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

University of Oslo (UIO)

Status: Completed

Conditions: Atopic Eczema

Treatments: Other: Human milk and emollient: Apobase creme® (Actavis Norway AS); Other: Emollient: Apobase creme® (Actavis Norway AS)

Study type: Interventional

Funder types: Other

Identifiers

NCT02381028

08/318b

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: Under 6 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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9 participants in 2 patient groups

Study area

Experimental group

Description:

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

Treatment:

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

Other: Emollient: Apobase creme® (Actavis Norway AS)

Control area

Active Comparator group

Description:

Emollient: Apobase creme® (Actavis Norway AS)

Treatment:

Other: Emollient: Apobase creme® (Actavis Norway AS)