Back to resultsTopical Treatment With Fresh Human Milk Versus Emollient on Atopic Eczema Spots in Young Children
Primary Purpose
Atopic Eczema
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Human milk and emollient: Apobase creme® (Actavis Norway AS)
Emollient: Apobase creme® (Actavis Norway AS)
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Eczema focused on measuring Atopic eczema, Human milk, Topical treatment, Children
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study area
Control area
Arm Description
Human milk and emollient: Apobase creme® (Actavis Norway AS)
Emollient: Apobase creme® (Actavis Norway AS)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02381028
First Posted
February 28, 2015
Last Updated
March 4, 2015
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02381028
Brief Title
Topical Treatment With Fresh Human Milk Versus Emollient on Atopic Eczema Spots in Young Children
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 Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Eczema
Keywords
Atopic eczema, Human milk, Topical treatment, Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study area
Arm Type
Experimental
Arm Description
Human milk and emollient: Apobase creme® (Actavis Norway AS)
Arm Title
Control area
Arm Type
Active Comparator
Arm Description
Emollient: Apobase creme® (Actavis Norway AS)
Intervention Type
Other
Intervention Name(s)
Human milk and emollient: Apobase creme® (Actavis Norway AS)
Intervention Description
Topical application of human milk followed by emollient
Intervention Type
Other
Intervention Name(s)
Emollient: Apobase creme® (Actavis Norway AS)
Intervention Description
Topical application of emollient
Primary Outcome Measure Information:
Title
Proportional change in area of the eczema spot from baseline
Description
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.
Time Frame
four weeks
Secondary Outcome Measure Information:
Title
Transmission of bacteria from mother's milk to eczema spots in the child
Description
The secondary outcome was to assess transmission of bacteria from mother's milk to eczema spots in the child.
Time Frame
four weeks
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa L Berents, MD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
25935520
Citation
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.
Results Reference
derived
Learn more about this trial
Topical Treatment With Fresh Human Milk Versus Emollient on Atopic Eczema Spots in Young Children
We'll reach out to this number within 24 hrs