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

Study Overview
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Brief Summary
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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
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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: 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. 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.

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

Conditions
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Atopic Dermatitis, Atopic Disorders, Eczema, Atopic Eczema

Intervention / Treatment
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* Other: Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 63 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: This is a pragmatic, multi-site, randomized community-based trial in which dyads of a parent or legal guardian (parent) and an infant age 0 to 2 months are enrolled. Participating dyads are randomly assigned to receive lipid-rich emollient with web-based instructions for daily use to infants plus routine skin care instructions (every day moisturizer group) or routine skin care instructions alone (natural skin group). Both groups will receive e-mail and text message reminders to follow protocol instructions based on their group allocation until the infant reaches 24 months old.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daily Emollient<br>Parents assigned to the intervention arm will receive a lipid-rich emollient and educational materials promoting once daily full-body emollient use until their infant is 24 months old. Parents will select one of five emollients to be mailed to the dyad's home at enrollment and approximately every six months for the duration of the study. These emollients include (1) CeraVe Healing Ointment, (2) Vaseline, (3) Cetaphil cream, (4) CeraVe cream, and (5) Vanicream. | Other: Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream<br>* Lipid-rich emollient serving as skin barrier<br>|
| No Intervention: Natural Skin<br>Parents assigned to the control arm will receive educational materials promoting general infant skin care guidelines only and will be asked to refrain from emollient use unless dry skin develops (current standard of care guidelines). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of provider-diagnosed AD | The cumulative incidence of AD at 24 months of age as recorded in health records. Trained clinicians will assess for AD at each clinic visit and record in the health record. | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental report of AD | Parental report of provider-diagnosed AD | up to 24 months | 
| AD by UK Working Party criteria | Parental report of AD using UK Working Party criteria | up to 24 months | 
| AD by Children's Eczema Questionnaire | AD as diagnosed by the Children's Eczema Questionnaire (CEQ) | up to 24 months | 
| Prescription or over-the-counter therapies for AD | Cumulative incidence of provider-diagnosed AD requiring prescription or over-the-counter therapies from chart review | up to 24 months | 
| Skin infections detected in chart review | Chart outcome for provider diagnosis or medications associated with skin infections, including topical antibiotics | up to 24 months | 
| Sleep loss | Parental report of sleep loss of the infant reported as average number of days per week (1 week recall) of disrupted sleep in their infant [single item of IDQoL] | 12 and 24 months | 
| Prescribed topical skin medication | Any steroidal or non-steroidal cream or ointment, recorded by parent or recorded from records review. Evaluated in (1) all children and (2) those with AD only. | up to 24 months | 
| Provider-diagnosed asthma | Asthma diagnosis from chart review | up to 24 months | 
| Asthma risk | Asthma risk using a modification of the Asthma Predictive Index | up to 24 months | 
| Food allergy symptoms | Parental report of immediate food allergy symptoms | up to 24 months | 
| Reported diagnosis of food allergy | Parental report of a provider diagnosis of food allergy that was confirmed by prick testing or IgE blood test | up to 24 months | 
| Severity of AD symptoms using POEM | In infants who develop AD, symptom severity as reported in the patient-oriented eczema measure (POEM) instrument | up to 24 months | 
| Severity of AD symptoms using IDQoL | In infants who develop AD, symptom severity as reflected by the Infant Dermatology Quality of Life Instrument (IDQOL) | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Emollient, Pragmatic clinical trial