjects will undergo genetic testing of FLG mutation status (5mL of whole blood in lavender top tube) and vitamin D level (2mL of whole blood in red top tube) via blood draw.
Eligibility Criteria
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Inclusion Criteria
2. 18 years of age or older (inclusive) 3. One of the following Diagnostic Categories:
1. Normal healthy controls with no personal or offspring history of food allergy or atopic dermatitis
2. 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:
1. Involvement of the skin-mucosal tissue (eg, generalized hives, itch-flush, swollen lips-tongue-uvula)
2. Respiratory compromise (eg, dyspnea, wheeze-bronchospasm, stridor, reduced PEF, hypoxemia)
3. Reduced BP or associated symptoms (eg, hypotonia \[collapse\], syncope, incontinence)
4. 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
Exclusion Criteria
2. 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
3. Has a current systemic infection requiring use of systemic antibiotics, antiparasitics, antivirals, or antifungals
4. Has a severe concomitant disease or immunosuppression such as lymphoma, HIV, or Wiskott-Aldrich syndrome
5. Has a history of a severe reaction to latex, tape, or adhesives
6. Has used any biologics within 5 half-lives or 16 weeks, whichever is longer
7. Has received immunotherapy in the last 12 months
8. Has used any investigational drugs within 5 half-lives or 8 weeks, whichever is longer
9. Has used anticoagulants, anxiolytics, or antidepressants within 30 days
10. Has used of systemic immunosuppressive drugs including oral steroids within 30 days
11. 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
12. Is pregnant or lactating (this will be self-verified by the patient)
18 Years
ALL
Yes
Sponsors
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National Jewish Health
OTHER
Responsible Party
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Locations
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National Jewish Health
Denver, Colorado, United States
Countries
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References
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Lack G. Update on risk factors for food allergy. J Allergy Clin Immunol. 2012 May;129(5):1187-97. doi: 10.1016/j.jaci.2012.02.036. Epub 2012 Mar 30.
Esparza-Gordillo J, Matanovic A, Marenholz I, Bauerfeind A, Rohde K, Nemat K, Lee-Kirsch MA, Nordenskjold M, Winge MC, Keil T, Kruger R, Lau S, Beyer K, Kalb B, Niggemann B, Hubner N, Cordell HJ, Bradley M, Lee YA. Maternal filaggrin mutations increase the risk of atopic dermatitis in children: an effect independent of mutation inheritance. PLoS Genet. 2015 Mar 10;11(3):e1005076. doi: 10.1371/journal.pgen.1005076. eCollection 2015 Mar.
Broccardo CJ, Mahaffey SB, Strand M, Reisdorph NA, Leung DY. Peeling off the layers: skin taping and a novel proteomics approach to study atopic dermatitis. J Allergy Clin Immunol. 2009 Nov;124(5):1113-5.e1-11. doi: 10.1016/j.jaci.2009.07.057. Epub 2009 Sep 12. No abstract available.
Kelleher M, Dunn-Galvin A, Hourihane JO, Murray D, Campbell LE, McLean WHI, Irvine AD. Skin barrier dysfunction measured by transepidermal water loss at 2 days and 2 months predates and predicts atopic dermatitis at 1 year. J Allergy Clin Immunol. 2015 Apr;135(4):930-935.e1. doi: 10.1016/j.jaci.2014.12.013. Epub 2015 Jan 22.
Other Identifiers
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HS-3257
Identifier Type: -
Identifier Source: org_study_id
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