xml: <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/NCT05971355</url>
    </required_header>
    <id_info>
      <org_study_id>LAD-09-20</org_study_id>
      <nct_id>NCT05971355</nct_id>
    </id_info>
    <brief_title>Comparison of LimpiAD Cream 2.5% Plus Versus Vehicle and an Emollient in Patients With Atopic Dermatitis</brief_title>
    <official_title>Clinical Comparison of LimpiAD Cream 2.5% Plus, Vehicle and an Emollient in Pediatric Patients With Atopic Dermatitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Aileens Pharma SRL</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Aileens Pharma SRL</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this randomized clinical trial is to assess the efficacy and tolerability of&#xD;
        LimpiAD, a medical device in the form of a 2.5% Plus cream, as compared to the Vehicle of&#xD;
        LimpiAD 2.5% Plus cream and a standard emollient used as neutral control, which represents&#xD;
        the basic standard treatment (basic therapy) of AD according to European Guidelines in&#xD;
        pediatric subjects with mild to moderate Atopic Dermatitis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this clinical trial is to assess the efficacy and tolerability of LimpiAD, a&#xD;
        medical device in the form of a 2.5% Plus cream, as compared to the Vehicle of LimpiAD 2.5%&#xD;
        Plus cream and a standard emollient used as neutral control, which represents the basic&#xD;
        standard treatment (basic therapy) of AD according to European Guidelines in pediatric&#xD;
        subjects with mild to moderate Atopic Dermatitis.&#xD;
  &#xD;
        This is a randomized, double-blind, multicenter, stratified, clinical trial of the medical&#xD;
        device LimpiAD 2.5% Plus cream versus the vehicle of this medical device and versus an&#xD;
        emollient in pedriatic Atopic Dermatitis patients that will be randomized in a 2:2:1 fashion&#xD;
        to the compound mentioned above.&#xD;
  &#xD;
        The study aims to enrol two hundred (200) pediatric subjects of both sexes, with an age&#xD;
        ranging between 2 years old and 16 years old with atopic dermatitis of which at least 50 with&#xD;
        mild severity (EASI 1.0-7.0 and IGA = 2) and 50 cases with moderate severity (EASI 7.1-21.0&#xD;
        and IGA = 3).&#xD;
  &#xD;
        The treatment with the study product or with the control products shall be performed twice&#xD;
        daily (morning and evening) after cleansing, for 4 weeks.&#xD;
  &#xD;
        Clinical assessments shall be performed at baseline (T0) and after 2 and 4 weeks (T2 and T4)&#xD;
        by means of a daily reminder diary.&#xD;
  &#xD;
        The primary endpoint is the EASI improvement. The improvement shall be calculated by&#xD;
        comparing the baseline value (T0) with the corresponding value at week 4 (T4) for LimpiAD&#xD;
        2.5% Plus cream versus the vehicle of LimpiAD 2.5% Plus cream and versus the emollient, in&#xD;
        terms of detected score reduction (total EASI score).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 10, 2021</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>N/A</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>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Eczema Area and Severity Index (EASI)</measure>
      <time_frame>Baseline (T0), 2 weeks (T2) and 4 weeks (T4)</time_frame>
      <description>The change shall be calculated by comparing the baseline value (T0) with the corresponding value at 4 weeks (T4) for LimpiAD cream 2,5% Plus versus the Vehicle of LimpiAD cream 2,5% Plus in terms of detected score reduction (total EASI score).&#xD;
  INTERPRET EASI: Clear 0; Almost clear 0.1-1.0 ; Mild 1.1-7.0 ; Moderate 7.1-21.0 ; Severe 21.1-50.0; Very severe 50.1-72.0</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Investigator Global Assessment (IGA) scale for Atopic Dermatitis</measure>
      <time_frame>Baseline (T0), 2 weeks (T2) and 4 weeks (T4)</time_frame>
      <description>The change shall be calculated by comparing the baseline value (T0) with the corresponding values at 2 weeks (T2) and 4 weeks (T4) in the treatment arm with LimpiAD cream 2.5% Plus as compared to the other 2 study treatment arms.&#xD;
