A Community-based Assessment of Skin Care, Allergies, and Eczema

Not Applicable

Completed

Conditions: Atopic Dermatitis
Atopic Disorders
Eczema
Atopic Eczema

Registration Number: NCT03409367

Lead Sponsor: Oregon Health and Science University

Brief Summary: Atopic dermatitis (AD) affects over 9 million children in the U.S. and often heralds the development of asthma, food allergy, skin infections and neurodevelopmental disorders. Recent advances identify skin barrier dysfunction to be the key initiator of AD and possibly allergic sensitization.

Our central hypothesis is that daily emollient use from birth can prevent the development of AD in a community setting and into newborns unselected for risk. The results of a community-based clinical trial utilizing a pragmatic trial design will be immediately applicable to the population at large and will establish a new standard of care for all newborns.

Detailed Description: AD affects over 9 million children in the U.S. and ranks first among all skin conditions in global disability burden. AD often heralds the development of several comorbidities including asthma, food allergy, skin infections and neurodevelopmental disorders. Because of the significant socioeconomic impact of atopic dermatitis and its effect on the quality of life of children and families, there have been decades of research focused on prevention with limited success. Recent advances in cutaneous biology identify epidermal defects and skin barrier dysfunction to be the key initiators of atopic dermatitis and possibly allergic sensitization. Our central hypothesis is that emollient therapy from birth can prevent the development of AD. The findings of this trial will support the development of evidence-based skin care clinical guidelines for infants that currently do not exist. Recently, our international multi-centered clinical trial found enhancing early skin barrier function with daily emollient use from birth significantly reduces the risk of AD development in high-risk populations by 50%. With CASCADE, we extend this work into the community setting and into newborns unselected for risk, so results will be immediately applicable to the population at large and will establish a new standard of care for all newborns.

The specific aims are as follows:

1. Perform a community-based pragmatic randomized controlled trial investigating whether daily full-body emollient application starting in the first 2 months of life prevents atopic dermatitis in a real-world setting. The population for this trial consists of newborns between 0-2monthsof age, not selected for risk. Recruitment of families will occur during the course of routine care within primary care offices that are members of practice-based research networks(PBRNs).The intervention includes general skin care recommendations plus full-body daily lipid-rich emollient use. The control population will receive general skin care advice only and refrain from daily emollient use. The primary outcome will be the cumulative incidence of atopic dermatitis at age 24 months as determined by blinded clinicians trained in the diagnosis of AD. Key secondary clinical outcomes include time to disease onset and incidence of self-reported food allergy and wheeze using parental questionnaires.

2. As an exploratory aim, determine whether a family history of allergic disease and key early life exposures such as pet ownership modify the preventive effect of emollient therapy on atopic dermatitis. While the primary objective of this clinical trial is to determine the effectiveness of an emollient intervention in a real-world setting, data will be gathered on allergy history in the family and pet ownership-variables that may modify the effect of emollient therapy. Future implementation studies may target subpopulations found most likely to benefit from emollient intervention.

Twenty-five primary care clinics that participate in PBRNs from Oregon, Colorado, Wisconsin and North Carolina are the setting for the study protocol. The expected results from this project would represent a major public health breakthrough with the potential for reducing the atopic disease burden on a global scale.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1260

Inclusion Criteria

Parent can provide electronic signed and dated informed consent form.
Parent is willing and able to comply with all study procedures for the duration of the study.
Parent is a primary caretaker of an infant 0 to 2 months of age.
Parent is 18 years of age or older at time of consent.
Parent can speak, read, and write in English or Spanish.
Parent has a valid e-mail address or phone that can receive text messages
Parent has reliable access to the internet.
Infant is a patient of a participating Meta-LARC clinic site at the time of consent.

Exclusion Criteria

Infant was born at less than 25 weeks gestational age.
Infant has established eczema as diagnosed by the primary healthcare provider at clinic site of enrollment per parent report.
Infant has known adverse reaction to petrolatum-based emollients.
Infant has an immunodeficiency genetic syndrome such as Wiskott-Aldrich Syndrome or Severe Combined Immunodeficiency Syndrome.
Infant has extremely low birth weight (less than 1000g or 2.2 lbs at birth).
Infant has a sibling enrolled in the study.
Parent is unwilling or unable to comply with study procedures.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Provider-diagnosed Atopic Dermatitis	up to 24 months	The cumulative incidence of AD as recorded in health records. Trained clinicians will assess for AD at each clinic visit and record in the health record.

