Atopic DermatitisCARENCT04325451
Comprehending Atopic Risk Elements
An observational study of Atopic Dermatitis, run by MYOR Ltd. at 2 sites in Israel.
Trial summary
Skin barrier impairment and familial atopy have been implicated as crucial risk factors for the development of atopic dermatitis (AD). Additional risk factors have been explored, including gestational weight, height, age, familial smoking habits, proximity to urban centers and others. Read more about this study
- Who is it for?
- Ages 24 to 120 hoursHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 252 participants
- Where
- 2 sitesIsrael
- Study dates
- 3 Jun 2020to 1 May 2024
- Phase
- Observational
- 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 24 to 120 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: Neonates will be recruited from maternity wards amongst the general population within the first five days of life
Who may be able to join
- A healthy newborn delivered in a hospital setting more than 24 hours prior to enrollment \& less than 120 hours prior to enrollment
- Term and near term newborns born between 34+0 and 42+0 weeks gestational age
- Mothers must be aged >18 years
- Parents' ability to complete questionnaire(s) at defined times throughout study duration
- Parents or legal guardian provide informed written consent
Who cannot join
- Preterm birth prior to 34+0 weeks gestation
- Less than 12 hours out of the incubator
- Neonate has undergone major surgery or intends to undergo major surgery in the coming 14 days
- Neonate has an existing widespread skin condition that would make the detection and/or assessment of eczema difficult
- Neonate has been administered oral or parenteral antibiotics from birth until study enrollment
- Neonate has a serious health issue which, at parent or investigator discretion, would make it difficult for the neonate or parents to take part in the trial
- Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: An Observational Study to Determine Lifestyle, Biophysical and Environmental Risk Factors in the Development of Early-onset Pediatric Atopic Dermatitis
Skin barrier impairment and familial atopy have been implicated as crucial risk factors for the development of atopic dermatitis (AD). Additional risk factors have been explored, including gestational weight, height, age, familial smoking habits, proximity to urban centers and others. However, a comprehensive study focusing on the entire spectrum of risk factors has yet to be undertaken. Such a study could enable predictive capabilities able to inform medical professionals as to a newborn's inherent risk to develop AD, and potentially recommend appropriate preventative modalities to prevent or delay disease onset.
- Conditions
- Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether MyOR's Precision Infant Care (PIC) Algorithm accurately predicts the risk of developing atopic dermatitis
Evaluated using MyOR's Precision Infant Care (PIC) Algorithm V1.0
Measured: 24 months
Secondary outcomes (11)
To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the risk of developing AD at six months of age.
Evaluated using the UK refinement of the Hanifin and Rajka diagnostic criteria for atopic eczema.
Measured: 6 months
To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the risk of developing AD at two years of age.
Evaluated using the UK refinement of the Hanifin and Rajka diagnostic criteria for atopic eczema.
Measured: 24 months
To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the severity of AD
Assessed using the Patient-Oriented Eczema Measure (POEM) questionnaire and accompanying scoring criteria.
Measured: 6 months
To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the severity of AD
Assessed using the Patient-Oriented Eczema Measure (POEM) questionnaire and accompanying scoring criteria.
Measured: 12 months
To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the severity of AD
Assessed using the Patient-Oriented Eczema Measure (POEM) questionnaire and accompanying scoring criteria.
Measured: 24 months
3. To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the age of onset of AD
Evaluated using the UK refinement of the Hanifin and Rajka diagnostic criteria for atopic eczema.
Measured: 24 months
To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the risk of developing food allergies
Evaluated using the 2010 U.S. Food and Drug Administration Food Safety Survey Questionnaire
Measured: 12 months
To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the risk of developing food allergies
Evaluated using the 2010 U.S. Food and Drug Administration Food Safety Survey Questionnaire
Measured: 24 months
To determine whether MyOR's Precision Infant Care (PIC) Algorithm accurately predicts the risk of developing atopic dermatitis
Evaluated using MyOR's Precision Infant Care (PIC) Algorithm V1.0
Measured: 12 months
To determine whether MyOR's Precision Infant Care (PIC) Algorithm accurately predicts the risk of developing food allergies
Evaluated using MyOR's Precision Infant Care (PIC) Algorithm V1.0
Measured: 24 months
To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the risk of development AD at one year of age
Evaluated using the UK refinement of the Hanifin and Rajka diagnostic criteria for atopic eczema. .