  INTERPRET IGA: 0 - Not affected; 1 - Little affected; 2 - Mild erythema; 3 - Moderate erythema; 4 - Severe Marked erythema</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Eczema Area and Severity Index (EASI) Change</measure>
      <time_frame>Baseline (T0), 2 weeks (T2) and 4 weeks (T4)</time_frame>
      <description>The change shall be calculated, by comparing the baseline value (T0) with the corresponding values at 2 weeks (T2) and 4 weeks (T4) in the treatment arm with LimpiAD cream 2.5% Plus as compared to the other 2 study treatment arms in terms of:&#xD;
  - % of patients reaching a 50% (EASI50), 75% (EASI75), 90% (EASI90) and 100% (EASI100) reduction in the baseline score.&#xD;
  INTERPRET EASI: Clear 0; Almost clear 0.1-1.0 ; Mild 1.1-7.0 ; Moderate 7.1-21.0 ; Severe 21.1-50.0; Very severe 50.1-72.0</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in pruritus at the 4 week (T4)</measure>
      <time_frame>Baseline (T0), 2 weeks (T2) and 4 weeks (T4)</time_frame>
      <description>Change in pruritus at the 4th week (T4): by improvement we mean a Visual Analogue Scale (VAS) reduction below 4 cm, with at least 2-score deviation from baseline (T0), including only the cases with VAS &gt; 5 at baseline, in the treatment arm with LimpiAD cream 2.5% Plus as compared to the other 2 study treatment arms.&#xD;
  In the visual analogue scale (VAS), patients are asked to mark on a 10-cm ruler ranging from 0 (no itch) to 10 (worst imaginable itch).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in sleep at 4 weeks (T4)</measure>
      <time_frame>Baseline (T0), 2 weeks (T2) and 4 weeks (T4)</time_frame>
      <description>Change in sleep at 4 weeks (T4) intended as mean a Visual Analogue Scale (VAS) reduction below 4 cm, with at least 2-score deviation from baseline (T0), including only the cases with VAS &gt;5 cm at baseline, in the treatment arm with LimpiAD cream 2.5% Plus as compared to the other 2 study treatment arms.&#xD;
  In the visual analogue scale (VAS), patients are asked to mark on a 10-cm ruler ranging from 0 (no disturbance sleep) to 10 (very much disturbed sleep).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in extension and signs intensity of the target areas</measure>
      <time_frame>Baseline (T0), 2 weeks (T2) and 4 weeks (T4)</time_frame>
      <description>Change in extension and signs intensity of the target areas, assessed as local Eczema Area and Severity Index (EASI), by separately considering the skin fold area with respect to the fold-free skin area at 2 weeks (T2) and 4 weeks (T4) in the treatment arm with LimpiAD cream 2.5% Plus as compared to the other 2 study treatment arms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Children's Dermatology Life Quality Index (CDLQI) questionnaire</measure>
      <time_frame>Baseline (T0), 2 weeks (T2) and 4 weeks (T4)</time_frame>
      <description>Change in Children's Dermatology Life Quality Index (CDLQI). The change shall be calculated, by comparing the baseline total points (T0) with the corresponding total points at 2 weeks (T2) and 4 weeks (T4) in the treatment arm with LimpiAD cream 2.5% Plus as compared to the other 2 study treatment arms in terms of:&#xD;
  % of achievement of CDLQI &lt;10&#xD;
  CDLQI average score reduction&#xD;
  The CDLQI has 11 questions asking about the impact of a atopic dermatitis on the life of the affected child over the last week.&#xD;
  Interpretation of QoL: 0-2 = no effect on QoL, 3-7 small effect, 8-13 moderate effect, 14-19 very large effect, 20-33 extremely large effect</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Microbial balance</measure>
      <time_frame>Baseline (T0), 2 weeks (T2) and 4 weeks (T4)</time_frame>
      <description>Change in Cutibacterium acne/Staphylococcus ratio on the affected skin in the treatment arm with LimpiAD cream 2.5% Plus as compared to the other 2 study treatment arms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional recovery</measure>
      <time_frame>Baseline (T0), 2 weeks (T2) and 4 weeks (T4)</time_frame>
      <description>Functional recovery:&#xD;
  - change in vascularization measured by dynamic OCT (D-OCT) imaging, assessed in a subsample of subjects, in the treatment arm with LimpiAD 2.5% cream Plus as compared to the other 2 study treatment arms.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Atopic Dermatitis</condition>