Secondary Outcome Measures

Name	Time	Method
Atopic Dermatitis With or Without Prescription or Over-the-counter Therapies in Chart (Ordinal)	Up to 24 months	Ordinal coding of diagnosis of atopic dermatitis (eczema) in primary care health records, coded as none, eczema without prescription or over-the-counter (OTC) topical therapies, eczema with OTC only, or eczema with prescription therapies. Prescription therapies could be steroids, calcineurin inhibitors, crisaborole, or antibacterials. OTC therapies could be steroids or antihistamines.
Prescribed or Over-the-counter Topical Skin Medication by Parent Report	up to 24 months	Ordinal formulation of parent report: no AD, AD not treated with steroidal or non-steroidal cream or ointment ("therapy"), AD treated with over-the-counter (OTC) therapy, AD treated with prescription therapy. AD could be reported on annual questionnaires or quarterly contacts. Therapies reported on annual questionnaires.
Skin Infections Diagnosed and Recorded in Chart Review	up to 24 months	Chart outcome for provider diagnosis or medications associated with skin infections, including topical antibiotics. Skin infection diagnoses include impetigo, candida, wart/verruca, molluscum, or herpes simplex.
Provider-diagnosed Asthma	up to 24 months	Health records at primary care practice include at least one diagnosis of asthma.
Parent Report of Atopic Dermatitis	up to 24 months	Parent or guardian reports that a clinician has diagnosed their child with atopic dermatitis (eczema) at any quarterly contact up to 24 months of age.
Severity of AD Symptoms Using POEM	24 months of age	Patient-Oriented Eczema Measure (POEM) score, elicited from families of infants who reported AD diagnosis at this or any previous contact or whose CEQ response indicated AD. The POEM has seven items and ranges from 0 to 28, with higher scores reflecting more severe symptoms of AD.
Severity of AD Symptoms Using IDQoL	24 months	Symptom severity as reflected by the Infant Dermatology Quality of Life Instrument (IDQoL) elicited from families of infants who reported AD diagnosis at this or any previous contact or whose CEQ response indicated AD. The IDQoL has 12 items and ranges from 0-37 with higher scores reflecting greater adverse effect of AD on quality of life
Food Allergy Symptoms	12 months, 24 months or both	Parent reports immediate food allergy reaction in child at 12- or 24-month questionnaire, or both.
Food Allergy Diagnosis With Positive Test	up to 24 months	Parent reports a provider diagnosis of and a positive test for food allergy at 12- or 24-month questionnaire, or both.
Atopic Dermatitis by UK Working Party Criteria	up to 24 months	Parental report of AD using UK Working Party criteria. Parent responds "yes" to all parts of a modified version of the UK Working Party criteria at 12 and/or 24 month. Criteria include an itchy rash in flexural areas, generally dry skin, and asthma or hay fever in a first-degree relative.
Atopic Dermatitis With Prescription or Over-the-counter Therapies in Chart	up to 24 months	Cumulative incidence of provider-diagnosed AD requiring prescription or over-the-counter therapies from chart review. Health records at primary care practice includes both a diagnosis of AD and prescription and/or over-the-counter (OTC) therapies. Prescription therapies could be steroids, calcineurin inhibitors, crisaborole, or antibacterials. OTC therapies could be steroids or antihistamines.
Atopic Dermatitis by Children's Eczema Questionnaire	up to 24 months	AD as diagnosed by the Children's Eczema Questionnaire (CEQ). Parent response to 3 CEQ questions is consistent with AD at 12 and/or 24 months of age.
Primary Outcome of Provider-diagnosed Atopic Dermatitis	up to 12 months	Diagnosis of atopic dermatitis (eczema) recorded by primary care providers in health records up to 12 months of age (rather than 24 months).
Provider-diagnosed Atopic Dermatitis at 18 Months	up to 18 months	Diagnosis of atopic dermatitis (eczema) recorded by primary care providers in health records up to 18 months of age.

Trial Locations

Locations (4): University of Colorado-Denver
🇺🇸
Denver, Colorado, United States
Duke University
🇺🇸
Durham, North Carolina, United States
Oregon Health & Science University
🇺🇸
Portland, Oregon, United States
University of Wisconsin-Madison
🇺🇸
Madison, Wisconsin, United States
University of Colorado-Denver
🇺🇸Denver, Colorado, United States