CompletedNCT03409367CASCADEUpdated Aug 15, 2025Results posted

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

An interventional study of Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream in Atopic Dermatitis, Atopic Disorders and Eczema, sponsored by Oregon Health and Science University. Completed at 4 sites in United States. Open to participants aged 1 Day to 63 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-15.

Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 1,260
Allocation: Randomized
Ages: 1 Day to 63 Days
Sex: All

Study 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.

Read the 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:

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.

Conditions studied

Atopic Dermatitis
Atopic Disorders
Eczema
Atopic Eczema

Browse trials for

Keywords

Prevention
Emollient
Pragmatic clinical trial

Who can participate

Ages eligible: 1 Day to 63 Days
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single group
Masking: Triple (Care provider, Investigator, Outcomes assessor)
Enrollment: 1,260 participants (actual)

Study arms

Experimental
Daily Emollient
Parent-infant dyads assigned to the intervention arm receive a lipid-rich emollient and educational materials promoting once daily full-body emollient use until the infant is 24 months old. Parents 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
No intervention
Natural Skin
Parent-infant dyads assigned to the control arm receive educational materials promoting general infant skin care guidelines only and are asked to refrain from emollient use unless dry skin develops (current standard of care guidelines).

Interventions

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

What researchers measure

Primary outcomes

Provider-diagnosed Atopic Dermatitis
The cumulative incidence of AD as recorded in health records. Trained clinicians will assess for AD at each clinic visit and record in the health record.
Time frame: up to 24 months

Secondary outcomes

Parent Report of Atopic Dermatitis
Parent or guardian reports that a clinician has diagnosed their child with atopic dermatitis (eczema) at any quarterly contact up to 24 months of age.
Time frame: up to 24 months
Atopic Dermatitis by UK Working Party Criteria
Parental report of AD using UK Working Party criteria. Parent responds "yes" to all parts of a modified version of the UK Working Party criteria at 12 and/or 24 month. Criteria include an itchy rash in flexural areas, generally dry skin, and asthma or hay fever in a first-degree relative.
Time frame: up to 24 months
Atopic Dermatitis by Children's Eczema Questionnaire
AD as diagnosed by the Children's Eczema Questionnaire (CEQ). Parent response to 3 CEQ questions is consistent with AD at 12 and/or 24 months of age.
Time frame: up to 24 months
Atopic Dermatitis With Prescription or Over-the-counter Therapies in Chart
Cumulative incidence of provider-diagnosed AD requiring prescription or over-the-counter therapies from chart review. Health records at primary care practice includes both a diagnosis of AD and prescription and/or over-the-counter (OTC) therapies. Prescription therapies could be steroids, calcineurin inhibitors, crisaborole, or antibacterials. OTC therapies could be steroids or antihistamines.
Time frame: up to 24 months
Atopic Dermatitis With or Without Prescription or Over-the-counter Therapies in Chart (Ordinal)
Ordinal coding of diagnosis of atopic dermatitis (eczema) in primary care health records, coded as none, eczema without prescription or over-the-counter (OTC) topical therapies, eczema with OTC only, or eczema with prescription therapies. Prescription therapies could be steroids, calcineurin inhibitors, crisaborole, or antibacterials. OTC therapies could be steroids or antihistamines.
Time frame: Up to 24 months
Prescribed or Over-the-counter Topical Skin Medication by Parent Report
Ordinal formulation of parent report: no AD, AD not treated with steroidal or non-steroidal cream or ointment ("therapy"), AD treated with over-the-counter (OTC) therapy, AD treated with prescription therapy. AD could be reported on annual questionnaires or quarterly contacts. Therapies reported on annual questionnaires.
Time frame: up to 24 months
Skin Infections Diagnosed and Recorded in Chart Review
Chart outcome for provider diagnosis or medications associated with skin infections, including topical antibiotics. Skin infection diagnoses include impetigo, candida, wart/verruca, molluscum, or herpes simplex.
Time frame: up to 24 months
Provider-diagnosed Asthma
Health records at primary care practice include at least one diagnosis of asthma.
Time frame: up to 24 months
Severity of AD Symptoms Using POEM
Patient-Oriented Eczema Measure (POEM) score, elicited from families of infants who reported AD diagnosis at this or any previous contact or whose CEQ response indicated AD. The POEM has seven items and ranges from 0 to 28, with higher scores reflecting more severe symptoms of AD.
Time frame: 12 months of age
Severity of AD Symptoms Using POEM
Patient-Oriented Eczema Measure (POEM) score, elicited from families of infants who reported AD diagnosis at this or any previous contact or whose CEQ response indicated AD. The POEM has seven items and ranges from 0 to 28, with higher scores reflecting more severe symptoms of AD.
Time frame: 24 months of age
Severity of AD Symptoms Using IDQoL
Symptom severity as reflected by the Infant Dermatology Quality of Life Instrument (IDQoL) elicited from families of infants who reported AD diagnosis at this or any previous contact or whose CEQ response indicated AD. The IDQoL has 12 items and ranges from 0-37 with higher scores reflecting greater adverse effect of AD on quality of life
Time frame: 12 months
Severity of AD Symptoms Using IDQoL
Symptom severity as reflected by the Infant Dermatology Quality of Life Instrument (IDQoL) elicited from families of infants who reported AD diagnosis at this or any previous contact or whose CEQ response indicated AD. The IDQoL has 12 items and ranges from 0-37 with higher scores reflecting greater adverse effect of AD on quality of life
Time frame: 24 months
Food Allergy Symptoms
Parent reports immediate food allergy reaction in child at 12- or 24-month questionnaire, or both.
Time frame: 12 months, 24 months or both
Food Allergy Diagnosis With Positive Test
Parent reports a provider diagnosis of and a positive test for food allergy at 12- or 24-month questionnaire, or both.
Time frame: up to 24 months
Primary Outcome of Provider-diagnosed Atopic Dermatitis
Diagnosis of atopic dermatitis (eczema) recorded by primary care providers in health records up to 12 months of age (rather than 24 months).
Time frame: up to 12 months
Provider-diagnosed Atopic Dermatitis at 18 Months
Diagnosis of atopic dermatitis (eczema) recorded by primary care providers in health records up to 18 months of age.
Time frame: up to 18 months

