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

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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Key information

Conditions

Atopic Eczema Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

Topical application of human milk followed by emollient

Emollient: Apobase creme® (Actavis Norway AS)

Other

Topical application of emollient

Primary outcomes

Proportional change in area of the eczema spot from baseline

Time frame: 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 outcomes

Transmission of bacteria from mother's milk to eczema spots in the child

Time frame: four weeks

The secondary outcome was to assess transmission of bacteria from mother's milk to eczema spots in the child.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Mar 6, 2015
Registry last updated: Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed