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

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.

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 and 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.