Other outcomes

Provider-diagnosed Atopic Dermatitis - Low-risk Population
Subgroup population: In the subgroup of participants who did not report atopic dermatitis in a first-degree relative, diagnosis of atopic dermatitis (eczema) recorded by primary care providers in health records
Time frame: up to 24 months
Provider-diagnosed Atopic Dermatitis - High-risk Population
Subgroup population: In the subgroup of participants who reported atopic dermatitis in a first-degree relative, diagnosis of atopic dermatitis (eczema) recorded by primary care providers in health records
Time frame: up to 24 months

Results

Posted Aug 15, 2025

Participant flow

Recruitment from 25 community-based primary care sites in four states (Oregon, North Carolina, Wisconsin, Colorado) from July 2018-February 2021.

Participant flow — Overall Study
Milestone	Daily Emollient	Natural Skin
Started	623	637
Enrolled infants	623	637
Enrolled parents	623	637
Completed	603	625
Not completed	20	12

Outcome measures

PrimaryProvider-diagnosed Atopic Dermatitis

The cumulative incidence of AD as recorded in health records. Trained clinicians will assess for AD at each clinic visit and record in the health record.

Time frame:: up to 24 months
Reported as:: Number · Participants with imputed values

Provider-diagnosed Atopic Dermatitis
Participants with imputed values	Daily Emollient	Natural Skin
Provider-diagnosed Atopic Dermatitis	217.7	268.5

Statistical analysis

Daily Emollient vs Natural Skin · Regression, log-binomial · p = 0.019 · Risk ratio (rr): 0.84 · 95% CI 0.73 to 0.97Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.

SecondaryParent Report of Atopic Dermatitis

Parent or guardian reports that a clinician has diagnosed their child with atopic dermatitis (eczema) at any quarterly contact up to 24 months of age.

Time frame:: up to 24 months
Reported as:: Number · Participants with imputed values

Parent Report of Atopic Dermatitis
Participants with imputed values	Daily Emollient	Natural Skin
Parent Report of Atopic Dermatitis	161.1	219.1

Statistical analysis

Daily Emollient vs Natural Skin · Regression, log-binomial · p = 0.002 · Risk ratio (rr): 0.76 · 95% CI 0.65 to 0.90Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.

SecondaryAtopic Dermatitis by UK Working Party Criteria

Parental report of AD using UK Working Party criteria. Parent responds "yes" to all parts of a modified version of the UK Working Party criteria at 12 and/or 24 month. Criteria include an itchy rash in flexural areas, generally dry skin, and asthma or hay fever in a first-degree relative.

