Trial Outcomes & Findings for A Community-based Assessment of Skin Care, Allergies, and Eczema (NCT NCT03409367)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1260 participants

Primary outcome timeframe

up to 24 months

Results posted on

2025-08-15

Participant Flow

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

Participant milestones

Participant milestones
Measure	Daily Emollient Parents assigned to the intervention arm receive a lipid-rich emollient and educational materials promoting once daily full-body emollient use until infant age 24 months. Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream: Lipid-rich emollient serving as skin barrier	Natural Skin Parents assigned to the control arm receive educational materials promoting general infant skin care guidelines only and asked to refrain from emollient use unless dry skin develops (current standard of care guidelines).
Overall Study STARTED	623	637
Overall Study Enrolled Infants	623	637
Overall Study Enrolled Parents	623	637
Overall Study COMPLETED	603	625
Overall Study NOT COMPLETED	20	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Daily Emollient n=603 Participants Parents assigned to the intervention arm receive a lipid-rich emollient and educational materials promoting once daily full-body emollient use until infant age 24 months. Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream: Lipid-rich emollient serving as skin barrier	Natural Skin n=625 Participants Parents assigned to the control arm receive educational materials promoting general infant skin care guidelines only and to refrain from emollient use unless dry skin develops (current standard of care guidelines).	Total n=1228 Participants Total of all reporting groups
Age, Continuous	23.9 Days STANDARD_DEVIATION 16.0 • n=5 Participants	24.0 Days STANDARD_DEVIATION 16.6 • n=7 Participants	23.9 Days STANDARD_DEVIATION 16.3 • n=5 Participants
Sex/Gender, Customized Male	324 Participants n=5 Participants	350 Participants n=7 Participants	674 Participants n=5 Participants
Sex/Gender, Customized Female	279 Participants n=5 Participants	274 Participants n=7 Participants	553 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	144 Participants n=5 Participants	141 Participants n=7 Participants	285 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	437 Participants n=5 Participants	459 Participants n=7 Participants	896 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	22 Participants n=5 Participants	25 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	13 Participants n=5 Participants	2 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) Asian	19 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Black or African American	44 Participants n=5 Participants	41 Participants n=7 Participants	85 Participants n=5 Participants
Race (NIH/OMB) White	439 Participants n=5 Participants	473 Participants n=7 Participants	912 Participants n=5 Participants
Race (NIH/OMB) More than one race	59 Participants n=5 Participants	53 Participants n=7 Participants	112 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	27 Participants n=5 Participants	38 Participants n=7 Participants	65 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 24 months

Population: Diagnosis of atopic dermatitis recorded by primary care clinicians in health records by 24 (+/- 3) months of age. Multiple imputation of 199 missing outcomes (92 intervention, 107 control). All ITT with multiple imputation for participants with absent outcome data. Numbers represent participants per randomized arm, regardless of adherence to instructions. Counts were summarized over 15 multiple imputation datasets generated by chained equations using baseline and follow-up survey responses.

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.

Outcome measures

Outcome measures
Measure	Daily Emollient n=603 Participants Parents assigned to the intervention arm receive a lipid-rich emollient and educational materials promoting once daily full-body emollient use until infant age 24 months. Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream: Lipid-rich emollient serving as skin barrier	Natural Skin n=625 Participants Parents assigned to the control arm receive educational materials promoting general infant skin care guidelines only and asked to refrain from emollient use unless dry skin develops (current standard of care guidelines).
Provider-diagnosed Atopic Dermatitis	217.7 Participants with imputed values	268.5 Participants with imputed values

SECONDARY outcome

Timeframe: up to 24 months

Population: Multiple imputation of 111 outcomes considered missing when parent did not respond at 21 or 24 months and no diagnosis had been reported at earlier contacts. All ITT with multiple imputation for 9% of participants with absent outcome data. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. Counts were summarized over 15 multiple imputation datasets generated by chained equations using baseline and follow-up survey responses.

