Atopic DermatitisEARLYemoNCT03376243
EARLYEMOLLIENT - Feasibility of Early Emollient Use in Children With Atopic Eczema
A study testing LIPIKAR BAUME AP+ emollient in people with Atopic Dermatitis, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
The aim of this pragmatic, parallel group, assessor-blind randomised open-label prospective study is to determine the reasons that motivate parents to enrol or not enrol their child in a randomized, controlled basic emollient trial for the prevention of atopic eczema (AE). Read more about this study
- Who is it for?
- Ages 1 day to 21 daysHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- LIPIKAR BAUME AP+ emollient
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2017to 1 Jun 2021
- 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 1 day to 21 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participant (i.e. the newborn baby) must have a parent or sibling with a history of AE, allergic rhinitis or asthma.
- Infant in overall good health.
- Term-born babies
- Mother at least 18 years of age at delivery and capable of giving informed consent.
Who cannot join
- Preterm birth (defined as birth prior to 37 weeks gestation).
- Previous child randomised to this trial.
- Major congenital anomaly.
- Significant inflammatory skin disease at birth (except seborrheic dermatitis).
- Any immunodeficiency disorder or severe genetic skin disorder.
- Any condition that would make the use of emollients inadvisable or not possible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Determine the Feasibility of Early Emollient Use in Children With High Risk for Atopic Eczema - EARLYemollient
The aim of this pragmatic, parallel group, assessor-blind randomised open-label prospective study is to determine the reasons that motivate parents to enrol or not enrol their child in a randomized, controlled basic emollient trial for the prevention of atopic eczema (AE). Furthermore, this trial intends to test the hypothesis that daily skin barrier enhancement with Lipikar Baume AP+® in newborns at high risk is safe and efficient in preventing AE.
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Read the detailed description
The aim of this trial is to determine the reasons that motivate parents to enrol or not enrol their child in a randomized, controlled basic emollient trial for the prevention of AE. Furthermore, this trial intends to test the hypothesis that daily skin barrier enhancement with Lipikar Baume AP+® in babies at high risk of allergic disease is safe and to estimate the preventive effectiveness of Lipikar Baume AP+® in the prevention of AE in a high risk population.
Objectives:
The primary objectives are to investigate the
- Feasibility:
- Parental willingness to enter a child in a controlled primary prevention trial
- Compliance with intervention
- Safety: incidence of skin-related adverse events and serious adverse events during the study
- Effectiveness:
- Cumulative incidence of AE within 2 years after randomization.
- Age of onset of AE
Study design:
Pragmatic, parallel group, assessor-blind randomised open-label prospective study of emollient use in 50 high-risk neonates starting between days 1 and 21. Child participation in the main part of the trial will be 2 years (from within 3 weeks of birth until approximately the child's second birthday). This will comprise a 1 year intervention phase then the primary outcome is assessed at 2 years.
Participants:
Participants will be newborn babies at high risk of developing AE defined as a parent or sibling who has (or had) doctor diagnosed asthma, AE or allergic rhinitis.
Intervention:
The intervention is daily application of emollient to the baby's entire body surface area including the face for the first year of life. Intervention and control group will receive structured parent education that comprises general advice on best practice skin care for their baby in line with the German AWMF S3 guidelines for allergy prevention and the Federal Centre for Health Education.
Data collection:
Infants will be examined at scheduled visits at Months 1, 6, 12, and 24. Telephone visits were performed at months 3 and 18 to assess for side effects, rashes, and compliance. Daily parental recordings will be assessed using electronic data capturing tools.
Primary Outcomes:
The primary outcomes will be feasibility, safety and tolerability, and preventive effectiveness.
