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

Atopic Eczema Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02381028
• Other study ID #: 08/318b
• Status: Completed
• Phase: N/A
• First received: February 28, 2015
• Last updated: March 4, 2015
• Start date: October 2008
• Est. completion date: November 2010

Study information

• Verified date: March 2015
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Eczema
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• Human milk and emollient: Apobase creme® (Actavis Norway AS)
Topical application of human milk followed by emollient
• Emollient: Apobase creme® (Actavis Norway AS)
Topical application of emollient

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No