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.

Outcome measures

Outcome measures
Measure	Daily Emollient n=603 Participants Parents assigned to the intervention arm receive a lipid-rich emollient and educational materials promoting once daily full-body emollient use until infant age 24 months. Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream: Lipid-rich emollient serving as skin barrier	Natural Skin n=625 Participants Parents assigned to the control arm receive educational materials promoting general infant skin care guidelines only and asked to refrain from emollient use unless dry skin develops (current standard of care guidelines).
Parent Report of Atopic Dermatitis	161.1 Participants with imputed values	219.1 Participants with imputed values

SECONDARY outcome

Timeframe: up to 24 months

Population: Multiple imputation of 148 outcomes considered missing when parent did not respond at 24 months and the previous 12-month contact was not positive for AD by these criteria. All ITT with multiple imputation for 12% of participants with absent outcome data. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. Counts were summarized over 15 multiple imputation datasets generated by chained equations using baseline and follow-up survey responses.

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.

Outcome measures

Outcome measures
Measure	Daily Emollient n=603 Participants Parents assigned to the intervention arm receive a lipid-rich emollient and educational materials promoting once daily full-body emollient use until infant age 24 months. Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream: Lipid-rich emollient serving as skin barrier	Natural Skin n=625 Participants Parents assigned to the control arm receive educational materials promoting general infant skin care guidelines only and asked to refrain from emollient use unless dry skin develops (current standard of care guidelines).
Atopic Dermatitis by UK Working Party Criteria	72.3 Participants with imputed values	83.1 Participants with imputed values

SECONDARY outcome

Timeframe: up to 24 months

Population: Multiple imputation of 136 outcomes considered missing when parent did not respond at 24 months and the previous 12-month contact was not positive for AD by these criteria. All ITT with multiple imputation for 11% of participants with absent outcome data. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. Counts were summarized over 15 multiple imputation datasets generated by chained equations using baseline and follow-up survey responses.

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.

Outcome measures

Outcome measures
Measure	Daily Emollient n=603 Participants Parents assigned to the intervention arm receive a lipid-rich emollient and educational materials promoting once daily full-body emollient use until infant age 24 months. Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream: Lipid-rich emollient serving as skin barrier	Natural Skin n=625 Participants Parents assigned to the control arm receive educational materials promoting general infant skin care guidelines only and asked to refrain from emollient use unless dry skin develops (current standard of care guidelines).
Atopic Dermatitis by Children's Eczema Questionnaire	156.9 Participants with imputed values	195.3 Participants with imputed values

SECONDARY outcome

Timeframe: up to 24 months

Population: Multiple imputation of 199 missing outcomes. All ITT with multiple imputation for 16% of participants with absent outcome data. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. Counts were summarized over 15 multiple imputation datasets generated by chained equations using baseline and follow-up survey responses.

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.

Outcome measures

Outcome measures
Measure	Daily Emollient n=603 Participants Parents assigned to the intervention arm receive a lipid-rich emollient and educational materials promoting once daily full-body emollient use until infant age 24 months. Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream: Lipid-rich emollient serving as skin barrier	Natural Skin n=625 Participants Parents assigned to the control arm receive educational materials promoting general infant skin care guidelines only and asked to refrain from emollient use unless dry skin develops (current standard of care guidelines).
Atopic Dermatitis With Prescription or Over-the-counter Therapies in Chart	116.5 Participants with imputed values	179.8 Participants with imputed values

SECONDARY outcome

Timeframe: Up to 24 months

Population: All ITT with multiple imputation for 16% of participants with absent outcome data. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. Counts were summarized over 15 multiple imputation datasets generated by chained equations using baseline and follow-up survey responses.

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.

