Dermatitis, AtopicPhase 2ACE-ADNCT03808532
Moisturizer to Prevent Atopic Dermatitis
A Phase 2 study testing Cura+ Moisturizing Cream in people with Dermatitis, Atopic, run by MYOR Ltd..
Trial summary
Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disorder associated with a decreased ability of the skin to function as an efficient immunological barrier. The disease is now two to three times more prevalent in children than it was just four decades ago. Read more about this study
- Who is it for?
- Ages 24 to 120 hoursHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Cura+ Moisturizing Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2020to Dec 2022
- Phase
- Phase 2
- 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
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
- Average forearm TEWL reading of >8.50 g/m2
- 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 (birth prior to 37 weeks gestation)
- 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 conditions which precludes the daily application of moisturizing lotion
- Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety
About this study
Official title: A Prospective Randomized Open-label Controlled Study to Assess Whether Daily Application of Skin Moisturizer Containing Acemannan Hydrogel From Birth Can Prevent Atopic Dermatitis in Children
Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disorder associated with a decreased ability of the skin to function as an efficient immunological barrier. The disease is now two to three times more prevalent in children than it was just four decades ago. It is manifested by eczematous skin lesions associated with severe itch, leading to a significant impairment in quality of life. Of additional importance, AD oftentimes progresses to allergic rhinitis and/or asthma, a process referred to as the "atopic march." Recent reports have indicated that daily application of moisturizing creams on neonates and infants can prevent the occurrence of AD and subsequently food allergies. This is postulated to be the outcome of restoring the barrier integrity of the skin through the daily application of moisturizer.
- Conditions
- Dermatitis, Atopic
- Being tested
- Cura+ Moisturizing Cream
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cura+ Moisturizing CreamOther
Parents of at-risk infants in the intervention arm will be instructed to apply moisturizer to the infant's entire body once daily for six months.
| Study group | Role | What they receive |
|---|---|---|
| High-Risk with Moisturizer | Experimental | Not described Receives: Other: Cura+ Moisturizing Cream |
| High-Risk without Moisturizer | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of AD at twelve months of age in the intervention group compared to the control
Evaluated using the UK refinement of the Hanifin and Rajka diagnostic criteria for atopic eczema and by parental report of a medical diagnosis of AD by the infant's pediatrician and/or dermatologist
Measured: 12 months
Secondary outcomes (6)
Cumulative incidence of AD at six months of age in the intervention group compared to the control
Evaluated using the UK refinement of the Hanifin and Rajka diagnostic criteria for atopic eczema and by parental report of a medical diagnosis of AD by the infant's pediatrician and/or dermatologist
Measured: 6 months
Cumulative incidence of AD at 24 months of age in the intervention group compared to the control
Evaluated using the UK refinement of the Hanifin and Rajka diagnostic criteria for atopic eczema and by parental report of a medical diagnosis of AD by the infant's pediatrician and/or dermatologist
Measured: 24 months
Timing of onset of AD in the intervention group compared to the control
Evaluated using the UK refinement of the Hanifin and Rajka diagnostic criteria for atopic eczema and by parental report of a medical diagnosis of AD by the infant's pediatrician and/or dermatologist
Measured: 12 months
Severity of AD in the intervention group compared to the control
Assessed using the Patient-Oriented Eczema Measure (POEM) questionnaire and accompanying scoring criteria. Additionally, it will be assessed by parental report of first steroidal indication by physician.
Measured: 12 months
Cumulative incidence of food allergies at 12 months of age in the intervention group compared to the control
Evaluated with the 2010 U.S. Food and Drug Administration Food Safety Survey Questionnaire.
Measured: 12 months
Cumulative incidence of food allergies at 24 months of age in the intervention group compared to the control
Evaluated with the 2010 U.S. Food and Drug Administration Food Safety Survey Questionnaire.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study startJun 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MYOR Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Assuta Ashdod Hospital
- Responsible party
- Sponsor
- Investigators
- Elena Fridman, MD, Principal investigator, Assuta Ashdod Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808532
- Sponsor's protocol ID
- MYOR
- Acronym
- ACE-AD
- Status last verified
- Jan 2021
- First submitted
- 2 Jan 2019
- Last updated
- 15 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Open-label Controlled Study to Assess Whether Daily Application of Skin Moisturizer Containing Acemannan Hydrogel From Birth Can Prevent Atopic Dermatitis in Children
- ClinicalTrials.gov ID
- NCT03808532
- Acronym / sponsor ID
- ACE-AD / MYOR
- Conditions
- Dermatitis, Atopic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MYOR Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Assuta Ashdod Hospital
- Study start
- Jun 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 17 Jan 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.
Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disorder associated with a decreased ability of the skin to function as an efficient immunological barrier. The disease is now two to three times more prevalent in children than it was just four decades ago. It is manifested by eczematous skin lesions associated with severe itch, leading to a significant impairment in quality of life. Of additional importance, AD oftentimes progresses to allergic rhinitis and/or asthma, a process referred to as the "atopic march." Recent reports have indicated that daily application of moisturizing creams on neonates and infants can prevent the occurrence of AD and subsequently food allergies. This is postulated to be the outcome of restoring the barrier integrity of the skin through the daily application of moisturizer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Risk with Moisturizer | Experimental | Other: Cura+ Moisturizing Cream |
| High-Risk without Moisturizer | No intervention | – |
Who may qualify
- Ages
- 24 to 120 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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
- Average forearm TEWL reading of >8.50 g/m2
- 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 (birth prior to 37 weeks gestation)
- 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
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 |
|---|---|---|
| Cura+ Moisturizing CreamParents of at-risk infants in the intervention arm will be instructed to apply moisturizer to the infant's entire body once daily for six months. | Other | High-Risk with Moisturizer |
Primary outcome
Cumulative incidence of AD at twelve months of age in the intervention group compared to the control
Time frame: 12 months
Evaluated using the UK refinement of the Hanifin and Rajka diagnostic criteria for atopic eczema and by parental report of a medical diagnosis of AD by the infant's pediatrician and/or dermatologist
6 secondary outcomes
Cumulative incidence of AD at six months of age in the intervention group compared to the control
Time frame: 6 months
Cumulative incidence of AD at 24 months of age in the intervention group compared to the control
Time frame: 24 months
Timing of onset of AD in the intervention group compared to the control
Time frame: 12 months
Severity of AD in the intervention group compared to the control
Time frame: 12 months
Cumulative incidence of food allergies at 12 months of age in the intervention group compared to the control
Time frame: 12 months
Cumulative incidence of food allergies at 24 months of age in the intervention group compared to the control
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- 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.
Elena Fridman, MD principal investigator
Assuta Ashdod Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cura+ Moisturizing Cream in people with Dermatitis, Atopic, run by MYOR Ltd..
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: withdrawn, as of the sponsor's last update on 15 Jan 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 AD at twelve months of age in the intervention group compared to the control (time frame: 12 months). 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 15 Jan 2021.