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

Not Applicable

Completed

• Conditions: Atopic Eczema

• Registration Number: NCT02381028
• Lead Sponsor: Oslo University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Study First Submitted: 2015-02-28
• Status Verified: 2015-03
• Study First Submitted QC: 2015-03-04
• Last Update Submitted: 2015-03-04
• Study First Posted: 2015-03-06
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.