Time frame:: up to 24 months
Reported as:: Number · Participants with imputed values

Atopic Dermatitis by UK Working Party Criteria
Participants with imputed values	Daily Emollient	Natural Skin
Atopic Dermatitis by UK Working Party Criteria	72.3	83.1

Statistical analysis

Daily Emollient vs Natural Skin · Regression, log-binomial · p = 0.323 (Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.) · Risk ratio (rr): 0.86 · 95% CI 0.65 to 1.15

SecondaryAtopic Dermatitis by Children's Eczema Questionnaire

AD as diagnosed by the Children's Eczema Questionnaire (CEQ). Parent response to 3 CEQ questions is consistent with AD at 12 and/or 24 months of age.

Time frame:: up to 24 months
Reported as:: Number · Participants with imputed values

Atopic Dermatitis by Children's Eczema Questionnaire
Participants with imputed values	Daily Emollient	Natural Skin
Atopic Dermatitis by Children's Eczema Questionnaire	156.9	195.3

Statistical analysis

Daily Emollient vs Natural Skin · Regression, log-binomial · p = 0.044 · Risk ratio (rr): 0.83 · 95% CI 0.70 to 0.99Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.

SecondaryAtopic Dermatitis With Prescription or Over-the-counter Therapies in Chart

Cumulative incidence of provider-diagnosed AD requiring prescription or over-the-counter therapies from chart review. Health records at primary care practice includes both a diagnosis of AD and prescription and/or over-the-counter (OTC) therapies. Prescription therapies could be steroids, calcineurin inhibitors, crisaborole, or antibacterials. OTC therapies could be steroids or antihistamines.

Time frame:: up to 24 months
Reported as:: Number · Participants with imputed values

Atopic Dermatitis With Prescription or Over-the-counter Therapies in Chart
Participants with imputed values	Daily Emollient	Natural Skin
Atopic Dermatitis With Prescription or Over-the-counter Therapies in Chart	116.5	179.8

Statistical analysis

Daily Emollient vs Natural Skin · Regression, log-binomial · p = 0.0004 · Risk ratio (rr): 0.68 · 95% CI 0.55 to 0.84Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.

SecondaryAtopic Dermatitis With or Without Prescription or Over-the-counter Therapies in Chart (Ordinal)

Ordinal coding of diagnosis of atopic dermatitis (eczema) in primary care health records, coded as none, eczema without prescription or over-the-counter (OTC) topical therapies, eczema with OTC only, or eczema with prescription therapies. Prescription therapies could be steroids, calcineurin inhibitors, crisaborole, or antibacterials. OTC therapies could be steroids or antihistamines.

Time frame:: Up to 24 months
Reported as:: Number · Participants with imputed values

Atopic Dermatitis With or Without Prescription or Over-the-counter Therapies in Chart (Ordinal)
Participants with imputed values	Daily Emollient	Natural Skin
No atopic dermatitis	385.3	356.5
Atopic dermatitis without topical medication	101.2	88.7
Atopic dermatitis with over-the-counter therapy	38.3	59.7
Atopic dermatitis with prescription therapy	78.2	120.1

Statistical analysis

Daily Emollient vs Natural Skin · Regression, proportional odds · p = 0.004 (Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations of 199 missing outcomes.) · Odds ratio (or): 0.70 · 95% CI 0.55 to 0.89

SecondaryPrescribed or Over-the-counter Topical Skin Medication by Parent Report

Ordinal formulation of parent report: no AD, AD not treated with steroidal or non-steroidal cream or ointment ("therapy"), AD treated with over-the-counter (OTC) therapy, AD treated with prescription therapy. AD could be reported on annual questionnaires or quarterly contacts. Therapies reported on annual questionnaires.

Time frame:: up to 24 months
Reported as:: Number · participants

Prescribed or Over-the-counter Topical Skin Medication by Parent Report
participants	Daily Emollient	Natural Skin
No AD	410	364
AD, no topical OTC or Rx reported	36	52
OTC topical	31	38
Rx and/or OTC topical	84	102

Statistical analysis

Daily Emollient vs Natural Skin · Regression, proportional odds · p = 0.013 · Odds ratio (or): 0.72 · 95% CI 0.56 to 0.93Adjusted for family history of atopy (stratified randomization) and primary care site.

SecondarySkin Infections Diagnosed and Recorded in Chart Review

Chart outcome for provider diagnosis or medications associated with skin infections, including topical antibiotics. Skin infection diagnoses include impetigo, candida, wart/verruca, molluscum, or herpes simplex.

