Atopic DermatitisCASCADENCT03409367
A Community-based Assessment of Skin Care, Allergies, and Eczema
A study testing Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream in people with Atopic Dermatitis and Atopic Disorders, run by Oregon Health and Science University at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 1 day to 63 daysHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Atopic Disorders, Eczema
- What is being tested?
- Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,260 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 Jul 2018to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 63 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Colorado-Denver
Denver, Colorado, 80045
Duke University
Durham, North Carolina, 27705
University of Wisconsin-Madison
Madison, Wisconsin, 53175
Oregon Health & Science University
Portland, Oregon, 97239
About this study
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
- Atopic Dermatitis, Atopic Disorders, Eczema, Atopic Eczema
- Being tested
- Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream
- Keywords
- Prevention, Emollient, Pragmatic clinical trial
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil creamOther
Lipid-rich emollient serving as skin barrier
| Study group | Role | What they receive |
|---|---|---|
| Daily Emollient | Experimental | 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. Receives: Other: Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream |
| Natural Skin | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24 months
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 24 months
Provider-diagnosed Asthma
Health records at primary care practice include at least one diagnosis of asthma.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 24 months
Food Allergy Symptoms
Parent reports immediate food allergy reaction in child at 12- or 24-month questionnaire, or both.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start16 Jul 2018
- Primary completion29 Sep 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This is a pragmatic, multi-site, randomized community-based trial in which dyads of a parent or legal guardian ("parent") and an infant age 0 to 2 months are enrolled. Participating dyads are randomly assigned to receive lipid-rich emollient with web-based instructions for daily use to infants plus routine skin care instructions (every day moisturizer group) or routine skin care instructions alone (natural skin group). Both groups will receive e-mail and text message reminders to follow protocol instructions based on their group allocation until the infant reaches 24 months old.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Madison, University of Colorado, Denver, Duke University, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Eric Simpson, Oregon Health and Science University
- Investigators
- Eric Simpson, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409367
- Sponsor's protocol ID
- 1R01AR071057-01A1
- Other IDs
- 1R01AR071057-01A1
- Acronym
- CASCADE
- Status last verified
- Aug 2025
- First submitted
- 11 Jan 2018
- Last updated
- 15 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing will be according to the NIAMS guidelines
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 40699587Eichner 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 at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-based Assessment of Skin Care, Allergies, and Eczema
- ClinicalTrials.gov ID
- NCT03409367
- Acronym / sponsor ID
- CASCADE / 1R01AR071057-01A1
- Conditions
- Atopic Dermatitis, Atopic Disorders, Eczema, Atopic Eczema
- Keywords
- Prevention, Emollient, Pragmatic clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,260 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- University of Wisconsin, Madison, University of Colorado, Denver, Duke University, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 24 Jan 2018 (actual)
- Results
- Posted 15 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atopic dermatitis (AD) affects over 9 million children in the U.S. and often heralds the development of asthma, food allergy, skin infections and neurodevelopmental disorders. Recent advances identify skin barrier dysfunction to be the key initiator of AD and possibly allergic sensitization.
Our central hypothesis is that daily emollient use from birth can prevent the development of AD in a community setting and into newborns unselected for risk. The results of a community-based clinical trial utilizing a pragmatic trial design will be immediately applicable to the population at large and will establish a new standard of care for all newborns.
Detailed description
AD affects over 9 million children in the U.S. and ranks first among all skin conditions in global disability burden. AD often heralds the development of several comorbidities including asthma, food allergy, skin infections and neurodevelopmental disorders. Because of the significant socioeconomic impact of atopic dermatitis and its effect on the quality of life of children and families, there have been decades of research focused on prevention with limited success. Recent advances in cutaneous biology identify epidermal defects and skin barrier dysfunction to be the key initiators of atopic dermatitis and possibly allergic sensitization. Our central hypothesis is that emollient therapy from birth can prevent the development of AD. The findings of this trial will support the development of evidence-based skin care clinical guidelines for infants that currently do not exist. Recently, our international multi-centered clinical trial found enhancing early skin barrier function with daily emollient use from birth significantly reduces the risk of AD development in high-risk populations by 50%. With CASCADE, we extend this work into the community setting and into newborns unselected for risk, so results will be immediately applicable to the population at large and will establish a new standard of care for all newborns.
The specific aims are as follows:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a pragmatic, multi-site, randomized community-based trial in which dyads of a parent or legal guardian ("parent") and an infant age 0 to 2 months are enrolled. Participating dyads are randomly assigned to receive lipid-rich emollient with web-based instructions for daily use to infants plus routine skin care instructions (every day moisturizer group) or routine skin care instructions alone (natural skin group). Both groups will receive e-mail and text message reminders to follow protocol instructions based on their group allocation until the infant reaches 24 months old.
| Arm | Type | Receives |
|---|---|---|
| Daily Emollient | Experimental | Other: Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil creamParent-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. |
| Natural Skin | No intervention | –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). |
Who may qualify
- Ages
- 1 day to 63 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil creamLipid-rich emollient serving as skin barrier | Other | Daily Emollient |
Primary outcome
Provider-diagnosed Atopic Dermatitis
Time frame: up to 24 months
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.
16 secondary outcomes
Parent Report of Atopic Dermatitis
Time frame: up to 24 months
Atopic Dermatitis by UK Working Party Criteria
Time frame: up to 24 months
Atopic Dermatitis by Children's Eczema Questionnaire
Time frame: up to 24 months
Atopic Dermatitis With Prescription or Over-the-counter Therapies in Chart
Time frame: up to 24 months
Atopic Dermatitis With or Without Prescription or Over-the-counter Therapies in Chart (Ordinal)
Time frame: Up to 24 months
Prescribed or Over-the-counter Topical Skin Medication by Parent Report
Time frame: up to 24 months
Skin Infections Diagnosed and Recorded in Chart Review
Time frame: up to 24 months
Provider-diagnosed Asthma
Time frame: up to 24 months
Severity of AD Symptoms Using POEM
Time frame: 12 months of age
Severity of AD Symptoms Using POEM
Time frame: 24 months of age
Severity of AD Symptoms Using IDQoL
Time frame: 12 months
Severity of AD Symptoms Using IDQoL
Time frame: 24 months
Food Allergy Symptoms
Time frame: 12 months, 24 months or both
Food Allergy Diagnosis With Positive Test
Time frame: up to 24 months
Primary Outcome of Provider-diagnosed Atopic Dermatitis
Time frame: up to 12 months
Provider-diagnosed Atopic Dermatitis at 18 Months
Time frame: up to 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40699587Simpson 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.
- Derived from this study: PubMed 32131885Eichner 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.
- Individual participant dataSharing planned: Yes. Data sharing will be according to the NIAMS guidelines
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Simpson, MD principal investigator
Oregon Health and Science University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream in people with Atopic Dermatitis and Atopic Disorders, run by Oregon Health and Science University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Provider-diagnosed Atopic Dermatitis (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03409367, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025; AzTrials last refreshed its copy on 26 Oct 2026.