Outcome measures

Outcome measures
Measure	Daily Emollient n=603 Participants Parents assigned to the intervention arm receive a lipid-rich emollient and educational materials promoting once daily full-body emollient use until infant age 24 months. Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream: Lipid-rich emollient serving as skin barrier	Natural Skin n=625 Participants Parents assigned to the control arm receive educational materials promoting general infant skin care guidelines only and asked to refrain from emollient use unless dry skin develops (current standard of care guidelines).
Atopic Dermatitis With or Without Prescription or Over-the-counter Therapies in Chart (Ordinal) No atopic dermatitis	385.3 Participants with imputed values	356.5 Participants with imputed values
Atopic Dermatitis With or Without Prescription or Over-the-counter Therapies in Chart (Ordinal) Atopic dermatitis without topical medication	101.2 Participants with imputed values	88.7 Participants with imputed values
Atopic Dermatitis With or Without Prescription or Over-the-counter Therapies in Chart (Ordinal) Atopic dermatitis with over-the-counter therapy	38.3 Participants with imputed values	59.7 Participants with imputed values
Atopic Dermatitis With or Without Prescription or Over-the-counter Therapies in Chart (Ordinal) Atopic dermatitis with prescription therapy	78.2 Participants with imputed values	120.1 Participants with imputed values

SECONDARY outcome

Timeframe: up to 24 months

Population: Participants with (a) a parent report of provider diagnosis from an annual questionnaire or quarterly contact or (b) if no diagnosis, a parent response to a quarterly or annual contact at 21 to 24 months. Numbers represent participants according to arm randomized, regardless of adherence to study instructions.

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.

Outcome measures

Outcome measures
Measure	Daily Emollient n=561 Participants Parents assigned to the intervention arm receive a lipid-rich emollient and educational materials promoting once daily full-body emollient use until infant age 24 months. Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream: Lipid-rich emollient serving as skin barrier	Natural Skin n=556 Participants Parents assigned to the control arm receive educational materials promoting general infant skin care guidelines only and asked to refrain from emollient use unless dry skin develops (current standard of care guidelines).
Prescribed or Over-the-counter Topical Skin Medication by Parent Report No AD	410 participants	364 participants
Prescribed or Over-the-counter Topical Skin Medication by Parent Report AD, no topical OTC or Rx reported	36 participants	52 participants
Prescribed or Over-the-counter Topical Skin Medication by Parent Report OTC topical	31 participants	38 participants
Prescribed or Over-the-counter Topical Skin Medication by Parent Report Rx and/or OTC topical	84 participants	102 participants

SECONDARY outcome

Timeframe: up to 24 months

Population: All participants with (a) at least one primary care visit between 20 and 27 months of age or (b) a skin infection diagnosis earlier than 20 months. Numbers represent participants according to arm randomized, regardless of adherence to study instructions.

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.

Outcome measures

Outcome measures
Measure	Daily Emollient n=509 Participants Parents assigned to the intervention arm receive a lipid-rich emollient and educational materials promoting once daily full-body emollient use until infant age 24 months. Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream: Lipid-rich emollient serving as skin barrier	Natural Skin n=506 Participants Parents assigned to the control arm receive educational materials promoting general infant skin care guidelines only and asked to refrain from emollient use unless dry skin develops (current standard of care guidelines).
Skin Infections Diagnosed and Recorded in Chart Review	101 Participants	107 Participants

SECONDARY outcome

Timeframe: up to 24 months

Population: All participants with (a) at least one primary care visit between 20 and 27 months of age or (b) asthma diagnosis earlier than 20 months. Numbers represent participants according to arm randomized, regardless of adherence to study instructions.

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

Outcome measures

Outcome measures
Measure	Daily Emollient n=503 Participants Parents assigned to the intervention arm receive a lipid-rich emollient and educational materials promoting once daily full-body emollient use until infant age 24 months. Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream: Lipid-rich emollient serving as skin barrier	Natural Skin n=494 Participants Parents assigned to the control arm receive educational materials promoting general infant skin care guidelines only and asked to refrain from emollient use unless dry skin develops (current standard of care guidelines).
Provider-diagnosed Asthma	14 participants	13 participants

SECONDARY outcome

Timeframe: 12 months of age

Population: Respondents to 12-month questionnaires who reported a provider diagnosis of AD in the same questionnaire or at a quarterly contact, or whose response to the CEQ indicated AD. Numbers represent participants according to arm randomized, regardless of adherence to study instructions.

