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Breast milk vs. baby cream: which wins for diaper rash?

NCT ID NCT07633808

Symptom relief Sponsor: University of Malaya 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares using breast milk versus zinc oxide barrier cream to treat mild-to-moderate diaper rash in 160 babies aged 0-24 months. Nurses will teach parents how to apply the treatment and track healing over 7 days. The goal is to see if breast milk, a free and natural option, works as well as commercial creams.

What this could mean

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

Active substance
breast milk (topical) and zinc oxide barrier cream
What this could lead to
If breast milk works, it could offer a free, natural option for treating mild diaper rash, especially where creams are costly or hard to get.
What could go wrong
This is a small, early-stage study with only 160 babies. Breast milk may not be as effective as standard creams, and results may not apply to all babies or settings.

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

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

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

Up to 24 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: Children aged 0 to 24 months. Diagnosis of mild-to-moderate diaper dermatitis based on clinical assessment. Caregiver willing and able to comply with study procedures and follow-up requirements. Availability of maternal breast milk for participants allocated to the maternal breast milk group. Written informed consent provided by the child's parent or legal guardian. Exclusion Criteria: * Severe diaper dermatitis requiring immediate medical treatment. Suspected or confirmed fungal, bacterial, or other secondary skin infection requiring alternative treatment. Current use of systemic antibiotics or topical medications that may interfere with outcome assessment. Known hypersensitivity or contraindication to barrier cream products used in the study. Presence of significant dermatological or medical conditions that may affect skin healing or study outcomes. Participation in another clinical study during the study period.

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Conditions

The condition(s) this trial relates to.

Diaper Rash

As listed by the trial registrant

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

Diaper dermatitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Palestinian Ministry of Health Primary Health Care Clinics

    Tulkarm, Tulkarm, Palestinian Territories

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