Eczema Atopic DermatitisSTOP ADNCT03871998
Short-term Topical Application to Prevent Atopic Dermatitis
A study testing Skin barrier protection in the first 2 months of life in people with Eczema Atopic Dermatitis and Eczema, run by University College Cork at 1 site in Ireland.
Trial summary
This is a randomised, open-label, controlled study designed to investigate the effect of short-term neonatal skin barrier protection using a commercially available moisturiser on the prevention of atopic dermatitis and food allergy in high risk children. Read more about this study
- Who is it for?
- Ages 0 to 5 daysHealthy volunteers can take part
- Conditions the study is for
- Eczema Atopic Dermatitis, Eczema, Eczema, Infantile
- What is being tested?
- Skin barrier protection in the first 2 months of life
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 321 participants
- Where
- 1 siteIreland
- Study dates
- 16 Apr 2019to 30 Nov 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 0 to 5 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy full-term infants, gestational age >36+6 weeks.
- Infant has at least one parent with self-reported atopic dermatitis, food allergy, allergic rhinitis or asthma.
- Not requiring admission to the Neonatal Unit.
Who cannot join
- No parental history of atopic disease.
- Admission to the Neonatal Unit for issues other than the establishment of normal feeding.
- Being administered oral or parenteral antibiotics.
- Receiving phototherapy for hyperbilirubinaemia.
- Sibling, including twin, already recruited.
- Other serious health issues (e.g. abdominal wall defects, congenital heart disease etc.) or a severe widespread skin condition (e.g. collodion).
- Any condition that would make the use of skin barrier protectant inadvisable or not possible (e.g. ankle talipes or developmental dysplasia of the hip, requiring a Pavlik's harness or casts).
- Participation in any other clinical trial of an investigational medicinal product.
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomised, open-label, controlled study designed to investigate the effect of short-term neonatal skin barrier protection using a commercially available moisturiser on the prevention of atopic dermatitis and food allergy in high risk children.
Read the detailed description
Eczema, also known medically as Atopic Dermatitis (AD) is the most common skin disease of childhood, affecting 20% of Irish children, and is a general term for a group of skin conditions that cause the skin to become dry, red, itchy and inflamed. AD is often the first manifestation of atopic comorbidities including food allergy, asthma and allergic rhinitis. Recently published studies suggest that skin barrier preservation, with topically applied moisturisers in the first year of life, reduces the incidence of AD. Our own data suggests that an earlier window for this skin barrier protection may exist.
This study is a randomised, open-label, controlled study and will investigate the effect of short-term neonatal skin barrier protection on the prevention of AD and food allergy in high risk infants. Infants with at least one parent with a positive history of atopic disease (AD, allergic rhinitis, asthma or food allergy) will be eligible for recruitment.
The first study visit will take place within approximately 4 days of birth in the postnatal wards. At this visit, infants will be randomised to either treatment with skin barrier protection using a commercially available moisturiser or to standard routine skincare with no moisturiser from as soon as possible after birth until 2 months of age. This visit will also involve measurements of neonatal trans-epidermal water loss (TEWL) and natural moisturising factor (NMF) to assess skin barrier function and structure. Skin swabs will also be taken for microbiome and immune biomarker analysis.
Follow-up assessments will take place at 2, 4 and 8 weeks, 6 and 12 months. Each visit will include a physical examination of the infant's skin, including TEWL and NMF measurements, and a questionnaire on infant health, bathing and skincare.
Infant skin swabs will be taken again at 8 weeks and 12 months. A research nurse or doctor, blind to treatment allocation, will administer standardised assessments for the presence (yes/no), extent and severity of AD at 6 and 12 months. Suspected cases of food allergy will be investigated using skin prick testing (SPT) and oral food challenges.
A DNA sample will be taken to test for filaggrin loss-of-function mutations, which are linked to AD risk.
The primary outcome is AD at 12 months.