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.

Outcome measures

Outcome measures
Measure	Daily Emollient n=128 Participants Parents assigned to the intervention arm receive a lipid-rich emollient and educational materials promoting once daily full-body emollient use until infant age 24 months. Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream: Lipid-rich emollient serving as skin barrier	Natural Skin n=165 Participants Parents assigned to the control arm receive educational materials promoting general infant skin care guidelines only and asked to refrain from emollient use unless dry skin develops (current standard of care guidelines).
Severity of AD Symptoms Using POEM	3 score on a scale Interval 1.0 to 7.0	2 score on a scale Interval 0.0 to 5.0

SECONDARY outcome

Timeframe: 24 months of age

Population: Respondents to 24-month questionnaires who reported a provider diagnosis of AD in the same or previous annual questionnaire or at a quarterly contact, or whose response to the CEQ indicated AD. Numbers represent participants according to arm randomized, regardless of adherence to study instructions.

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.

Outcome measures

Outcome measures
Measure	Daily Emollient n=185 Participants Parents assigned to the intervention arm receive a lipid-rich emollient and educational materials promoting once daily full-body emollient use until infant age 24 months. Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream: Lipid-rich emollient serving as skin barrier	Natural Skin n=216 Participants Parents assigned to the control arm receive educational materials promoting general infant skin care guidelines only and asked to refrain from emollient use unless dry skin develops (current standard of care guidelines).
Severity of AD Symptoms Using POEM	2 score on a scale Interval 0.0 to 5.0	1 score on a scale Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: 12 months

Population: Respondents to 12-month questionnaires who reported a provider diagnosis of AD in the same questionnaire or at a quarterly contact, or whose response to the CEQ indicated AD. Numbers represent participants according to arm randomized, regardless of adherence to study instructions.

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

Outcome measures

Outcome measures
Measure	Daily Emollient n=128 Participants Parents assigned to the intervention arm receive a lipid-rich emollient and educational materials promoting once daily full-body emollient use until infant age 24 months. Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream: Lipid-rich emollient serving as skin barrier	Natural Skin n=165 Participants Parents assigned to the control arm receive educational materials promoting general infant skin care guidelines only and asked to refrain from emollient use unless dry skin develops (current standard of care guidelines).
Severity of AD Symptoms Using IDQoL	4 score on a scale Interval 2.0 to 7.0	4 score on a scale Interval 1.0 to 6.0

SECONDARY outcome

Timeframe: 24 months

Population: Respondents to 24-month questionnaires who reported a provider diagnosis of AD in the same questionnaire or at a quarterly contact, or whose response to the CEQ indicated AD. Numbers represent participants according to arm randomized, regardless of adherence to study instructions.

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

Outcome measures

Outcome measures
Measure	Daily Emollient n=184 Participants Parents assigned to the intervention arm receive a lipid-rich emollient and educational materials promoting once daily full-body emollient use until infant age 24 months. Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream: Lipid-rich emollient serving as skin barrier	Natural Skin n=216 Participants Parents assigned to the control arm receive educational materials promoting general infant skin care guidelines only and asked to refrain from emollient use unless dry skin develops (current standard of care guidelines).
Severity of AD Symptoms Using IDQoL	3 score on a scale Interval 1.5 to 6.0	3 score on a scale Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: 12 months, 24 months or both

Population: Respondents who answered items about immediate food allergy symptoms. Numbers represent participants according to arm randomized, regardless of adherence to study instructions.