Time frame:: up to 24 months
Reported as:: Count of participants · Participants

Skin Infections Diagnosed and Recorded in Chart Review
Participants	Daily Emollient	Natural Skin
Skin Infections Diagnosed and Recorded in Chart Review	101	107

Statistical analysis

Daily Emollient vs Natural Skin · Regression, log-binomial · p = 0.509 · Risk ratio (rr): 0.92 · 95% CI 0.73 to 1.17Adjusted for family history of atopy (stratified randomization) and primary care site.

SecondaryProvider-diagnosed Asthma

Health records at primary care practice include at least one diagnosis of asthma.

Time frame:: up to 24 months
Reported as:: Number · participants

Provider-diagnosed Asthma
participants	Daily Emollient	Natural Skin
Provider-diagnosed Asthma	14	13

Statistical analysis

Daily Emollient vs Natural Skin · Regression, log-binomial · p = 0.900 · Risk ratio (rr): 1.05 · 95% CI 0.50 to 2.18Adjusted for family history of atopy (stratified randomization) and primary care site.

SecondarySeverity of AD Symptoms Using POEM

Patient-Oriented Eczema Measure (POEM) score, elicited from families of infants who reported AD diagnosis at this or any previous contact or whose CEQ response indicated AD. The POEM has seven items and ranges from 0 to 28, with higher scores reflecting more severe symptoms of AD.

Time frame:: 12 months of age
Reported as:: Median · score on a scale

Severity of AD Symptoms Using POEM
score on a scale	Daily Emollient	Natural Skin
Severity of AD Symptoms Using POEM	3 (1 to 7)	2 (0 to 5)

Statistical analysis

Daily Emollient vs Natural Skin · Regression, proportional odds · p = 0.064 · Odds ratio (or): 1.47 · 95% CI 0.98 to 2.21The daily emollient is in the numerator and the natural skin is in the denominator.

SecondarySeverity of AD Symptoms Using POEM

Time frame:: 24 months of age
Reported as:: Median · score on a scale

Severity of AD Symptoms Using POEM
score on a scale	Daily Emollient	Natural Skin
Severity of AD Symptoms Using POEM	2 (0 to 5)	1 (0 to 4)

Statistical analysis

Daily Emollient vs Natural Skin · Regression, proportional odds · p = 0.007 · Odds ratio (or): 1.62 · 95% CI 1.14 to 2.30Daily emollient in the numerator and natural skin in the denominator.

SecondarySeverity of AD Symptoms Using IDQoL

Symptom severity as reflected by the Infant Dermatology Quality of Life Instrument (IDQoL) elicited from families of infants who reported AD diagnosis at this or any previous contact or whose CEQ response indicated AD. The IDQoL has 12 items and ranges from 0-37 with higher scores reflecting greater adverse effect of AD on quality of life

Time frame:: 12 months
Reported as:: Median · score on a scale

Severity of AD Symptoms Using IDQoL
score on a scale	Daily Emollient	Natural Skin
Severity of AD Symptoms Using IDQoL	4 (2 to 7)	4 (1 to 6)

Statistical analysis

Daily Emollient vs Natural Skin · Regression, proportional odds · p = 0.070 · Odds ratio (or): 1.45 · 95% CI 0.97 to 2.18Daily moisturizer is the numerator and natural skin is the denominator.

SecondarySeverity of AD Symptoms Using IDQoL

Time frame:: 24 months
Reported as:: Median · score on a scale

Severity of AD Symptoms Using IDQoL
score on a scale	Daily Emollient	Natural Skin
Severity of AD Symptoms Using IDQoL	3 (1.5 to 6)	3 (1 to 5)

Statistical analysis

Daily Emollient vs Natural Skin · Regression, proportional odds · p = 0.085 · Odds ratio (or): 1.36 · 95% CI 0.96 to 1.91Adjusted for family history of atopy (stratified randomization).

SecondaryFood Allergy Symptoms

Parent reports immediate food allergy reaction in child at 12- or 24-month questionnaire, or both.

Time frame:: 12 months, 24 months or both
Reported as:: Number · participants

Food Allergy Symptoms
participants	Daily Emollient	Natural Skin
Food Allergy Symptoms	59	77

Statistical analysis

Daily Emollient vs Natural Skin · Regression, log-binomial · p = 0.079 · Risk ratio (rr): 0.75 · 95% CI 0.55 to 1.03Adjusted for family history of atopy (stratified randomization) and primary care site.

SecondaryFood Allergy Diagnosis With Positive Test

Parent reports a provider diagnosis of and a positive test for food allergy at 12- or 24-month questionnaire, or both.

