Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy

NCT03089476 | Withdrawn

• 1 other identifier: 3083
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

It is hypothesized that food allergy is preceded by atopic dermatitis (AD), due to a disruption of skin barrier which can predispose one to food sensitization through the skin. The central hypothesis is that increased transepidermal water loss (TEWL) assessment and skin tape strip analysis (STS) of lipid and filaggrin breakdown products will be predictive markers for the development of AD. Additionally, the associated changes in TEWL and STS will further improve the identification of infants at risk of early food sensitization, compared to family history alone.

Conditions

Atopic Dermatitis; Eczema; Food Allergy

Keywords

Prevention; Predictors

Outcome Measures

Primary Outcomes (1)

• Serial Transepidermal Water Loss (TEWL)

  Skin Barrier Assessment measured through serial transepidermal water loss (TEWL) in grams of water/meters-squared/hour

  12 months

Secondary Outcomes (2)

• Skin Tape Stripping (STS) and Filaggrin(FLG) breakdown products

  Up to 12 months

• Skin prick testing to milk, egg, and peanut

  12 months

Study Arms (2)

High Risk Atopic Infants

OTHER

Infants, who are at high risk of atopy, which will be determined by a validated questionnaire, will be enrolled. Infants will undergo skin tape stripping (STS), transepidermal water loss assessment (TEWL), bacterial swabs, and parental questionnaires at each visit (3 visits total). At the latter 2 visits, infants will also undergo skin prick testing to evaluate for food sensitization.

Other: Evaluating atopy in infants

Atopic Adults

OTHER

Parents of infants enrolled in the study will undergo skin tape stripping (STS), transepidermal water loss assessment (TEWL), and complete questionnaires at the first visit.

Other: Evaluating TEWL and STS in adults

Interventions

Evaluating atopy in infants OTHER

This study does not have an intervention. There is the evaluation of the predictive value of TEWL and STS in atopic infants at risk of developing eczema and TEWL and STS in parents of infants.

Also known as: Atopy, Allergies

High Risk Atopic Infants

Evaluating TEWL and STS in adults OTHER

This study does not have an intervention. There is the evaluation of the predictive value of TEWL and STS in atopic infants at risk of developing eczema and TEWL and STS in parents of infants.

Also known as: Atopy, Transepidermal water loss, Skin tape stripping

Atopic Adults

Eligibility Criteria

• Age: 34 Weeks - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women with physician confirmed pregnancy at a gestational age of ≥ 34 weeks. Infants at high risk for atopy will have one or both parents affected by an allergic disease. Infants at low risk for atopy will have no parent or sibling affected by allergic disease. Biologic parent(s) of infants at high risk of atopy will also be enrolled in the study.

You may not qualify if:

• Pregnancy loss or delivery prior to a gestational age of ≥ 34 weeks, a history of substance or alcohol abuse, psychiatric and developmental co-morbidities that would render a subject unable to provide informed consent or perform study-related procedures, AIDS and HIV infection, or a fetus with chromosomal or congenital abnormalities.

Sponsors & Collaborators

• National Jewish Health: lead

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

Location

Related Publications (14)

• Walker L, Downe S, Gomez L. Skin care in the well term newborn: two systematic reviews. Birth. 2005 Sep;32(3):224-8. doi: 10.1111/j.0730-7659.2005.00374.x.

  PMID: 16128978 BACKGROUND

• Blume-Peytavi U, Hauser M, Stamatas GN, Pathirana D, Garcia Bartels N. Skin care practices for newborns and infants: review of the clinical evidence for best practices. Pediatr Dermatol. 2012 Jan-Feb;29(1):1-14. doi: 10.1111/j.1525-1470.2011.01594.x. Epub 2011 Oct 20.

  PMID: 22011065 BACKGROUND

• Elias PM. Lipid abnormalities and lipid-based repair strategies in atopic dermatitis. Biochim Biophys Acta. 2014 Mar;1841(3):323-30. doi: 10.1016/j.bbalip.2013.10.001. Epub 2013 Oct 12.

  PMID: 24128970 BACKGROUND

• Mao-Qiang M, Brown BE, Wu-Pong S, Feingold KR, Elias PM. Exogenous nonphysiologic vs physiologic lipids. Divergent mechanisms for correction of permeability barrier dysfunction. Arch Dermatol. 1995 Jul;131(7):809-16. doi: 10.1001/archderm.131.7.809.

  PMID: 7611797 BACKGROUND

• Feingold KR, Elias PM. Role of lipids in the formation and maintenance of the cutaneous permeability barrier. Biochim Biophys Acta. 2014 Mar;1841(3):280-94. doi: 10.1016/j.bbalip.2013.11.007. Epub 2013 Nov 18.

