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

March 4, 2015 updated by: Teresa Løvold Berents, Oslo University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Teresa L Berents, MD, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

February 28, 2015

First Submitted That Met QC Criteria

March 4, 2015

First Posted (Estimate)

March 6, 2015

Study Record Updates

Last Update Posted (Estimate)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08/318b

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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