Time frame:: up to 24 months
Reported as:: Number · participants

Food Allergy Diagnosis With Positive Test
participants	Daily Emollient	Natural Skin
Food Allergy Diagnosis With Positive Test	16	18

Statistical analysis

Daily Emollient vs Natural Skin · Regression, log-binomial · p = 0.669 · Risk ratio (rr): 0.87 · 95% CI 0.45 to 1.66

SecondaryPrimary Outcome of Provider-diagnosed Atopic Dermatitis

Diagnosis of atopic dermatitis (eczema) recorded by primary care providers in health records up to 12 months of age (rather than 24 months).

Time frame:: up to 12 months
Reported as:: Count of participants · Participants

Primary Outcome of Provider-diagnosed Atopic Dermatitis
Participants	Daily Emollient	Natural Skin
Primary Outcome of Provider-diagnosed Atopic Dermatitis	115	151

Statistical analysis

Daily Emollient vs Natural Skin · Regression, log-binomial · p = 0.013 · Risk ratio (rr): 0.77 · 95% CI 0.62 to 0.95Adjusted for family history of atopy (stratified randomization) and primary care site.

SecondaryProvider-diagnosed Atopic Dermatitis at 18 Months

Diagnosis of atopic dermatitis (eczema) recorded by primary care providers in health records up to 18 months of age.

Time frame:: up to 18 months
Reported as:: Count of participants · Participants

Provider-diagnosed Atopic Dermatitis at 18 Months
Participants	Daily Emollient	Natural Skin
Provider-diagnosed Atopic Dermatitis at 18 Months	154	196

Statistical analysis

Daily Emollient vs Natural Skin · Regression, log-binomial · p = 0.009 · Risk ratio (rr): 0.80 · 95% CI 0.67 to 0.94Adjusted for family history of atopy (stratified randomization) and primary care site.

Other pre-specifiedProvider-diagnosed Atopic Dermatitis - Low-risk Population

Subgroup population: In the subgroup of participants who did not report atopic dermatitis in a first-degree relative, diagnosis of atopic dermatitis (eczema) recorded by primary care providers in health records

Time frame:: up to 24 months
Reported as:: Number · Participants with imputed values

Provider-diagnosed Atopic Dermatitis - Low-risk Population
Participants with imputed values	Daily Emollient	Natural Skin
Provider-diagnosed Atopic Dermatitis - Low-risk Population	102.1	139.7

Statistical analysis

Daily Emollient vs Natural Skin · Regression, log-binomial · p = 0.012 · Risk ratio (rr): 0.77 · 95% CI 0.63 to 0.94Adjusted for primary care site. Adjusted for multiple imputations of 121 missing outcomes.

Other pre-specifiedProvider-diagnosed Atopic Dermatitis - High-risk Population

Subgroup population: In the subgroup of participants who reported atopic dermatitis in a first-degree relative, diagnosis of atopic dermatitis (eczema) recorded by primary care providers in health records

Time frame:: up to 24 months
Reported as:: Number · Participants with imputed values

Provider-diagnosed Atopic Dermatitis - High-risk Population
Participants with imputed values	Daily Emollient	Natural Skin
Provider-diagnosed Atopic Dermatitis - High-risk Population	115.7	128.7

Statistical analysis

Daily Emollient vs Natural Skin · Regression, log-binomial · p = 0.303 · Risk ratio (rr): 0.90 · 95% CI 0.73 to 1.10Adjusted for primary care site. Adjusted for multiple imputations of 78 missing outcomes.

Adverse events

Collected over 2 years (enrollment through 24 months +/- 3 months). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Daily Emollient	1/614 (0.2%)	25/614 (4.1%)	134/614 (21.8%)
Natural Skin	1/633 (0.2%)	39/633 (6.2%)	155/633 (24.5%)

Most frequent serious events

Showing 10 of 22

Most frequent serious events
Event	Daily Emollient	Natural Skin
Breath holding spells, bronchial hyper-reactivity, bronchiolitis, croup infectious, RSV, URIRespiratory, thoracic and mediastinal disorders	9/614	16/633
Bronchitis viral, COVID-19, influenza, pneumonia, rhinovirus NOS, thrush, viral infectionInfections and infestations	4/614	6/633
Gastritis acute, gastroenteritis, gastrointestinal disorder NOS, oropharyngeal dysphagia, vomitingGastrointestinal disorders	1/614	5/633
Brain empyema, epilepsy NOS, episodic ataxia, febrile seizure, neonatal seizure disorderNervous system disorders	3/614	4/633
Acute leukemia, acute myeloid leukemia NOS, eosinophilic pustular folliculitisBlood and lymphatic system disorders	0/614	3/633
Autism spectrum disorderNervous system disorders	1/614	3/633
Skull fracture NOS, subdural haematomaInjury, poisoning and procedural complications	2/614	0/633
Choledochal cyst, neuroblastoma, Langerhans cell histiocytosisNeoplasms benign, malignant and unspecified (incl cysts and polyps)	2/614	1/633
Laryngomalacia, Kabuki make-up syndrome, macrocephalyCongenital, familial and genetic disorders	1/614	2/633
Dehydration, failure to thriveMetabolism and nutrition disorders	0/614	2/633

