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CompletedNCT02381028Updated Mar 6, 2015

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

An interventional study of Human milk and emollient: Apobase creme® (Actavis Norway AS) and Emollient: Apobase creme® (Actavis Norway AS) in Atopic Eczema, sponsored by Oslo University Hospital. Completed. Open to participants aged Up to 6 Years. Per ClinicalTrials.gov, last updated 2015-03-06.

Sponsored by Oslo University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Randomized
Ages
Up to 6 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Atopic Eczema

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Keywords

  • Atopic eczema
  • Human milk
  • Topical treatment
  • Children
03

In context

Dermatitis, Atopic

1,443 studies on the registry are indexed under Dermatitis, Atopic; 253 are open to participants now.

This study's enrollment of 9 is below the median of 83 across 1,143 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Oslo University Hospital is the lead sponsor of 830 studies on the registry; 146 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Children were excluded if the severity of the eczema spots indicated need for treatment with antibiotics and/or steroids.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Study area

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

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

  • Active comparator
    Control area

    Emollient: Apobase creme® (Actavis Norway AS)

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

Interventions

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

    Topical application of human milk followed by emollient

  • OtherEmollient: Apobase creme® (Actavis Norway AS)

    Topical application of emollient

06

What researchers measure

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.

    Time frame: four weeks

Secondary outcomes

  1. 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.

    Time frame: four weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 25935520 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2008, a primary completion of Nov 2010 and a completion of Nov 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 28, 2015
First posted
Mar 6, 2015
Start
Oct 2008
Primary completionActual
Nov 2010
CompletionActual
Nov 2010
Last update
Mar 6, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02381028
Responsible party
Teresa Løvold Berents (Medical doctor, Oslo University Hospital) — Principal investigator
First posted
Mar 6, 2015
Start date
Oct 2008
Primary completion
Nov 2010
Completion
Nov 2010
Last update
Mar 6, 2015

Study contacts

Teresa L Berents, MD
principal investigator · Oslo University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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