- Conditions
- Eczema Atopic Dermatitis, Eczema, Eczema, Infantile, Food Allergy
- Being tested
- Skin barrier protection in the first 2 months of life
- Keywords
- Eczema, Atopic dermatitis, Food allergy, Skin barrier, Filaggrin, Natural moisturizing factor, TEWL, Skin microbiome, Prevention, Moisturizer
- Medical subject headings
- Eczema, Dermatitis, Atopic, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin barrier protection in the first 2 months of lifeOther
Skin barrier protection in the first 2 months of life using a commercially available moisturiser from birth 2 months. Twice daily, whole-body application.
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | Skin barrier protection in the first 2 months of life. Receives: Other: Skin barrier protection in the first 2 months of life |
| Control arm | No intervention | Standard skincare advice. No moisturiser in the first 2 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of atopic dermatitis at 12 months.
Measured: 12 months
Cumulative incidence of IgE-mediated food allergy at 2 years
Measured: 2 years
Secondary outcomes (8)
Longitudinal changes in transepidermal water loss (TEWL) from birth to 12 months
TEWL measured at birth, 2, 4 and 8 weeks and at 6 and 12 months.
Measured: Birth to 12 months
Longitudinal changes in natural moisturising factor (NMF) in the stratum corneum from birth to 12 months.
NMF measured by Raman spectroscopy at birth, 2, 4 and 8 weeks and at 6 and 12 months.
Measured: Birth to 12 months
Microbial diversity and richness of the cheek and antecubital fossa (study subset).
Microbial community analysis (identification and abundance of a taxonomic units) will be used for the calculations of population diversity and richness indices (rarefaction, Shannon index, abundance-based coverage estimators (ACE), and Chao1) in a subset of study participants (n = 30 per study group).
Measured: Skin swabs for microbiome analysis will be taken at baseline (0-4 days), 8 weeks and 12 months.
Changes in skin microbial diversity and richness over the first year of life.
Comparison of microbial diversity and richness of the cheek and antecubital fossa between baseline, 8 weeks and 12 months (n = 30 per study group).
Measured: Skin swabs for microbiome analysis will be taken at baseline (0-4 days), 8 weeks and 12 months.
Comparison of microbial diversity and richness between the intervention and control groups.
Comparison of microbial diversity and richness of the cheek and antecubital fossa at each timepoint between the intervention (moisturiser) and control (no moisturiser) groups (n = 30 per study group).
Measured: Skin swabs for microbiome analysis will be taken at baseline (0-4 days), 8 weeks and 12 months.
Skin biomarker profile analysis of the cheek and antecubital fossa (study subset).
Cheek and antecubital fossa skin biomarker analysis, including interleukins, chemokines. and antimicrobial peptides (final list to be established) at birth, 8 weeks and 12 months (n = 30 from each study group).
Measured: Skin swabs for biomarker analysis will be taken at baseline (0-4 days), 8 weeks and 12 months.
Changes in skin biomarker profile between study over the first year of life.
Comparison of skin biomarker profiles of the cheek and antecubital fossa between baseline, 8 weeks and 12 months (n = 30 per study group).
Measured: Skin swabs for biomarker analysis will be taken at baseline (0-4 days), 8 weeks and 12 months.
Comparison of skin biomarker profiles between the intervention and control groups.
Comparison of skin biomarker profiles of the cheek and antecubital fossa at each timepoint between the intervention (moisturiser) and control (no moisturiser) groups (n = 30 per group).
