Topical Treatment With Fresh Human Milk Versus Emollient on Atopic Eczema Spots in Young Children
1 other identifier
interventional
9
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2008
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 28, 2015
CompletedFirst Posted
Study publicly available on registry
March 6, 2015
CompletedMarch 6, 2015
March 1, 2015
2.1 years
February 28, 2015
March 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Transmission of bacteria from mother's milk to eczema spots in the child
four weeks
Study Arms (2)
Study area
EXPERIMENTALHuman milk and emollient: Apobase creme® (Actavis Norway AS)
Control area
ACTIVE COMPARATOREmollient: Apobase creme® (Actavis Norway AS)
Interventions
Topical application of human milk followed by emollient
Topical application of emollient
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Children were excluded if the severity of the eczema spots indicated need for treatment with antibiotics and/or steroids.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Berents TL, Ronnevig J, Soyland E, Gaustad P, Nylander G, Loland BF. Topical treatment with fresh human milk versus emollient on atopic eczema spots in young children: a small, randomized, split body, controlled, blinded pilot study. BMC Dermatol. 2015 May 4;15:7. doi: 10.1186/s12895-015-0027-9.
PMID: 25935520DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Teresa L Berents, MD
Oslo University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical doctor
Study Record Dates
First Submitted
February 28, 2015
First Posted
March 6, 2015
Study Start
October 1, 2008
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
March 6, 2015
Record last verified: 2015-03