N/A N=1,260 Randomized Triple-blind Prevention

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

Atopic Dermatitis · Atopic Disorders · Eczema · Atopic Eczema

Bottom Line

View on ClinicalTrials.gov: NCT03409367 ↗

Enrolled (actual)

1,260

Serious AEs

5.1%

Results posted

Aug 2025

Primary outcome: Primary: Provider-diagnosed Atopic Dermatitis — 217.7; 268.5 Participants with imputed values — p=0.019

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream (Other)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Oregon Health and Science University
Primary completion: Sep 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Provider-diagnosed Atopic Dermatitis	217.7; 268.5	0.019 sig
SECONDARY Parent Report of Atopic Dermatitis	161.1; 219.1	0.002 sig
SECONDARY Atopic Dermatitis by UK Working Party Criteria	72.3; 83.1	0.323
SECONDARY Atopic Dermatitis by Children's Eczema Questionnaire	156.9; 195.3	0.044 sig
SECONDARY Atopic Dermatitis With Prescription or Over-the-counter Therapies in Chart	116.5; 179.8	0.0004 sig
SECONDARY Atopic Dermatitis With or Without Prescription or Over-the-counter Therapies in Chart (Ordinal)	385.3; 356.5; 101.2; 88.7; 38.3; 59.7	0.004 sig
SECONDARY Prescribed or Over-the-counter Topical Skin Medication by Parent Report	410; 364; 36; 52; 31; 38	0.013 sig
SECONDARY Skin Infections Diagnosed and Recorded in Chart Review	101; 107	0.509
SECONDARY Provider-diagnosed Asthma	14; 13	0.900
SECONDARY Severity of AD Symptoms Using POEM	2; 1	0.007 sig
SECONDARY Severity of AD Symptoms Using POEM	2; 1	0.007 sig
SECONDARY Severity of AD Symptoms Using IDQoL	3; 3	0.085
SECONDARY Severity of AD Symptoms Using IDQoL	3; 3	0.085
SECONDARY Food Allergy Symptoms	59; 77	0.079
SECONDARY Food Allergy Diagnosis With Positive Test	16; 18	0.669
SECONDARY Primary Outcome of Provider-diagnosed Atopic Dermatitis	115; 151	0.013 sig
SECONDARY Provider-diagnosed Atopic Dermatitis at 18 Months	154; 196	0.009 sig

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03409367). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.