Measured: Skin swabs for biomarker analysis will be taken at baseline (0-4 days), 8 weeks and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start16 Apr 2019
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eczema 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
- Model description
- Single-centre, randomised, open-label, controlled study to evaluate whether short-term skin barrier protection using a moisturizer from birth to 2 months can prevent the onset of atopic dermatitis and food allergy at 12 months. Assessments of atopic dermatitis will be blinded.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Hourihane, University College Cork
- Investigators
- Jonathan O'B Hourihane, MD, Principal investigator, Royal College of Surgeons in Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871998
- Sponsor's protocol ID
- STOP AD
- Acronym
- STOP AD
- Status last verified
- Jun 2022
- First submitted
- 7 Mar 2019
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Puppels GJ, Hourihane JO, Nico C, Chaoimh CN, Wong C, Common JE, Caspers PJ, Irvine AD. Highly accurate, noninvasive early identification of infants with a filaggrin loss-of-function mutation by in vivo Raman spectroscopy, followed from birth to 12 months. Ann Allergy Asthma Immunol. 2025 Apr;134(4):457-464. doi: 10.1016/j.anai.2025.01.010. Epub 2025 Jan 16.
PubMed 39826898Stamatas GN, Sato T, Chaoimh CN, Oddos T, Insel R, Hourihane JO, Irvine AD. Early skin inflammatory biomarker is predictive of development and persistence of atopic dermatitis in infants. J Allergy Clin Immunol. 2024 Jun;153(6):1597-1603.e4. doi: 10.1016/j.jaci.2024.02.018. Epub 2024 Mar 7.
PubMed 38460678
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Topical Application to Prevent Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03871998
- Acronym / sponsor ID
- STOP AD / STOP AD
- Conditions
- Eczema Atopic Dermatitis, Eczema, Eczema, Infantile, Food Allergy
- Keywords
- Eczema, Atopic dermatitis, Food allergy, Skin barrier, Filaggrin, Natural moisturizing factor, TEWL, Skin microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 12 Mar 2019 (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.
This is a randomised, open-label, controlled study designed to investigate the effect of short-term neonatal skin barrier protection using a commercially available moisturiser on the prevention of atopic dermatitis and food allergy in high risk children.
Detailed description
Eczema, also known medically as Atopic Dermatitis (AD) is the most common skin disease of childhood, affecting 20% of Irish children, and is a general term for a group of skin conditions that cause the skin to become dry, red, itchy and inflamed. AD is often the first manifestation of atopic comorbidities including food allergy, asthma and allergic rhinitis. Recently published studies suggest that skin barrier preservation, with topically applied moisturisers in the first year of life, reduces the incidence of AD. Our own data suggests that an earlier window for this skin barrier protection may exist.
This study is a randomised, open-label, controlled study and will investigate the effect of short-term neonatal skin barrier protection on the prevention of AD and food allergy in high risk infants. Infants with at least one parent with a positive history of atopic disease (AD, allergic rhinitis, asthma or food allergy) will be eligible for recruitment.
The first study visit will take place within approximately 4 days of birth in the postnatal wards. At this visit, infants will be randomised to either treatment with skin barrier protection using a commercially available moisturiser or to standard routine skincare with no moisturiser from as soon as possible after birth until 2 months of age. This visit will also involve measurements of neonatal trans-epidermal water loss (TEWL) and natural moisturising factor (NMF) to assess skin barrier function and structure. Skin swabs will also be taken for microbiome and immune biomarker analysis.
Follow-up assessments will take place at 2, 4 and 8 weeks, 6 and 12 months. Each visit will include a physical examination of the infant's skin, including TEWL and NMF measurements, and a questionnaire on infant health, bathing and skincare.
Infant skin swabs will be taken again at 8 weeks and 12 months. A research nurse or doctor, blind to treatment allocation, will administer standardised assessments for the presence (yes/no), extent and severity of AD at 6 and 12 months. Suspected cases of food allergy will be investigated using skin prick testing (SPT) and oral food challenges.
A DNA sample will be taken to test for filaggrin loss-of-function mutations, which are linked to AD risk.
The primary outcome is AD at 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-centre, randomised, open-label, controlled study to evaluate whether short-term skin barrier protection using a moisturizer from birth to 2 months can prevent the onset of atopic dermatitis and food allergy at 12 months. Assessments of atopic dermatitis will be blinded.
