Topical Treatment With Fresh Human Milk Versus Emollient on Atopic Eczema Spots in Young Children

Topical Treatment With Fresh Human Milk Versus Emollient on Atopic Eczema Spots in Young Children: A Small, Randomized, Split Body, Controlled, Blinded Pilot Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02381028

Enrollment

Registered

2015-03-06

Start date

2008-10-31

Completion date

2010-11-30

Last updated

2015-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Eczema

Keywords

Atopic eczema, Human milk, Topical treatment, Children

Brief summary

The aim of this small pilot study is to assess the potential effects and risks of applying fresh human milk locally on eczema spots in children with atopic eczema. This is a split body, controlled, randomized and physician blinded pilot study, of children with atopic eczema with two similar contralateral eczema spots having a mother breastfeeding the child or a sibling. Fresh expressed milk and emollient is to be applied on the intervention spot and emollient alone on the control area, three times a day for four weeks. Severity and area of the eczema spots is evaluated weekly, and samples from milk and the spots were analysed weekly with respect to bacterial colonisation.

Interventions

OTHERHuman milk and emollient: Apobase creme® (Actavis Norway AS)

Topical application of human milk followed by emollient

OTHEREmollient: Apobase creme® (Actavis Norway AS)

Topical application of emollient

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

No minimum to 6 Years

Healthy volunteers

Inclusion criteria

* Children with atopic eczema according to Hanifin and Rajkas criteria with a mother breastfeeding the child or a sibling. * The eczema spots in the treatment and control areas were to be similar in features and extent as well as being localized on contralateral parts of the body.

Exclusion criteria

* Children were excluded if the severity of the eczema spots indicated need for treatment with antibiotics and/or steroids.

Design outcomes

Primary

Measure	Time frame	Description
Proportional change in area of the eczema spot from baseline	four weeks	The primary outcome was proportional change in area (cm2) of the eczema spot from baseline, as measured by Visitrak™ (Smith & Nephew), a portable device used to measure the area of wounds.

Secondary

Measure	Time frame	Description
Transmission of bacteria from mother's milk to eczema spots in the child	four weeks	The secondary outcome was to assess transmission of bacteria from mother's milk to eczema spots in the child.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026