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

Outcome measures

Outcome measures
Measure	Daily Emollient n=549 Participants Parents assigned to the intervention arm receive a lipid-rich emollient and educational materials promoting once daily full-body emollient use until infant age 24 months. Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream: Lipid-rich emollient serving as skin barrier	Natural Skin n=544 Participants Parents assigned to the control arm receive educational materials promoting general infant skin care guidelines only and asked to refrain from emollient use unless dry skin develops (current standard of care guidelines).
Food Allergy Symptoms	59 participants	77 participants

SECONDARY outcome

Timeframe: up to 24 months

Population: Respondents who answered items about immediate food allergy symptoms. Numbers represent participants according to arm randomized, regardless of adherence to study instructions.

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

Outcome measures

Outcome measures
Measure	Daily Emollient n=550 Participants Parents assigned to the intervention arm receive a lipid-rich emollient and educational materials promoting once daily full-body emollient use until infant age 24 months. Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream: Lipid-rich emollient serving as skin barrier	Natural Skin n=548 Participants Parents assigned to the control arm receive educational materials promoting general infant skin care guidelines only and asked to refrain from emollient use unless dry skin develops (current standard of care guidelines).
Food Allergy Diagnosis With Positive Test	16 participants	18 participants

SECONDARY outcome

Timeframe: up to 12 months

Population: Infants with diagnosis of atopic dermatitis at \<=12 months or with no diagnosis and at least one primary care visit in the health record after 9 months of age. Numbers represent participants according to arm randomized, regardless of adherence to study instructions.

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

Outcome measures

Outcome measures
Measure	Daily Emollient n=586 Participants Parents assigned to the intervention arm receive a lipid-rich emollient and educational materials promoting once daily full-body emollient use until infant age 24 months. Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream: Lipid-rich emollient serving as skin barrier	Natural Skin n=589 Participants Parents assigned to the control arm receive educational materials promoting general infant skin care guidelines only and asked to refrain from emollient use unless dry skin develops (current standard of care guidelines).
Primary Outcome of Provider-diagnosed Atopic Dermatitis	115 Participants	151 Participants

SECONDARY outcome

Timeframe: up to 18 months

Population: Infants with diagnosis of atopic dermatitis at \<=18 months or with no diagnosis and at least one primary care visit in the health record after 15 months of age. Numbers represent participants according to arm randomized, regardless of adherence to study instructions.

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

Outcome measures

Outcome measures
Measure	Daily Emollient n=561 Participants Parents assigned to the intervention arm receive a lipid-rich emollient and educational materials promoting once daily full-body emollient use until infant age 24 months. Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream: Lipid-rich emollient serving as skin barrier	Natural Skin n=570 Participants Parents assigned to the control arm receive educational materials promoting general infant skin care guidelines only and asked to refrain from emollient use unless dry skin develops (current standard of care guidelines).
Provider-diagnosed Atopic Dermatitis at 18 Months	154 Participants	196 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 24 months

Population: All ITT with multiple imputation for 19% of participants with absent outcome data. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. Counts were summarized over 15 multiple imputation datasets generated by chained equations using baseline and follow-up survey responses.

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

Outcome measures

Outcome measures
Measure	Daily Emollient n=307 Participants Parents assigned to the intervention arm receive a lipid-rich emollient and educational materials promoting once daily full-body emollient use until infant age 24 months. Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream: Lipid-rich emollient serving as skin barrier	Natural Skin n=322 Participants Parents assigned to the control arm receive educational materials promoting general infant skin care guidelines only and asked to refrain from emollient use unless dry skin develops (current standard of care guidelines).
Provider-diagnosed Atopic Dermatitis - Low-risk Population	102.1 Participants with imputed values	139.7 Participants with imputed values

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 24 months

Population: All ITT with multiple imputation for 13% of participants with absent outcome data. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. Counts were summarized over 15 multiple imputation datasets generated by chained equations using baseline and follow-up survey responses.

