Eczema, InfantilePhase 2NCT03742414
Seal, Stopping Eczema and Allergy Study
A Phase 2 study testing Tri-lipid skin barrier cream (Epiceram) and Fluticasone propionate Cream 0.05% in people with Eczema, Infantile and Eczema, run by Kari Nadeau, MD, PhD at 5 sites in 2 countries.
Trial summary
This is a randomized, controlled trial designed for children who are have already developed atopic dermatitis (AD or eczema) by 12 weeks of age. The aim is to compare the effect of proactive sequential skin care, including the twice-daily use of a tri-lipid skin barrier cream (Epiceram) and proactive use of… Read more about this study
- Who is it for?
- Ages 1 week to 12 weeks
- Conditions the study is for
- Eczema, Infantile, Eczema, Atopic Dermatitis Eczema
- What is being tested?
- Tri-lipid skin barrier cream (Epiceram) and Fluticasone propionate Cream 0.05%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 30 Jun 2021to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 week to 12 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants who develop early onset visible dry skin or atopic dermatitis up to and equal to 12 weeks of age.
- Stated willingness to comply with all study procedures and availability for the duration of the study
- In good general health as evidenced by medical history
- No known adverse reaction to any of the study medications, their components or excipients
Who cannot join
- Infants <3kg body weight
- Infants with a chronic disease requiring therapy (e.g. heart disease, diabetes, serious neurological defects, immunodeficiency)
- Known moderate to severe cutaneous skin disorder other than AD, including but not limited to cutaneous mastocytosis, bullous skin disease, pustular skin disease, neonatal HSV, aplasia, and albinism
- Parents or guardians unwilling to sign consent
- Current participant or participation since birth in any interventional study
- Investigator or designee considers that the participant or parent/guardian would be unsuitable for inclusion in the study (for ex/ long stay in NICU)
- A course of antibiotics in infant within 7 days of enrollment
- Any known food allergies
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
University of Chicago
Chicago, Illinois, 60637
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Division of Pediatric Allergy and Clinical Immunology, National Jewish Health
Denver, Colorado, 80206
Sean N. Parker Center for Allergy & Asthma Research at Stanford University
Palo Alto, California, 94304
United Kingdom1 site
• King's College London and Guy's and St. Thomas' NHS Foundation Trust, UK
London, London
About this study
Official title: SEAL (Stopping Eczema and ALlergy) Study: Prevent the Allergic March by Enhancing the Skin Barrier
This is a randomized, controlled trial designed for children who are have already developed atopic dermatitis (AD or eczema) by 12 weeks of age. The aim is to compare the effect of proactive sequential skin care, including the twice-daily use of a tri-lipid skin barrier cream (Epiceram) and proactive use of fluticasone propionate cream, against reactive AD therapy, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).
Read the detailed description
This is a randomized, controlled, parallel design, open-label phase 2 clinical study to compare the efficacy of a proactive treatment arm versus the reactive arm, for the prevention of atopic dermatitis in children at high risk of food allergy. We will recruit 398 infants who have signs of dry skin or atopic dermatitis between 0-12 weeks of life.
The aim is to compare the effect of proactive sequential skin care, including the twice-daily use of a tri-lipid skin barrier cream (Epiceram) and proactive use of fluticasone propionate cream, against reactive AD therapy, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).
- Conditions
- Eczema, Infantile, Eczema, Atopic Dermatitis Eczema, Atopic Dermatitis
- Being tested
- Tri-lipid skin barrier cream (Epiceram), Fluticasone propionate Cream 0.05%, Standard of Care
- Keywords
- Dermatitis, Dry skin, Food allergy, Moisturizer
- Medical subject headings
- Dermatitis, Atopic, Eczema, Dermatitis, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tri-lipid skin barrier cream (Epiceram)Combination product
The aim is to compare the effect of proactive sequential skin care, including the twice daily use of a tri-lipid skin barrier cream (Epiceram) and proactive use of fluticasone proprionate cream, against reactive AD therapy, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).
Fluticasone propionate Cream 0.05%Combination product
Proactive use of fluticasone proprionate cream for inflammation of the skin, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).
