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Could a butyrate cream soothe eczema in kids without steroids?

NCT ID NCT07016087

Symptom relief Sponsor: Federico II University 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a special cream containing a butyrate releaser (a substance that helps the skin barrier) in 100 children aged 6-36 months with eczema. The cream was compared to a standard moisturizer over 12 weeks. The goal was to see if it could reduce eczema severity and improve skin health, offering a potential steroid-free option.

What this could mean

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

Active substance
a cream containing a butyrate releaser (postbiotic N-(1-carbamoyl-2-phenyl-ethyl) butyramide)
What this could lead to
If it works, this could offer a safe, non-steroid option to ease eczema symptoms and reduce flare-ups in young children.
What could go wrong
This is a small, completed trial with no phase designation, so results may not be conclusive. The cream is a cosmetic, not a drug, so effects may be modest.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

100 people

The number who actually took part.

Started

Oct 2024

Finished

Feb 2026

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

6 to 36 months

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: * Both sexes; * Age: 6-36 months * Caucasian ethnicity * Diagnosis of atopic dermatitis * Written informed consent of parents/legal guardians Exclusion Criteria: * Age \<6 months and \>36 months * non-Caucasian ethnicity * skin infections * ichthyosis * food allergies * chronic systemic diseases * congenital heart defects * tuberculosis * autoimmune disorders * immunodeficiency * inflammatory bowel disease * celiac disease * cystic fibrosis * metabolic disorders * neoplasms * chronic pulmonary disorders * gastrointestinal tract malformations * respiratory tract malformations * intake of systemic prebiotics/probiotics/synbiotics/immunomodulators 4 weeks prior to enrollment * treatment with topical immunomodulators (Tacrolimus or Pimecrolimus) within 3 months prior to enrollment * use of topical or systemic corticosteroids or calcineurin antagonists or phototherapy within the previous 4 weeks * investigator uncertainty about the subject's willingness or ability to comply with protocol requirements * participation in any other study involving investigational or marketed products concurrently or within two weeks prior to study entry hypersensitivity to any component of the investigational product * absence of written informed consent

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Conditions

The condition(s) this trial relates to.

atopic eczema

As listed by the trial registrant

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

Atopic dermatitis

Contacts and locations

Locations

  • Department of Traslational Medical Science - University of Naples Federico II

    Naples, Naples, 80131, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.