    <arm_group>
      <arm_group_label>Treatment group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>LimpiAD cream 2,5% plus to be applied twice a day (morning and evening) for 4 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Vehicle of LimpiAD cream 2,5% plus to be applied twice a day (morning and evening) for 4 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Emollient group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Emollient cream to be applied twice a day (morning and evening) for 4 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>LimpiAD cream 2,5% plus</intervention_name>
      <description>A topical formulation that contains Hyaluronic Acid conjugated with a bacterial wall fragment of Cutibacterium species (HAc-40) and an emollient base. LimpiAD exerts its post-biotic action through the seizure/ trapping and inactivation of catabolites and / or toxins produced by S. aureus as well as protecting the hydrolipidic film, especially in case of dryness, itching, and, in conditions of altered microbiome</description>
      <arm_group_label>Treatment group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Vehicle</intervention_name>
      <description>Vehicle of LimpiAD cream 2.5 % plus which has the qualities of an emollient technically enriched with active ingredients known for their use in AD (&quot;plus&quot; emollient) - having the same ingredients of LimpiAD 2.5% Plus cream but without the HAc-40 component.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Emollient</intervention_name>
      <description>Standard emollient used as neutral control, having only a moisturizing and skin barrier action, which represents the basic standard treatment (basic therapy) of atopic dermatitis according to the European Guidelines.</description>
      <arm_group_label>Emollient group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria&#xD;
  &#xD;
          Subjects of both sexes, with age ranging between 2 years and 16 years, Caucasian and in&#xD;
          good health, whose parents/tutors provided a written and signed informed consent for their&#xD;
          participation in the study shall be enrolled. In particular, as regards parents/tutors:&#xD;
  &#xD;
            -  both parents/tutors, in case of joint custody, should provide a written and signed&#xD;
               informed consent for the participation of the child in the study, according to the&#xD;
               instructions provided by the Investigators.&#xD;
  &#xD;
            -  they should accept to bring the child to the clinical trial facility on predefined&#xD;
               visit days, according to the instructions provided by the Investigators;&#xD;
  &#xD;
            -  they should be willing and able to follow the trial requirements provided by the&#xD;
               Investigators.&#xD;
  &#xD;
          Inclusion criteria provide that:&#xD;
  &#xD;
            -  Symptoms and signs compatible with a clinical diagnosis of Atopic Dermatitis should be&#xD;
               present upon enrollment;&#xD;
  &#xD;
            -  The clinical severity of AD should correspond to an EASI ranging between 1.0 and 21.0&#xD;
               and an IGA equal to 2 or 3;&#xD;
  &#xD;
            -  Pruritus severity assessed by means of VAS scale ≥ 4 cm) should be referred to the&#xD;
               part of the body to be treated, as a requirement for inclusion in the study;&#xD;
  &#xD;
            -  The clinical assessment should envisage for the patient the indication of a&#xD;
               moisturizing/emollient treatment as single therapy for AD (in accordance with European&#xD;
               Guidelines on AD treatment).&#xD;
  &#xD;
          Exclusion Criteria&#xD;
  &#xD;
          The following items are to be considered as exclusion criteria:&#xD;
  &#xD;
            -  the application of cortisone-based products on the skin to be treated in the 2 weeks&#xD;
               prior to treatment;&#xD;
  &#xD;
            -  use of antibiotics and systemic anti-inflammatory drugs for AD in the 2 weeks&#xD;
               preceding treatment and during the study (paracetamol is allowed at dosages and&#xD;
               indications recommended for use as an antipyretic and analgesic);&#xD;
  &#xD;