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start3 Jun 2020
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2024 (estimated)
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- MYOR Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Meir Medical Center, The Baruch Padeh Medical Center, Poriya
- Responsible party
- Sponsor
- Investigators
- Tatiana Smolkin, MD, Principal investigator, Poriah Medical CenterTzofia Bauer, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325451
- Sponsor's protocol ID
- 0244-19-MMC
- Acronym
- CARE
- Status last verified
- Nov 2022
- First submitted
- 24 Mar 2020
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brandwein M, Gamrasni K, Landau T, Bauer-Rusek S, Smolkin T. Nurture, not nature: Impaired skin barrier in infants born to urban households. Pediatr Allergy Immunol. 2022 Oct;33(10):e13868. doi: 10.1111/pai.13868. No abstract available.
PubMed 36282128
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Determine Lifestyle, Biophysical and Environmental Risk Factors in the Development of Early-onset Pediatric Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT04325451
- Acronym / sponsor ID
- CARE / 0244-19-MMC
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (actual)
- Lead sponsor
- MYOR Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Meir Medical Center, The Baruch Padeh Medical Center, Poriya
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 27 Mar 2020 (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.
Skin barrier impairment and familial atopy have been implicated as crucial risk factors for the development of atopic dermatitis (AD). Additional risk factors have been explored, including gestational weight, height, age, familial smoking habits, proximity to urban centers and others. However, a comprehensive study focusing on the entire spectrum of risk factors has yet to be undertaken. Such a study could enable predictive capabilities able to inform medical professionals as to a newborn's inherent risk to develop AD, and potentially recommend appropriate preventative modalities to prevent or delay disease onset.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 24 to 120 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Neonates will be recruited from maternity wards amongst the general population within the first five days of life
Key inclusion criteria (5 listed)
- A healthy newborn delivered in a hospital setting more than 24 hours prior to enrollment \& less than 120 hours prior to enrollment
- Term and near term newborns born between 34+0 and 42+0 weeks gestational age
- Mothers must be aged >18 years
- Parents' ability to complete questionnaire(s) at defined times throughout study duration
- Parents or legal guardian provide informed written consent
Key exclusion criteria (7 listed)
- Preterm birth prior to 34+0 weeks gestation
- Less than 12 hours out of the incubator
- Neonate has undergone major surgery or intends to undergo major surgery in the coming 14 days
- Neonate has an existing widespread skin condition that would make the detection and/or assessment of eczema difficult
- Neonate has been administered oral or parenteral antibiotics from birth until study enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine whether MyOR's Precision Infant Care (PIC) Algorithm accurately predicts the risk of developing atopic dermatitis
Time frame: 24 months
Evaluated using MyOR's Precision Infant Care (PIC) Algorithm V1.0
11 secondary outcomes
To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the risk of developing AD at six months of age.
Time frame: 6 months
To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the risk of developing AD at two years of age.
Time frame: 24 months
To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the severity of AD
Time frame: 6 months
To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the severity of AD
Time frame: 12 months
To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the severity of AD
Time frame: 24 months
3. To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the age of onset of AD
Time frame: 24 months
To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the risk of developing food allergies
Time frame: 12 months
To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the risk of developing food allergies
Time frame: 24 months
To determine whether MyOR's Precision Infant Care (PIC) Algorithm accurately predicts the risk of developing atopic dermatitis
Time frame: 12 months
To determine whether MyOR's Precision Infant Care (PIC) Algorithm accurately predicts the risk of developing food allergies
Time frame: 24 months
To determine whether the combined information of familial history of atopy, TEWL, and other risk factors can effectively predict the risk of development AD at one year of age
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Derived from this study: PubMed 36282128Brandwein M, Gamrasni K, Landau T, Bauer-Rusek S, Smolkin T. Nurture, not nature: Impaired skin barrier in infants born to urban households. Pediatr Allergy Immunol. 2022 Oct;33(10):e13868. doi: 10.1111/pai.13868. No abstract available.
- Individual participant dataSharing planned: No
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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.
Tatiana Smolkin, MD principal investigator
Poriah Medical Center
Tzofia Bauer, MD principal investigator
Meir Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by MYOR Ltd. at 2 sites in Israel.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Results are not available in the source record.
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?
To determine whether MyOR's Precision Infant Care (PIC) Algorithm accurately predicts the risk of developing atopic dermatitis (time frame: 24 months). 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 NCT04325451, 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 3 Nov 2022.