Atopic EczemaNCT02381028
Topical Treatment With Fresh Human Milk Versus Emollient on Atopic Eczema Spots in Young Children
A study testing Human milk and emollient: Apobase creme® (Actavis Norway AS) and Emollient: Apobase creme® (Actavis Norway AS) in people with Atopic Eczema, run by Oslo University Hospital.
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… Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Atopic Eczema
- What is being tested?
- Human milk and emollient: Apobase creme® (Actavis Norway AS) and Emollient: Apobase creme® (Actavis Norway AS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Children were excluded if the severity of the eczema spots indicated need for treatment with antibiotics and/or steroids.
About this study
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
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.
- Conditions
- Atopic Eczema
- Being tested
- Human milk and emollient: Apobase creme® (Actavis Norway AS), Emollient: Apobase creme® (Actavis Norway AS)
- Keywords
- Atopic eczema, Human milk, Topical treatment, Children
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human milk and emollient: Apobase creme® (Actavis Norway AS)Other
Topical application of human milk followed by emollient
Emollient: Apobase creme® (Actavis Norway AS)Other
Topical application of emollient
| Study group | Role | What they receive |
|---|---|---|
| Study area | Experimental | Human milk and emollient: Apobase creme® (Actavis Norway AS) Receives: Other: Human milk and emollient: Apobase creme® (Actavis Norway AS); Other: Emollient: Apobase creme® (Actavis Norway AS) |
| Control area | Active comparator | Emollient: Apobase creme® (Actavis Norway AS) Receives: Other: Emollient: Apobase creme® (Actavis Norway AS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startOct 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic EczemaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Løvold Berents, Oslo University Hospital
- Investigators
- Teresa L Berents, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381028
- Sponsor's protocol ID
- 08/318b
- Status last verified
- Mar 2015
- First submitted
- 28 Feb 2015
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02381028
- Acronym / sponsor ID
- 08/318b
- Conditions
- Atopic Eczema
- Keywords
- Atopic eczema, Human milk, Topical treatment, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 6 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study area | Experimental | Other: Human milk and emollient: Apobase creme® (Actavis Norway AS), Other: Emollient: Apobase creme® (Actavis Norway AS)Human milk and emollient: Apobase creme® (Actavis Norway AS) |
| Control area | Active comparator | Other: Emollient: Apobase creme® (Actavis Norway AS)Emollient: Apobase creme® (Actavis Norway AS) |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Children were excluded if the severity of the eczema spots indicated need for treatment with antibiotics and/or steroids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human milk and emollient: Apobase creme® (Actavis Norway AS)Topical application of human milk followed by emollient | Other | Study area |
| Emollient: Apobase creme® (Actavis Norway AS)Topical application of emollient | Other | Control area, Study area |
Primary outcome
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.
1 secondary outcome
Transmission of bacteria from mother's milk to eczema spots in the child
Time frame: four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
- Derived from this study: PubMed 25935520Berents 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa L Berents, MD principal investigator
Oslo University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Human milk and emollient: Apobase creme® (Actavis Norway AS) and Emollient: Apobase creme® (Actavis Norway AS) in people with Atopic Eczema, run by Oslo University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportional change in area of the eczema spot from baseline (time frame: four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02381028, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015; AzTrials last refreshed its copy on 8 Nov 2026.