            -  ongoing baseline treatment (T0) with anti-inflammatory drugs, antihistamines,&#xD;
               antitussives and/or inhaled steroids in the 2 previous weeks, retinoids and/or&#xD;
               immunosuppressants in the previous 6 months.&#xD;
  &#xD;
            -  use of systemic steroids in the 4 weeks prior to the study.&#xD;
  &#xD;
            -  Intense and prolonged sun exposure in the 30 days preceding the screening.&#xD;
  &#xD;
            -  severe AD (EASI &gt; 21) or mild/moderate AD requiring a local and/or systemic treatment&#xD;
               included among treatments not allowed, as provided for in exclusion criteria;&#xD;
  &#xD;
            -  hypersensitivity to the study products.&#xD;
  &#xD;
            -  acute or chronic skin diseases - except for atopic eczema - which may invalidate&#xD;
               clinical assessments or overlap with AD skin picture;&#xD;
  &#xD;
            -  systemic diseases which may affect the subject's safety or wellbeing or interfere with&#xD;
               skin response.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>2 Years</minimum_age>
      <maximum_age>16 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Francesca Farnetani, Prof</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Modena e Reggio Emilia</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marco Alfio Cutuli, M.Sc.</last_name>
      <phone>+393899407083</phone>
      <email>marco.cutuli@aileenspharma.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sonia Longo Sormani, M.Sc.</last_name>
      <phone>+393486556591</phone>
      <email>sonia.longo@aileenspharma.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Bari Hospital</name>
        <address>
          <city>Bari</city>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Domenico Bonamonte, Prof</last_name>
        <email>domenico.bonamonte@uniba.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>University of Modena e Reggio Emilia</name>
        <address>
          <city>Modena</city>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Francesca Farnetani, Prof</last_name>
        <email>francesca.farnetani@unimore.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>University of Naples Hospital</name>
        <address>
          <city>Naples</city>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Giuseppe Argenziano, Prof</last_name>
        <email>g.argenziano@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>S. Gallicano Hospital</name>
        <address>
          <city>Rome</city>
          <country>Italy</country>
        </address>
      </facility>
      <status>Terminated</status>
    </location>
    <location>
      <facility>
        <name>University Rome La Sapienza (Hospital Umberto I)</name>
        <address>
          <city>Rome</city>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Giovanni Pellacani, Prof</last_name>
        <email>pellacani.giovanni@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>April 27, 2021</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Atopic dermatitis</keyword>
    <keyword>topical treatment</keyword>
    <keyword>pediatric atopic dermatitis</keyword>
    <keyword>atopic eczema</keyword>
    <keyword>LimpiAD</keyword>
    <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>Emollients</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05971355
  org study id: LAD-09-20
  nct id: NCT05971355
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this randomized clinical trial is to assess the efficacy and tolerability of
        LimpiAD, a medical device in the form of a 2.5% Plus cream, as compared to the Vehicle of
        LimpiAD 2.5% Plus cream and a standard emollient used as neutral control, which represents
        the basic standard treatment (basic therapy) of AD according to European Guidelines in
        pediatric subjects with mild to moderate Atopic Dermatitis.
  The purpose of this clinical trial is to assess the efficacy and tolerability of LimpiAD, a
        medical device in the form of a 2.5% Plus cream, as compared to the Vehicle of LimpiAD 2.5%
        Plus cream and a standard emollient used as neutral control, which represents the basic
        standard treatment (basic therapy) of AD according to European Guidelines in pediatric
        subjects with mild to moderate Atopic Dermatitis.
