Back to resultsEvaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy
Primary Purpose
Atopic Dermatitis, Eczema, Food Allergy
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Evaluating atopy in infants
Evaluating TEWL and STS in adults
Sponsored by
About this trial
This is an interventional diagnostic trial for Atopic Dermatitis focused on measuring Prevention, Predictors
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- National Jewish Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
High Risk Atopic Infants
Atopic Adults
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Serial Transepidermal Water Loss (TEWL)
Skin Barrier Assessment measured through serial transepidermal water loss (TEWL) in grams of water/meters-squared/hour
Secondary Outcome Measures
Skin Tape Stripping (STS) and Filaggrin(FLG) breakdown products
Risk of atopic dermatitis as evaluated through FLG breakdown products, lipid composition in the skin, and skin ape strip samples
Skin prick testing to milk, egg, and peanut
Food Allergen Sensitization measured by positive skin prick testing to milk, egg, and peanut measured as positive or negative
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03089476
Brief Title
Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy
Official Title
Hypothesis: Skin Barrier Dysfunction With Altered Expression of Skin Barrier Proteins and Lipids Predicts Early Food Sensitizations in Infants at High Risk of Atopy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Study will not go forward
Study Start Date
September 30, 2017 (Anticipated)
Primary Completion Date
July 30, 2018 (Anticipated)
Study Completion Date
July 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Jewish Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Eczema, Food Allergy
Keywords
Prevention, Predictors
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Risk Atopic Infants
Arm Type
Other
Arm Description
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.
Arm Title
Atopic Adults
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Evaluating atopy in infants
Other Intervention Name(s)
Atopy, Allergies
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Evaluating TEWL and STS in adults
Other Intervention Name(s)
Atopy, Transepidermal water loss, Skin tape stripping
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serial Transepidermal Water Loss (TEWL)
Description
Skin Barrier Assessment measured through serial transepidermal water loss (TEWL) in grams of water/meters-squared/hour
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Skin Tape Stripping (STS) and Filaggrin(FLG) breakdown products
Description
Risk of atopic dermatitis as evaluated through FLG breakdown products, lipid composition in the skin, and skin ape strip samples
Time Frame
Up to 12 months
Title
Skin prick testing to milk, egg, and peanut
Description
Food Allergen Sensitization measured by positive skin prick testing to milk, egg, and peanut measured as positive or negative
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
34 Weeks
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pia Hauk, MD
Organizational Affiliation
National Jewish Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16128978
Citation
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.
Results Reference
background
PubMed Identifier
22011065
Citation
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.
Results Reference
background
PubMed Identifier
24128970
Citation
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.
Results Reference
background
PubMed Identifier
7611797
Citation
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.
Results Reference
background
PubMed Identifier
24262790
Citation
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.
Results Reference
background
PubMed Identifier
25282563
Citation
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.
Results Reference
background
PubMed Identifier
25282564
Citation
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.
Results Reference
background
PubMed Identifier
22310478
Citation
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.
Results Reference
background
PubMed Identifier
22191005
Citation
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.
Results Reference
background
PubMed Identifier
26924469
Citation
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.
Results Reference
background
PubMed Identifier
23891354
Citation
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.
Results Reference
background
PubMed Identifier
15125698
Citation
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.
Results Reference
background
PubMed Identifier
26031325
Citation
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.
Results Reference
background
PubMed Identifier
23458265
Citation
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.
Results Reference
background
Learn more about this trial
Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy
We'll reach out to this number within 24 hrs