Clinical trial NCT03409367: A Community-based Assessment of Skin Care, Allergies, and Eczema
Official title: A Community-based Assessment of Skin Care, Allergies, and Eczema
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atopic Dermatitis
Atopic Disorders
Eczema
Atopic Eczema
Keywords: Prevention
Emollient
Pragmatic clinical trial
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: University of Wisconsin, Madison
name: University of Colorado, Denver
name: Duke University
First posted: 2018-01-24
Enrollment: 1250
Sex: ALL
Minimum age (years): 0
Maximum age (years): 63
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative incidence of provider-diagnosed AD
timeFrame: up to 24 months
Secondary outcomes:
measure: Parental report of AD
timeFrame: up to 24 months
measure: AD by UK Working Party criteria
timeFrame: up to 24 months
measure: AD by Children's Eczema Questionnaire
timeFrame: up to 24 months
measure: Prescription or over-the-counter therapies for AD
timeFrame: up to 24 months
measure: Skin infections detected in chart review
timeFrame: up to 24 months
measure: Sleep loss
timeFrame: 12 and 24 months
measure: Prescribed topical skin medication
timeFrame: up to 24 months
measure: Provider-diagnosed asthma
timeFrame: up to 24 months
measure: Asthma risk
timeFrame: up to 24 months
measure: Food allergy symptoms
timeFrame: up to 24 months
measure: Reported diagnosis of food allergy
timeFrame: up to 24 months
measure: Severity of AD symptoms using POEM
timeFrame: up to 24 months
measure: Severity of AD symptoms using IDQoL
timeFrame: up to 24 months
Other outcomes:
measure: Delayed onset of AD
timeFrame: 3 months - 1 year
measure: Primary and secondary outcomes at 12 months
timeFrame: up to 12 months
measure: Age at onset
timeFrame: up to 24 months
measure: AD risk
timeFrame: up to 24 months
measure: Interaction of treatment and climate
timeFrame: up to 24 months
measure: Interaction of treatment and pets
timeFrame: up to 24 months
measure: Effect of CeraVe
timeFrame: up to 24 months
measure: Age of initiation
timeFrame: up to 24 months
measure: Bathing interaction
timeFrame: up to 24 months
measure: Caesarean birth interaction
timeFrame: up to 24 months
measure: Baby's sex
timeFrame: up to 24 months
measure: Baby's race
timeFrame: up to 24 months
measure: Baby's ethnicity
timeFrame: up to 24 months
measure: Incidence of AD at 18 months
timeFrame: up to 18 months
Locations:
city: Denver
country: United States
facility: University of Colorado-Denver
state: Colorado
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: Oregon Health and Science University
name: Eric Simpson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eichner B, Michaels LAC, Branca K, Ramsey K, Mitchell J, Morris CD, Fagnan LJ, Dolor RJ, Elder N, Hahn DL, Nease DE, Lapidus J, Cibotti R, Block J, Simpson EL. A Community-based Assessment of Skin Care, Allergies, and Eczema (CASCADE): an atopic dermatitis primary prevention study using emollients-protocol for a randomized controlled trial. Trials. 2020 Mar 4;21(1):243. doi: 10.1186/s13063-020-4150-5.