Most frequent other events

Showing 10 of 17

Most frequent other events
Event	Daily Emollient	Natural Skin
RashSkin and subcutaneous tissue disorders	89/614	99/633
Dermatitis contactSkin and subcutaneous tissue disorders	30/614	40/633
EczemaSkin and subcutaneous tissue disorders	22/614	26/633
Dry skinSkin and subcutaneous tissue disorders	7/614	7/633
Dermatitis diaperSkin and subcutaneous tissue disorders	0/614	6/633
Allergic reaction NOS, urticariaImmune system disorders	2/614	4/633
Seborrhoeic dermatitisSkin and subcutaneous tissue disorders	3/614	3/633
Acne infantileSkin and subcutaneous tissue disorders	2/614	3/633
Eczema exacerbatedSkin and subcutaneous tissue disorders	0/614	3/633
Skin infection / Staphylococcal skin infectionSkin and subcutaneous tissue disorders	0/614	2/633

Baseline characteristics

Parent-infant dyads contributing sufficient survey or chart data to be included in the intent-to-treat analysis. All data collected and reported relates to information about the infant. No baseline or follow-up data is collected about parents.

Age, Continuous
Age, Continuous(Days)	Daily Emollient	Natural Skin	Total
Mean	23.9 ± 16.0	24.0 ± 16.6	23.9 ± 16.3

Sex/Gender, Customized
Sex/Gender, Customized(Participants)	Daily Emollient	Natural Skin	Total
Male	324	350	674
Female	279	274	553

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Daily Emollient	Natural Skin	Total
Hispanic or Latino	144	141	285
Not Hispanic or Latino	437	459	896
Unknown or Not Reported	22	25	47

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Daily Emollient	Natural Skin	Total
American Indian or Alaska Native	13	2	15
Asian	19	16	35
Native Hawaiian or Other Pacific Islander	2	2	4
Black or African American	44	41	85
White	439	473	912
More than one race	59	53	112
Unknown or Not Reported	27	38	65

Study locations

4 sites

University of Colorado-Denver
Denver, Colorado 80045, United States
Duke University
Durham, North Carolina 27705, United States
Oregon Health & Science University
Portland, Oregon 97239, United States
University of Wisconsin-Madison
Madison, Wisconsin 53175, United States

References and documents

Publications

Simpson EL, Michaels LC, Ramsey K, Fagnan LJ, Nease DE, Henningfield M, Dolor RJ, Lapidus J, Martinez-Ziegenfuss X, Vu A, Ferrara L, Zuckerman KE, Morris CD, Williams HC; CASCADE Consortium. Emollients to Prevent Pediatric Eczema: A Randomized Clinical Trial. JAMA Dermatol. 2025 Jul 23;161(9):957-65. doi: 10.1001/jamadermatol.2025.2357. Online ahead of print. PubMed 40699587 ↗
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. PubMed 32131885 ↗

Study documents

Study protocol · Jun 4, 2021
Statistical analysis plan · Apr 18, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Data sharing will be according to the NIAMS guidelines

Supporting information: Study protocol, Sap

Registry details

Key details

Study ID: NCT03409367
Lead sponsor: Oregon Health and Science University
Collaborators: University of Wisconsin, Madison, University of Colorado, Denver, Duke University, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Responsible party: Eric Simpson (Professor, Oregon Health and Science University) — Principal investigator
First posted: Jan 24, 2018
Start date: Jul 16, 2018
Primary completion: Sep 29, 2023
Completion: Jan 31, 2024
Results posted: Aug 15, 2025
Last update: Aug 15, 2025

Study contacts

Eric Simpson, MD

principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Dermatitis, Atopic→

Other studies from this sponsor

Oregon Health and Science University

Start the discussion

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

Study summary

Conditions studied

Browse trials for

Keywords

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Other outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Study documents

Individual participant data

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria