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

Atopic Dermatitis Clinical Trial

— CASCADE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03409367
• Other study ID #: 1R01AR071057-01A1
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 3, 2018
• Est. completion date: February 28, 2025

Study information

• Verified date: April 2024
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 1250
• Est. completion date: February 28, 2025
• Est. primary completion date: September 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Days to 63 Days

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Atopic Disorders
• Atopic Eczema
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream
Lipid-rich emollient serving as skin barrier

Locations

Country	Name	City	State
United States	University of Colorado-Denver	Denver	Colorado
United States	Duke University	Durham	North Carolina
United States	University of Wisconsin-Madison	Madison	Wisconsin
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
Oregon Health and Science University	Duke University, University of Colorado, Denver, University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Delayed onset of AD	Is the earliest evidence of diagnosis of AD (parent report or chart review) earlier in one study arm or the other?	3 months - 1 year
Other	Primary and secondary outcomes at 12 months	Primary and secondary outcomes evaluated at 12 months (rather than 24) time frame	up to 12 months
Other	Age at onset	Parental report of eczema from quarterly contacts or annual questionnaires or provider-recorded date of first diagnosis retrieved from record review of chart indexed to the nearest quarter of follow-up	up to 24 months
Other	AD risk	Subpopulation analysis: interaction of treatment and having a family history of atopy in a first-degree relative	up to 24 months
Other	Interaction of treatment and climate	Subpopulation analysis: interaction of treatment and living in a dry climate using the average relative humidity over a year in the clinic's locality in records from the National Climate Data Center and Weather Service	up to 24 months
Other	Interaction of treatment and pets	Subpopulation: interaction of treatment and having pets or regular contact with farm animals in early childhood	up to 24 months
Other	Effect of CeraVe	Effect of CeraVe cream or ointment compared to other emollients or controls	up to 24 months
Other	Age of initiation	Baby's age at randomization (as proxy for initiation of emollient use) as moderator of treatment effect	up to 24 months
Other	Bathing interaction	Frequency of bathing (days per week) interaction with treatment effect	up to 24 months
Other	Caesarean birth interaction	Caesarean birth interaction with treatment effect	up to 24 months
Other	Baby's sex	Subpopulation: Sex of baby	up to 24 months
Other	Baby's race	Subpopulation: Race of baby	up to 24 months
Other	Baby's ethnicity	Subpopulation: Ethnicity of baby	up to 24 months
Other	Incidence of AD at 18 months	Multivariate or latent variable analysis to estimate cumulative incidence in each treatment arm using multiple candidate definitions and estimating the correlations between the definitions	up to 18 months
Primary	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	Parental report of AD	Parental report of provider-diagnosed AD	up to 24 months
Secondary	AD by UK Working Party criteria	Parental report of AD using UK Working Party criteria	up to 24 months
Secondary	AD by Children's Eczema Questionnaire	AD as diagnosed by the Children's Eczema Questionnaire (CEQ)	up to 24 months
Secondary	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
Secondary	Skin infections detected in chart review	Chart outcome for provider diagnosis or medications associated with skin infections, including topical antibiotics	up to 24 months
Secondary	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
Secondary	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
Secondary	Provider-diagnosed asthma	Asthma diagnosis from chart review	up to 24 months
Secondary	Asthma risk	Asthma risk using a modification of the Asthma Predictive Index	up to 24 months
Secondary	Food allergy symptoms	Parental report of immediate food allergy symptoms	up to 24 months
Secondary	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
Secondary	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
Secondary	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