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Baby eczema cream may stop food allergies before they start

NCT ID NCT03742414

Prevention Sponsor: Kari Nadeau, MD, PhD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether using a special skin barrier cream (Epiceram) twice a day, along with a steroid cream at the first sign of eczema, can prevent food allergies in babies who develop eczema by 12 weeks old. The goal is to see if this proactive skin care reduces the number of foods the babies become allergic to. The trial enrolled 398 infants and is currently active but no longer recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tri-lipid skin barrier cream (Epiceram) and fluticasone propionate cream
What this could lead to
If it works, this could point toward a simple skin care routine that prevents food allergies in babies with eczema.
What could go wrong
This is a Phase 2 trial, so results are still early. The approach may not prevent allergies for all babies, and steroid creams have potential side effects with long-term use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

398 people

The number who actually took part.

Started

Jun 2021

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 week to 12 weeks

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participants who develop early onset visible dry skin or atopic dermatitis up to and equal to 12 weeks of age. 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. In good general health as evidenced by medical history 4. No known adverse reaction to any of the study medications, their components or excipients Exclusion Criteria: 1. Infants \<3kg body weight 2. Infants with a chronic disease requiring therapy (e.g. heart disease, diabetes, serious neurological defects, immunodeficiency) 3. 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 4. Parents or guardians unwilling to sign consent 5. Current participant or participation since birth in any interventional study 6. Investigator or designee considers that the participant or parent/guardian would be unsuitable for inclusion in the study (for ex/ long stay in NICU) 7. A course of antibiotics in infant within 7 days of enrollment 8. Any known food allergies

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Conditions

The condition(s) this trial relates to.

atopic eczema dermatitis Eczema food allergy prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atopic dermatitis Atopic dermatitis (eczema) Eczema Eczema, infantile

Contacts and locations

Locations

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Division of Pediatric Allergy and Clinical Immunology, National Jewish Health

    Denver, Colorado, 80206, United States

  • Sean N. Parker Center for Allergy & Asthma Research at Stanford University

    Palo Alto, California, 94304, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • • King's College London and Guy's and St. Thomas' NHS Foundation Trust, UK

    London, London, United Kingdom

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