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

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ClinicalTrials.gov Identifier: NCT02381028
Recruitment Status : Completed
First Posted : March 6, 2015
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
Teresa Løvold Berents, Oslo University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atopic Eczema Other: Human milk and emollient: Apobase creme® (Actavis Norway AS) Other: Emollient: Apobase creme® (Actavis Norway AS) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Study Start Date : October 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Rashes

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02381028


Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Teresa L Berents, MD Oslo University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Teresa Løvold Berents, Medical doctor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02381028    
Other Study ID Numbers: 08/318b
First Posted: March 6, 2015    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015
Keywords provided by Teresa Løvold Berents, Oslo University Hospital:
Atopic eczema
Human milk
Topical treatment
Children
Additional relevant MeSH terms:
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Dermatitis, Atopic
Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Emollients
Dermatologic Agents