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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02381028
Other study ID # 08/318b
Secondary ID
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


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 Visitrakā„¢ (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
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