<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03808532</url>
  </required_header>
  <id_info>
    <org_study_id>MYOR</org_study_id>
    <nct_id>NCT03808532</nct_id>
  </id_info>
  <brief_title>Moisturizer to Prevent Atopic Dermatitis</brief_title>
  <acronym>ACE-AD</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MYOR Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Assuta Ashdod Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>MYOR Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disorder associated with a&#xD;
      decreased ability of the skin to function as an efficient immunological barrier. The disease&#xD;
      is now two to three times more prevalent in children than it was just four decades ago. It is&#xD;
      manifested by eczematous skin lesions associated with severe itch, leading to a significant&#xD;
      impairment in quality of life. Of additional importance, AD oftentimes progresses to allergic&#xD;
      rhinitis and/or asthma, a process referred to as the &quot;atopic march.&quot; Recent reports have&#xD;
      indicated that daily application of moisturizing creams on neonates and infants can prevent&#xD;
      the occurrence of AD and subsequently food allergies. This is postulated to be the outcome of&#xD;
      restoring the barrier integrity of the skin through the daily application of moisturizer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lack of funding&#xD;
  </why_stopped>
  <start_date type="Anticipated">June 2020</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cumulative incidence of AD at twelve months of age in the intervention group compared to the control</measure>
    <time_frame>12 months</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of AD at six months of age in the intervention group compared to the control</measure>
    <time_frame>6 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of AD at 24 months of age in the intervention group compared to the control</measure>
    <time_frame>24 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timing of onset of AD in the intervention group compared to the control</measure>
    <time_frame>12 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of AD in the intervention group compared to the control</measure>
    <time_frame>12 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of food allergies at 12 months of age in the intervention group compared to the control</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluated with the 2010 U.S. Food and Drug Administration Food Safety Survey Questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of food allergies at 24 months of age in the intervention group compared to the control</measure>
    <time_frame>24 months</time_frame>
    <description>Evaluated with the 2010 U.S. Food and Drug Administration Food Safety Survey Questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Dermatitis, Atopic</condition>
  <arm_group>
    <arm_group_label>High-Risk with Moisturizer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>High-Risk without Moisturizer</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cura+ Moisturizing Cream</intervention_name>
    <description>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.</description>
    <arm_group_label>High-Risk with Moisturizer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. A healthy newborn delivered in a hospital setting more than 24 hours prior to&#xD;
             enrollment &amp; less than 120 hours prior to enrollment&#xD;
&#xD;
          2. Average forearm TEWL reading of &gt;8.50 g/m2&#xD;
&#xD;
          3. Mothers must be aged &gt;18 years&#xD;
&#xD;
          4. Parents' ability to complete questionnaire(s) at defined times throughout study&#xD;
             duration&#xD;
&#xD;
          5. Parents or legal guardian provide informed written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Preterm birth (birth prior to 37 weeks gestation)&#xD;
&#xD;
          2. Neonate has undergone major surgery or intends to undergo major surgery in the coming&#xD;
             14 days&#xD;
&#xD;
          3. Neonate has an existing widespread skin condition that would make the detection and/or&#xD;
             assessment of eczema difficult&#xD;
&#xD;
          4. Neonate has been administered oral or parenteral antibiotics from birth until study&#xD;
             enrollment&#xD;
&#xD;
          5. Neonate has a serious health issue which, at parent or investigator discretion, would&#xD;
             make it difficult for the neonate or parents to take part in the trial&#xD;
&#xD;
          6. Any conditions which precludes the daily application of moisturizing lotion&#xD;
&#xD;
          7. Any other reason that, in the opinion of the investigator, prevents the subject from&#xD;
             participating in the study or compromise the patient safety&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Hours</minimum_age>
    <maximum_age>120 Hours</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elena Fridman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assuta Ashdod Hospital</affiliation>
  </overall_official>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>January 13, 2021</last_update_submitted>
  <last_update_submitted_qc>January 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03808532
org study id: MYOR
nct id: NCT03808532
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Cumulative incidence of AD at twelve months of age in the intervention group compared to the control
time frame: 12 months
description: 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
measure: Cumulative incidence of AD at six months of age in the intervention group compared to the control
time frame: 6 months
description: 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
measure: Cumulative incidence of AD at 24 months of age in the intervention group compared to the control
time frame: 24 months
description: 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
measure: Timing of onset of AD in the intervention group compared to the control
time frame: 12 months
description: 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
measure: Severity of AD in the intervention group compared to the control
time frame: 12 months
description: 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.
measure: Cumulative incidence of food allergies at 12 months of age in the intervention group compared to the control
time frame: 12 months
description: Evaluated with the 2010 U.S. Food and Drug Administration Food Safety Survey Questionnaire.
measure: Cumulative incidence of food allergies at 24 months of age in the intervention group compared to the control
time frame: 24 months
description: Evaluated with the 2010 U.S. Food and Drug Administration Food Safety Survey Questionnaire.
arm group label: High-Risk with Moisturizer
arm group type: Experimental
arm group label: High-Risk without Moisturizer
arm group type: No Intervention
intervention type: Other
intervention name: Cura+ Moisturizing Cream
description: 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.
arm group label: High-Risk with Moisturizer
criteria: 
gender: All
minimum age: 24 Hours
maximum age: 120 Hours
healthy volunteers: Accepts Healthy Volunteers
last name: Elena Fridman, MD
role: Principal Investigator
affiliation: Assuta Ashdod Hospital
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
sharing ipd: No