  
        This is a randomized, double-blind, multicenter, stratified, clinical trial of the medical
        device LimpiAD 2.5% Plus cream versus the vehicle of this medical device and versus an
        emollient in pedriatic Atopic Dermatitis patients that will be randomized in a 2:2:1 fashion
        to the compound mentioned above.
  
        The study aims to enrol two hundred (200) pediatric subjects of both sexes, with an age
        ranging between 2 years old and 16 years old with atopic dermatitis of which at least 50 with
        mild severity (EASI 1.0-7.0 and IGA = 2) and 50 cases with moderate severity (EASI 7.1-21.0
        and IGA = 3).
  
        The treatment with the study product or with the control products shall be performed twice
        daily (morning and evening) after cleansing, for 4 weeks.
  
        Clinical assessments shall be performed at baseline (T0) and after 2 and 4 weeks (T2 and T4)
        by means of a daily reminder diary.
  
        The primary endpoint is the EASI improvement. The improvement shall be calculated by
        comparing the baseline value (T0) with the corresponding value at week 4 (T4) for LimpiAD
        2.5% Plus cream versus the vehicle of LimpiAD 2.5% Plus cream and versus the emollient, in
        terms of detected score reduction (total EASI score).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Change in Eczema Area and Severity Index (EASI)
  time frame: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
  description: The change shall be calculated by comparing the baseline value (T0) with the corresponding value at 4 weeks (T4) for LimpiAD cream 2,5% Plus versus the Vehicle of LimpiAD cream 2,5% Plus in terms of detected score reduction (total EASI score).
  INTERPRET EASI: Clear 0; Almost clear 0.1-1.0 ; Mild 1.1-7.0 ; Moderate 7.1-21.0 ; Severe 21.1-50.0; Very severe 50.1-72.0
  measure: Change in Investigator Global Assessment (IGA) scale for Atopic Dermatitis
  time frame: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
  description: The change shall be calculated by comparing the baseline value (T0) with the corresponding values at 2 weeks (T2) and 4 weeks (T4) in the treatment arm with LimpiAD cream 2.5% Plus as compared to the other 2 study treatment arms.
  INTERPRET IGA: 0 - Not affected; 1 - Little affected; 2 - Mild erythema; 3 - Moderate erythema; 4 - Severe Marked erythema
  measure: Eczema Area and Severity Index (EASI) Change
  time frame: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
  description: The change shall be calculated, by comparing the baseline value (T0) with the corresponding values at 2 weeks (T2) and 4 weeks (T4) in the treatment arm with LimpiAD cream 2.5% Plus as compared to the other 2 study treatment arms in terms of:
  - % of patients reaching a 50% (EASI50), 75% (EASI75), 90% (EASI90) and 100% (EASI100) reduction in the baseline score.
  INTERPRET EASI: Clear 0; Almost clear 0.1-1.0 ; Mild 1.1-7.0 ; Moderate 7.1-21.0 ; Severe 21.1-50.0; Very severe 50.1-72.0
  measure: Change in pruritus at the 4 week (T4)
  time frame: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
  description: Change in pruritus at the 4th week (T4): by improvement we mean a Visual Analogue Scale (VAS) reduction below 4 cm, with at least 2-score deviation from baseline (T0), including only the cases with VAS > 5 at baseline, in the treatment arm with LimpiAD cream 2.5% Plus as compared to the other 2 study treatment arms.
  In the visual analogue scale (VAS), patients are asked to mark on a 10-cm ruler ranging from 0 (no itch) to 10 (worst imaginable itch).
  measure: Change in sleep at 4 weeks (T4)
  time frame: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
  description: Change in sleep at 4 weeks (T4) intended as mean a Visual Analogue Scale (VAS) reduction below 4 cm, with at least 2-score deviation from baseline (T0), including only the cases with VAS >5 cm at baseline, in the treatment arm with LimpiAD cream 2.5% Plus as compared to the other 2 study treatment arms.