  PMID: 24262790 BACKGROUND

• Simpson EL, Chalmers JR, Hanifin JM, Thomas KS, Cork MJ, McLean WH, Brown SJ, Chen Z, Chen Y, Williams HC. Emollient enhancement of the skin barrier from birth offers effective atopic dermatitis prevention. J Allergy Clin Immunol. 2014 Oct;134(4):818-23. doi: 10.1016/j.jaci.2014.08.005.

  PMID: 25282563 BACKGROUND

• Horimukai K, Morita K, Narita M, Kondo M, Kitazawa H, Nozaki M, Shigematsu Y, Yoshida K, Niizeki H, Motomura K, Sago H, Takimoto T, Inoue E, Kamemura N, Kido H, Hisatsune J, Sugai M, Murota H, Katayama I, Sasaki T, Amagai M, Morita H, Matsuda A, Matsumoto K, Saito H, Ohya Y. Application of moisturizer to neonates prevents development of atopic dermatitis. J Allergy Clin Immunol. 2014 Oct;134(4):824-830.e6. doi: 10.1016/j.jaci.2014.07.060.

  PMID: 25282564 BACKGROUND

• Kong HH, Oh J, Deming C, Conlan S, Grice EA, Beatson MA, Nomicos E, Polley EC, Komarow HD; NISC Comparative Sequence Program; Murray PR, Turner ML, Segre JA. Temporal shifts in the skin microbiome associated with disease flares and treatment in children with atopic dermatitis. Genome Res. 2012 May;22(5):850-9. doi: 10.1101/gr.131029.111. Epub 2012 Feb 6.

  PMID: 22310478 BACKGROUND

• Kircik LH, Del Rosso JQ. Nonsteroidal treatment of atopic dermatitis in pediatric patients with a ceramide-dominant topical emulsion formulated with an optimized ratio of physiological lipids. J Clin Aesthet Dermatol. 2011 Dec;4(12):25-31.

  PMID: 22191005 BACKGROUND

• Kelleher MM, Dunn-Galvin A, Gray C, Murray DM, Kiely M, Kenny L, McLean WHI, Irvine AD, Hourihane JO. Skin barrier impairment at birth predicts food allergy at 2 years of age. J Allergy Clin Immunol. 2016 Apr;137(4):1111-1116.e8. doi: 10.1016/j.jaci.2015.12.1312.

  PMID: 26924469 BACKGROUND

• Peters RL, Allen KJ, Dharmage SC, Tang ML, Koplin JJ, Ponsonby AL, Lowe AJ, Hill D, Gurrin LC; HealthNuts Study. Skin prick test responses and allergen-specific IgE levels as predictors of peanut, egg, and sesame allergy in infants. J Allergy Clin Immunol. 2013 Oct;132(4):874-80. doi: 10.1016/j.jaci.2013.05.038. Epub 2013 Jul 24.

  PMID: 23891354 BACKGROUND

• Halken S. Prevention of allergic disease in childhood: clinical and epidemiological aspects of primary and secondary allergy prevention. Pediatr Allergy Immunol. 2004 Jun;15 Suppl 16:4-5, 9-32. doi: 10.1111/j.1399-3038.2004.0148b.x.

  PMID: 15125698 BACKGROUND

• Minasyan A, Babajanyan A, Campbell DE, Nanan R. Validation of a Comprehensive Early Childhood Allergy Questionnaire. Pediatr Allergy Immunol. 2015 Sep;26(6):522-9. doi: 10.1111/pai.12415. Epub 2015 Jul 22.

  PMID: 26031325 BACKGROUND

• Kelleher MM, O'Carroll M, Gallagher A, Murray DM, Dunn Galvin A, Irvine AD, Hourihane JO. Newborn transepidermal water loss values: a reference dataset. Pediatr Dermatol. 2013 Nov-Dec;30(6):712-6. doi: 10.1111/pde.12106. Epub 2013 Mar 5.

  PMID: 23458265 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Food Hypersensitivity

Interventions

MICU1 protein, human; Sensitivity and Specificity

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Statistics as Topic; Mathematical Concepts; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Pia Hauk, MD

  National Jewish Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Allergy Fellow

Model Details: Children at high risk of atopy will be followed up to 6 months of age. The investigator will obtain TEWL measurements, skin tape stripping, and questionnaire data each subsequent visit. During the latter 2 visits, skin prick allergy testing will be obtained for milk, egg, and peanut to determine risk of food allergy. Biologic parents will also undergo STS and TEWL measurements on the first visit.

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: March 24, 2017
• Study Start: September 30, 2017
• Primary Completion: July 30, 2018
• Study Completion: July 30, 2018
• Last Updated: June 12, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)