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

Study Overview
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Brief Summary
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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.

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

Conditions
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Atopic Eczema

Intervention / Treatment
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* Other: Human milk and emollient: Apobase creme® (Actavis Norway AS)
* Other: Emollient: Apobase creme® (Actavis Norway AS)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study area<br>Human milk and emollient: Apobase creme® (Actavis Norway AS) | Other: Human milk and emollient: Apobase creme® (Actavis Norway AS)<br>* Topical application of human milk followed by emollient<br>Other: Emollient: Apobase creme® (Actavis Norway AS)<br>* Topical application of emollient<br>|
| Active Comparator: Control area<br>Emollient: Apobase creme® (Actavis Norway AS) | Other: Emollient: Apobase creme® (Actavis Norway AS)<br>* Topical application of emollient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportional change in area of the eczema spot from baseline | 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. | four weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic eczema, Human milk, Topical treatment, Children