  In the visual analogue scale (VAS), patients are asked to mark on a 10-cm ruler ranging from 0 (no disturbance sleep) to 10 (very much disturbed sleep).
  measure: Change in extension and signs intensity of the target areas
  time frame: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
  description: Change in extension and signs intensity of the target areas, assessed as local Eczema Area and Severity Index (EASI), by separately considering the skin fold area with respect to the fold-free skin area at 2 weeks (T2) and 4 weeks (T4) in the treatment arm with LimpiAD cream 2.5% Plus as compared to the other 2 study treatment arms
  measure: Children's Dermatology Life Quality Index (CDLQI) questionnaire
  time frame: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
  description: Change in Children's Dermatology Life Quality Index (CDLQI). The change shall be calculated, by comparing the baseline total points (T0) with the corresponding total points at 2 weeks (T2) and 4 weeks (T4) in the treatment arm with LimpiAD cream 2.5% Plus as compared to the other 2 study treatment arms in terms of:
  % of achievement of CDLQI <10
  CDLQI average score reduction
  The CDLQI has 11 questions asking about the impact of a atopic dermatitis on the life of the affected child over the last week.
  Interpretation of QoL: 0-2 = no effect on QoL, 3-7 small effect, 8-13 moderate effect, 14-19 very large effect, 20-33 extremely large effect
  measure: Microbial balance
  time frame: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
  description: Change in Cutibacterium acne/Staphylococcus ratio on the affected skin in the treatment arm with LimpiAD cream 2.5% Plus as compared to the other 2 study treatment arms.
  measure: Functional recovery
  time frame: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
  description: Functional recovery:
  - change in vascularization measured by dynamic OCT (D-OCT) imaging, assessed in a subsample of subjects, in the treatment arm with LimpiAD 2.5% cream Plus as compared to the other 2 study treatment arms.
  arm group label: Treatment group
  arm group type: Experimental
  description: LimpiAD cream 2,5% plus to be applied twice a day (morning and evening) for 4 weeks.
  arm group label: Control group
  arm group type: Active Comparator
  description: Vehicle of LimpiAD cream 2,5% plus to be applied twice a day (morning and evening) for 4 weeks.
  arm group label: Emollient group
  arm group type: Active Comparator
  description: Emollient cream to be applied twice a day (morning and evening) for 4 weeks.
  intervention type: Device
  intervention name: LimpiAD cream 2,5% plus
  description: A topical formulation that contains Hyaluronic Acid conjugated with a bacterial wall fragment of Cutibacterium species (HAc-40) and an emollient base. LimpiAD exerts its post-biotic action through the seizure/ trapping and inactivation of catabolites and / or toxins produced by S. aureus as well as protecting the hydrolipidic film, especially in case of dryness, itching, and, in conditions of altered microbiome
  arm group label: Treatment group
  intervention type: Other
  intervention name: Vehicle
  description: Vehicle of LimpiAD cream 2.5 % plus which has the qualities of an emollient technically enriched with active ingredients known for their use in AD ("plus" emollient) - having the same ingredients of LimpiAD 2.5% Plus cream but without the HAc-40 component.
  arm group label: Control group
  intervention type: Other
  intervention name: Emollient
  description: Standard emollient used as neutral control, having only a moisturizing and skin barrier action, which represents the basic standard treatment (basic therapy) of atopic dermatitis according to the European Guidelines.
  arm group label: Emollient group
  criteria: 
  gender: All
  minimum age: 2 Years
  maximum age: 16 Years
  healthy volunteers: No
  last name: Francesca Farnetani, Prof
  role: Principal Investigator
  affiliation: University of Modena e Reggio Emilia
  last name: Marco Alfio Cutuli, M.Sc.
  phone: +393899407083
  email: marco.cutuli@aileenspharma.com
  last name: Sonia Longo Sormani, M.Sc.
  phone: +393486556591
  email: sonia.longo@aileenspharma.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Terminated
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Dermatitis, Atopic
  mesh term: Dermatitis
  mesh term: Eczema
  mesh term: Emollients
  sharing ipd: No