Standard of CareOther
Participants' eczema will be managed by their primary physician, i.e. standard of care with routine reactive topical products for atopic dermatitis flares.
| Study group | Role | What they receive |
|---|---|---|
| Control arm (Standard of care) | Active comparator | The study doctors will provide standard of care with routine reactive topical products for atopic dermatitis flares Receives: Other: Standard of Care |
| Active Intervention arm (proactive treatment)- Epiceram | Experimental | Participants will receive proactive sequential skin care with the twice-daily use of a tri-lipid skin barrier cream (SBC). Clinically apparent eczema in this group will be managed with a short course of topical steroids (fluticasone propionate cream and/or hydrocortisone). Receives: Combination Product: Tri-lipid skin barrier cream (Epiceram); Combination Product: Fluticasone propionate Cream 0.05% |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of foods each participant is sensitized to
Sensitization is defined as food-specific IgE > 0.1 kU/L
Measured: 2 years
Secondary outcomes (4)
The per-subject cumulative number of proven Food Allergy
Double-blind placebo-controlled oral food challenges used
Measured: 2 years
Number of foods each participant is sensitized to
Sensitization is defined as food-specific skin prick test (SPT) ≥ 1 mm
Measured: 24 months of age
Number of foods each participant is sensitized to
Sensitization is defined as food-specific skin prick test (SPT) ≥ 3 mm.
Measured: 24 months of age
Presence, duration, and severity of dry skin and/or AD by clinical assessment
Patient-oriented SCORAD (PO-SCORAD) application used
Measured: Baseline, 12, and 24 months of age and as necessary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start30 Jun 2021
- Primary completion31 May 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eczema, InfantileStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, controlled, parallel design trial designed for children (total n = 398) who have already developed atopic dermatitis (AD or eczema) by 12 weeks of age. The aim is to compare the effect of proactive sequential skin care, including the twice daily use of a tri-lipid skin barrier cream (Epiceram) or moisturizer and proactive use of fluticasone proprionate cream, against reactive AD therapy, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kari Nadeau, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Jewish Health, University of Chicago, Children's Hospital Medical Center, Cincinnati, Harvard School of Public Health (HSPH), Stanford University, National Institute of Allergy and Infectious Diseases (NIAID), King's College London, Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Sponsor-investigator, Kari Nadeau, MD, PhD, Harvard School of Public Health (HSPH)
- Investigators
- Kari Nadeau, MD, PhD, Principal investigator, Harvard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742414
- Sponsor's protocol ID
- 48199
- Other IDs
- 1U01AI147462-01A1
- Status last verified
- Feb 2026
- First submitted
- 30 Oct 2018
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No current plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEAL (Stopping Eczema and ALlergy) Study: Prevent the Allergic March by Enhancing the Skin Barrier
- ClinicalTrials.gov ID
- NCT03742414
- Acronym / sponsor ID
- 48199
- Conditions
- Eczema, Infantile, Eczema, Atopic Dermatitis Eczema, Atopic Dermatitis
- Keywords
- Dermatitis, Dry skin, Food allergy, Moisturizer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 398 participants (actual)
- Lead sponsor
- Kari Nadeau, MD, PhDUniversity, hospital or other
- Collaborators
- National Jewish Health, University of Chicago, Children's Hospital Medical Center, Cincinnati, Harvard School of Public Health (HSPH), Stanford University, National Institute of Allergy and Infectious Diseases (NIAID), King's College London, Guy's and St Thomas' NHS Foundation Trust
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 15 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, controlled trial designed for children who are have already developed atopic dermatitis (AD or eczema) by 12 weeks of age. The aim is to compare the effect of proactive sequential skin care, including the twice-daily use of a tri-lipid skin barrier cream (Epiceram) and proactive use of fluticasone propionate cream, against reactive AD therapy, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).
Detailed description
This is a randomized, controlled, parallel design, open-label phase 2 clinical study to compare the efficacy of a proactive treatment arm versus the reactive arm, for the prevention of atopic dermatitis in children at high risk of food allergy. We will recruit 398 infants who have signs of dry skin or atopic dermatitis between 0-12 weeks of life.