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

Outcome measures

Outcome measures
Measure	Daily Emollient n=296 Participants Parents assigned to the intervention arm receive a lipid-rich emollient and educational materials promoting once daily full-body emollient use until infant age 24 months. Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream: Lipid-rich emollient serving as skin barrier	Natural Skin n=303 Participants Parents assigned to the control arm receive educational materials promoting general infant skin care guidelines only and asked to refrain from emollient use unless dry skin develops (current standard of care guidelines).
Provider-diagnosed Atopic Dermatitis - High-risk Population	115.7 Participants with imputed values	128.7 Participants with imputed values

Adverse Events

Daily Emollient

Serious events: 25 serious events

Other events: 134 other events

Deaths: 1 deaths

Natural Skin

Serious events: 39 serious events

Other events: 155 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Director of Clinical Trials

Oregon Health & Science University

Phone: 503-764-8544

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Daily Emollient n=614 participants at risk Daily Emollients: Infants assigned to the intervention arm receive a lipid-rich emollient and educational materials promoting once daily full-body emollient use until infant age 24 months. Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream: Lipid-rich emollient serving as skin barrier.	Natural Skin n=633 participants at risk Natural Skin: Infants assigned to the control arm receive educational materials promoting general infant skin care guidelines only and asked to refrain from emollient use unless dry skin develops (current standard of care guidelines).
Blood and lymphatic system disorders Eosinophilic pustular folliculitis	0.00% 0/614 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.	0.16% 1/633 • Number of events 1 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.
Immune system disorders Allergic reaction NOS, urticaria	0.33% 2/614 • Number of events 2 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.	0.63% 4/633 • Number of events 4 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.
Skin and subcutaneous tissue disorders Acne infantile	0.33% 2/614 • Number of events 3 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.	0.47% 3/633 • Number of events 3 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/614 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.	0.16% 1/633 • Number of events 1 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.
Skin and subcutaneous tissue disorders Dermatitis contact	4.9% 30/614 • Number of events 35 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.	6.3% 40/633 • Number of events 46 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.
Skin and subcutaneous tissue disorders Dermatitis diaper	0.00% 0/614 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.	0.95% 6/633 • Number of events 6 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.
Skin and subcutaneous tissue disorders Dry skin	1.1% 7/614 • Number of events 8 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.	1.1% 7/633 • Number of events 8 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.
Skin and subcutaneous tissue disorders Eczema	3.6% 22/614 • Number of events 26 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.	4.1% 26/633 • Number of events 38 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.
Skin and subcutaneous tissue disorders Eczema exacerbated	0.00% 0/614 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.	0.47% 3/633 • Number of events 3 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.
Skin and subcutaneous tissue disorders Keratosis	0.16% 1/614 • Number of events 1 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.	0.00% 0/633 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.
Skin and subcutaneous tissue disorders Rash	14.5% 89/614 • Number of events 122 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.	15.6% 99/633 • Number of events 127 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.
Skin and subcutaneous tissue disorders Scarlet fever	0.00% 0/614 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.	0.16% 1/633 • Number of events 1 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.49% 3/614 • Number of events 3 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.	0.47% 3/633 • Number of events 3 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.00% 0/614 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.	0.16% 1/633 • Number of events 1 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.
Skin and subcutaneous tissue disorders Skin infection / Staphylococcal skin infection	0.00% 0/614 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.	0.32% 2/633 • Number of events 2 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.
Skin and subcutaneous tissue disorders Skin sensitization	0.16% 1/614 • Number of events 1 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.	0.16% 1/633 • Number of events 1 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.
Skin and subcutaneous tissue disorders Viral rash	0.00% 0/614 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.	0.16% 1/633 • Number of events 1 • 2 years (enrollment through 24 months +/- 3 months) Serious adverse events = hospitalization and new major medical condition Adverse events = reaction to a skincare product All-Cause Mortality Population included = Infants only. Serious adverse events, adverse events and all-cause mortality were not monitored/assessed for parents. All recorded events reported by participants or identified on chart audit.