<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/NCT04468711</url>
  </required_header>
  <id_info>
    <org_study_id>12-2018</org_study_id>
    <nct_id>NCT04468711</nct_id>
  </id_info>
  <brief_title>Vitamin D in Egyptian Children With Atopic Dermatitis</brief_title>
  <official_title>The Impact of Vitamin D Supplementation as an Adjuvant Therapy on Clinical Outcome in Patients With Severe Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Hepatology &amp; Tropical Medicine Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Hepatology &amp; Tropical Medicine Research Institute</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>
      There is an emergent evidence demonstrating the role of Vitamin D deficiency in eczema.&#xD;
      Vitamin D supplementation with standard treatment yielded positive clinical outcomes for&#xD;
      children and adolescents with mild and moderate AD; however, the potential benefit of vitamin&#xD;
      D in severe cases remains unclear&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 6, 2018</start_date>
  <completion_date type="Actual">June 4, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2018</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>difference in the mean Eczema Area and Severity Index (EASI) score at the end of the study</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>the average percent change in Eczema Area and Severity Index (EASI) score at the end of the study</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in proportion of patients with a reduction from baseline of 75 % in Eczema Area and Severity Index (EASI) score</measure>
    <time_frame>12 weeks</time_frame>
    <description>EASI 75</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in proportion of patients with a reduction from baseline of (50 or more up to 75) in Eczema Area and Severity Index (EASI) score</measure>
    <time_frame>12 weeks</time_frame>
    <description>EASI 50</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in proportion of patients with a reduction from baseline of &lt;50 n Eczema Area and Severity Index (EASI) score</measure>
    <time_frame>12 weeks</time_frame>
    <description>EASI&lt;50</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">92</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>treatment group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>vitamin D plus topical 1% hydrocortisone cream twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo plus plus topical 1% hydrocortisone cream twice daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin D</intervention_name>
    <description>Vitamin D plus topical 1% hydrocortisone cream twice daily</description>
    <arm_group_label>treatment group</arm_group_label>
    <other_name>plus topical 1% hydrocortisone cream twice daily</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>placebo plus topical 1% hydrocortisone cream twice daily</description>
    <arm_group_label>placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1.diagnosis of severe AD according to Hanifin and Rajka criteria and the Eczema Area and&#xD;
        Severity Index (EASI) score&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. serious skin disorder other than AD.&#xD;
&#xD;
          2. taking systemic corticosteroids or anti-inflammatory medications, prior vitamin D&#xD;
             supplementation&#xD;
&#xD;
          3. receiving oral or topical antibiotics or topical calcineurin inhibitors for at least&#xD;
             one week prior to enrollment&#xD;
&#xD;
          4. known gut absorption problem, presence of active skin infection at baseline any known&#xD;
             hepatic and/or renal disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>NHTRMI</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 10, 2020</last_update_submitted>
  <last_update_submitted_qc>July 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Hepatology &amp; Tropical Medicine Research Institute</investigator_affiliation>
    <investigator_full_name>Noha Mansour</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </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>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Hydrocortisone</mesh_term>
  </intervention_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/NCT04468711
org study id: 12-2018
nct id: NCT04468711
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
There is an emergent evidence demonstrating the role of Vitamin D deficiency in eczema.
      Vitamin D supplementation with standard treatment yielded positive clinical outcomes for
      children and adolescents with mild and moderate AD; however, the potential benefit of vitamin
      D in severe cases remains unclear
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: difference in the mean Eczema Area and Severity Index (EASI) score at the end of the study
time frame: 12 weeks
measure: the average percent change in Eczema Area and Severity Index (EASI) score at the end of the study
time frame: 12 weeks
measure: Difference in proportion of patients with a reduction from baseline of 75 % in Eczema Area and Severity Index (EASI) score
time frame: 12 weeks
description: EASI 75
measure: Difference in proportion of patients with a reduction from baseline of (50 or more up to 75) in Eczema Area and Severity Index (EASI) score
time frame: 12 weeks
description: EASI 50
measure: Difference in proportion of patients with a reduction from baseline of <50 n Eczema Area and Severity Index (EASI) score
time frame: 12 weeks
description: EASI<50
arm group label: treatment group
arm group type: Active Comparator
description: vitamin D plus topical 1% hydrocortisone cream twice daily
arm group label: placebo group
arm group type: Placebo Comparator
description: placebo plus plus topical 1% hydrocortisone cream twice daily
intervention type: Drug
intervention name: Vitamin D
description: Vitamin D plus topical 1% hydrocortisone cream twice daily
arm group label: treatment group
other name: plus topical 1% hydrocortisone cream twice daily
intervention type: Drug
intervention name: Placebo
description: placebo plus topical 1% hydrocortisone cream twice daily
arm group label: placebo group
criteria: 
gender: All
minimum age: 5 Years
maximum age: 16 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: National Hepatology & Tropical Medicine Research Institute
investigator full name: Noha Mansour
investigator title: Principal Investigator
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
mesh term: Vitamin D
mesh term: Hydrocortisone
sharing ipd: No