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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-11-30

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.

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Detailed Description

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Conditions

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Atopic Eczema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Study area

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Topical application of human milk followed by emollient

Emollient: Apobase creme® (Actavis Norway AS)

Intervention Type OTHER

Topical application of emollient

Control area

Emollient: Apobase creme® (Actavis Norway AS)

Group Type ACTIVE_COMPARATOR

Emollient: Apobase creme® (Actavis Norway AS)

Intervention Type OTHER

Topical application of emollient

Interventions

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

Topical application of human milk followed by emollient

Intervention Type OTHER

Emollient: Apobase creme® (Actavis Norway AS)

Topical application of emollient

Intervention Type OTHER

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.