- Conditions
- Atopic Dermatitis
- Being tested
- LIPIKAR BAUME AP+ emollient
- Keywords
- Atopic eczema, prevention
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIPIKAR BAUME AP+ emollientOther
Structured education on prevention guidelines
| Study group | Role | What they receive |
|---|---|---|
| Emollient (LIPIKAR BAUME AP+) | Experimental | Daily application of Lipikar Baume AP+ emollient AND Structured parent education Receives: Other: LIPIKAR BAUME AP+ emollient |
| Control | No intervention | Only structured parent education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Willingness to participate
Willingness of parents to get their child randomized and to adhere to the regimen
Measured: 2 years
Secondary outcomes (3)
Development of AE
Cumulative incidence of AE
Measured: 2 years
Transepidermal water loss
Development of transepidermal water loss over time
Measured: 2 years
Microbiome diversity
Development of microbiome diversity over time
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start1 Feb 2017
- Primary completion1 Sep 2020
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- Technische Universität Dresden
- Responsible party
- Principal investigator, Prof. Dr. Stephan Weidinger, University Hospital Schleswig-Holstein
- Investigators
- Stephan Weidinger, Prof, Principal investigator, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376243
- Sponsor's protocol ID
- Earlyemollient Version 2.0
- Acronym
- EARLYemo
- Status last verified
- Sep 2021
- First submitted
- 6 Dec 2017
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Feasibility of Early Emollient Use in Children With High Risk for Atopic Eczema - EARLYemollient
- ClinicalTrials.gov ID
- NCT03376243
- Acronym / sponsor ID
- EARLYemo / Earlyemollient Version 2.0
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic eczema, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- Technische Universität Dresden
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 18 Dec 2017 (actual)
- 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 pragmatic, parallel group, assessor-blind randomised open-label prospective study is to determine the reasons that motivate parents to enrol or not enrol their child in a randomized, controlled basic emollient trial for the prevention of atopic eczema (AE). Furthermore, this trial intends to test the hypothesis that daily skin barrier enhancement with Lipikar Baume AP+® in newborns at high risk is safe and efficient in preventing AE.
T
Detailed description
The aim of this trial is to determine the reasons that motivate parents to enrol or not enrol their child in a randomized, controlled basic emollient trial for the prevention of AE. Furthermore, this trial intends to test the hypothesis that daily skin barrier enhancement with Lipikar Baume AP+® in babies at high risk of allergic disease is safe and to estimate the preventive effectiveness of Lipikar Baume AP+® in the prevention of AE in a high risk population.
Objectives:
The primary objectives are to investigate the
- Feasibility:
- Parental willingness to enter a child in a controlled primary prevention trial
- Compliance with intervention
- Safety: incidence of skin-related adverse events and serious adverse events during the study
- Effectiveness:
- Cumulative incidence of AE within 2 years after randomization.
- Age of onset of AE
Study design:
Pragmatic, parallel group, assessor-blind randomised open-label prospective study of emollient use in 50 high-risk neonates starting between days 1 and 21. Child participation in the main part of the trial will be 2 years (from within 3 weeks of birth until approximately the child's second birthday). This will comprise a 1 year intervention phase then the primary outcome is assessed at 2 years.
Participants:
Participants will be newborn babies at high risk of developing AE defined as a parent or sibling who has (or had) doctor diagnosed asthma, AE or allergic rhinitis.
Intervention:
The intervention is daily application of emollient to the baby's entire body surface area including the face for the first year of life. Intervention and control group will receive structured parent education that comprises general advice on best practice skin care for their baby in line with the German AWMF S3 guidelines for allergy prevention and the Federal Centre for Health Education.
Data collection:
Infants will be examined at scheduled visits at Months 1, 6, 12, and 24. Telephone visits were performed at months 3 and 18 to assess for side effects, rashes, and compliance. Daily parental recordings will be assessed using electronic data capturing tools.
Primary Outcomes:
The primary outcomes will be feasibility, safety and tolerability, and preventive effectiveness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emollient (LIPIKAR BAUME AP+) | Experimental | Other: LIPIKAR BAUME AP+ emollientDaily application of Lipikar Baume AP+ emollient AND Structured parent education |
| Control | No intervention | –Only structured parent education |
Who may qualify
- Ages
- 1 day to 21 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Participant (i.e. the newborn baby) must have a parent or sibling with a history of AE, allergic rhinitis or asthma.
- Infant in overall good health.
- Term-born babies
- Mother at least 18 years of age at delivery and capable of giving informed consent.
Key exclusion criteria (6 listed)
- Preterm birth (defined as birth prior to 37 weeks gestation).
- Previous child randomised to this trial.
- Major congenital anomaly.
- Significant inflammatory skin disease at birth (except seborrheic dermatitis).
- Any immunodeficiency disorder or severe genetic skin disorder.
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 |
|---|---|---|
| LIPIKAR BAUME AP+ emollientStructured education on prevention guidelines | Other | Emollient (LIPIKAR BAUME AP+) |
Primary outcome
Willingness to participate
Time frame: 2 years
Willingness of parents to get their child randomized and to adhere to the regimen
3 secondary outcomes
Development of AE
Time frame: 2 years
Transepidermal water loss
Time frame: 2 years
Microbiome diversity
Time frame: 2 years
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 28 Sep 2021.
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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.
Stephan Weidinger, Prof principal investigator
University Hospital Schleswig-Holstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIPIKAR BAUME AP+ emollient in people with Atopic Dermatitis, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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 4 inclusion and 6 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 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Willingness to participate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2021.