The aim is to compare the effect of proactive sequential skin care, including the twice-daily use of a tri-lipid skin barrier cream (Epiceram) and proactive use of fluticasone propionate cream, against reactive AD therapy, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a randomized, controlled, parallel design trial designed for children (total n = 398) who have already developed atopic dermatitis (AD or eczema) by 12 weeks of age. The aim is to compare the effect of proactive sequential skin care, including the twice daily use of a tri-lipid skin barrier cream (Epiceram) or moisturizer and proactive use of fluticasone proprionate cream, against reactive AD therapy, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).
| Arm | Type | Receives |
|---|---|---|
| Control arm (Standard of care) | Active comparator | Other: Standard of CareThe study doctors will provide standard of care with routine reactive topical products for atopic dermatitis flares |
| Active Intervention arm (proactive treatment)- Epiceram | Experimental | Combination Product: Tri-lipid skin barrier cream (Epiceram), Combination Product: Fluticasone propionate Cream 0.05%Participants will receive proactive sequential skin care with the twice-daily use of a tri-lipid skin barrier cream (SBC). Clinically apparent eczema in this group will be managed with a short course of topical steroids (fluticasone propionate cream and/or hydrocortisone). |
Who may qualify
- Ages
- 1 week to 12 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Participants who develop early onset visible dry skin or atopic dermatitis up to and equal to 12 weeks of age.
- Stated willingness to comply with all study procedures and availability for the duration of the study
- In good general health as evidenced by medical history
- No known adverse reaction to any of the study medications, their components or excipients
Key exclusion criteria (8 listed)
- Infants <3kg body weight
- Infants with a chronic disease requiring therapy (e.g. heart disease, diabetes, serious neurological defects, immunodeficiency)
- Known moderate to severe cutaneous skin disorder other than AD, including but not limited to cutaneous mastocytosis, bullous skin disease, pustular skin disease, neonatal HSV, aplasia, and albinism
- Parents or guardians unwilling to sign consent
- Current participant or participation since birth in any interventional study
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 |
|---|---|---|
| Tri-lipid skin barrier cream (Epiceram)The aim is to compare the effect of proactive sequential skin care, including the twice daily use of a tri-lipid skin barrier cream (Epiceram) and proactive use of fluticasone proprionate cream, against reactive AD therapy, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA). | Combination product | Active Intervention arm (proactive treatment)- Epiceram |
| Fluticasone propionate Cream 0.05%Proactive use of fluticasone proprionate cream for inflammation of the skin, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA). | Combination product | Active Intervention arm (proactive treatment)- Epiceram |
| Standard of CareParticipants' eczema will be managed by their primary physician, i.e. standard of care with routine reactive topical products for atopic dermatitis flares. | Other | Control arm (Standard of care) |
Primary outcome
number of foods each participant is sensitized to
Time frame: 2 years
Sensitization is defined as food-specific IgE > 0.1 kU/L
4 secondary outcomes
The per-subject cumulative number of proven Food Allergy
Time frame: 2 years
Number of foods each participant is sensitized to
Time frame: 24 months of age
Number of foods each participant is sensitized to
Time frame: 24 months of age
Presence, duration, and severity of dry skin and/or AD by clinical assessment
Time frame: Baseline, 12, and 24 months of age and as necessary
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- The Sean N. Parker Center for Allergy and Asthma Research at Stanford UniversityLink provided by the sponsor.
- SEAL study informationLink provided by the sponsor.
- Individual participant dataSharing planned: No. No current plan to share data
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Active, not recruiting
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Dermatitis, Atopic, Eczema, Infantile
Not yet recruitingObservational study
Validation Of A Parent Administered Symptom Score For Unsettled Infants (Every Baby is UnIQue)
Colic, Infantile, Milk Allergy, Cow's
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.
Kari Nadeau, MD, PhD principal investigator
Harvard
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tri-lipid skin barrier cream (Epiceram) and Fluticasone propionate Cream 0.05% in people with Eczema, Infantile and Eczema, run by Kari Nadeau, MD, PhD at 5 sites in 2 countries.
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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, United Kingdom. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
number of foods each participant is sensitized to (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2026; AzTrials last refreshed its copy on 1 Nov 2026.