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Other: Skin barrier protection in the first 2 months of lifeSkin barrier protection in the first 2 months of life. |
| Control arm | No intervention | –Standard skincare advice. No moisturiser in the first 2 months. |
Who may qualify
- Ages
- 0 to 5 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy full-term infants, gestational age >36+6 weeks.
- Infant has at least one parent with self-reported atopic dermatitis, food allergy, allergic rhinitis or asthma.
- Not requiring admission to the Neonatal Unit.
Key exclusion criteria (8 listed)
- No parental history of atopic disease.
- Admission to the Neonatal Unit for issues other than the establishment of normal feeding.
- Being administered oral or parenteral antibiotics.
- Receiving phototherapy for hyperbilirubinaemia.
- Sibling, including twin, already recruited.
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 |
|---|---|---|
| Skin barrier protection in the first 2 months of lifeSkin barrier protection in the first 2 months of life using a commercially available moisturiser from birth 2 months. Twice daily, whole-body application. | Other | Interventional arm |
Primary outcome
Cumulative incidence of atopic dermatitis at 12 months.
Time frame: 12 months
Cumulative incidence of IgE-mediated food allergy at 2 years
Time frame: 2 years
8 secondary outcomes
Longitudinal changes in transepidermal water loss (TEWL) from birth to 12 months
Time frame: Birth to 12 months
Longitudinal changes in natural moisturising factor (NMF) in the stratum corneum from birth to 12 months.
Time frame: Birth to 12 months
Microbial diversity and richness of the cheek and antecubital fossa (study subset).
Time frame: Skin swabs for microbiome analysis will be taken at baseline (0-4 days), 8 weeks and 12 months.
Changes in skin microbial diversity and richness over the first year of life.
Time frame: Skin swabs for microbiome analysis will be taken at baseline (0-4 days), 8 weeks and 12 months.
Comparison of microbial diversity and richness between the intervention and control groups.
Time frame: Skin swabs for microbiome analysis will be taken at baseline (0-4 days), 8 weeks and 12 months.
Skin biomarker profile analysis of the cheek and antecubital fossa (study subset).
Time frame: Skin swabs for biomarker analysis will be taken at baseline (0-4 days), 8 weeks and 12 months.
Changes in skin biomarker profile between study over the first year of life.
Time frame: Skin swabs for biomarker analysis will be taken at baseline (0-4 days), 8 weeks and 12 months.
Comparison of skin biomarker profiles between the intervention and control groups.
Time frame: Skin swabs for biomarker analysis will be taken at baseline (0-4 days), 8 weeks and 12 months.
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 22 Jun 2022.
- Derived from this study: PubMed 39826898Puppels GJ, Hourihane JO, Nico C, Chaoimh CN, Wong C, Common JE, Caspers PJ, Irvine AD. Highly accurate, noninvasive early identification of infants with a filaggrin loss-of-function mutation by in vivo Raman spectroscopy, followed from birth to 12 months. Ann Allergy Asthma Immunol. 2025 Apr;134(4):457-464. doi: 10.1016/j.anai.2025.01.010. Epub 2025 Jan 16.
- Derived from this study: PubMed 38460678Stamatas GN, Sato T, Chaoimh CN, Oddos T, Insel R, Hourihane JO, Irvine AD. Early skin inflammatory biomarker is predictive of development and persistence of atopic dermatitis in infants. J Allergy Clin Immunol. 2024 Jun;153(6):1597-1603.e4. doi: 10.1016/j.jaci.2024.02.018. Epub 2024 Mar 7.
- Individual participant dataSharing planned: Undecided
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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.
Jonathan O'B Hourihane, MD principal investigator
Royal College of Surgeons in Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin barrier protection in the first 2 months of life in people with Eczema Atopic Dermatitis and Eczema, run by University College Cork at 1 site in Ireland.
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 3 inclusion and 8 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 22 Jun 2022. 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 Ireland. 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?
Cumulative incidence of atopic dermatitis at 12 months. (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT03871998, which also lists 2 linked publications.
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 22 Jun 2022.