<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/NCT03250624</url>
  </required_header>
  <id_info>
    <org_study_id>RD.03.SPR.109696</org_study_id>
    <nct_id>NCT03250624</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of CD5024 0.3% Cream in Subjects With Atopic Dermatitis</brief_title>
  <official_title>Safety and Efficacy of CD5024 0.3% Cream in Subjects With Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Galderma R&amp;D</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Galderma R&amp;D</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Exploratory, multi-centric, randomized, vehicle-controlled, investigator-blind, parallel&#xD;
      group study, involved participants with chronic lesions of Atopic Dermatitis (AD) to evaluate&#xD;
      the local and systemic safety of CD5024 0.3% cream over a 6-week treatment period compared to&#xD;
      its vehicle.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study application was performed once daily, 7 days a week for 6 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2016</start_date>
  <completion_date type="Actual">June 26, 2017</completion_date>
  <primary_completion_date type="Actual">June 26, 2017</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>Other</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Eczema Area and Severity Index (EASI) Score at Day 43</measure>
    <time_frame>Baseline, Day 43</time_frame>
    <description>The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum), with the higher scores indicated the worse severity of AD. All missing values were imputed by Last Observation Carried Forward (LOCF).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in EASI at Each Visit</measure>
    <time_frame>Baseline, Days 8,15, 22, 29, 36 and 43</time_frame>
    <description>The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores indicated the worse severity of AD. All missing values were imputed by LOCF.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear)</measure>
    <time_frame>Days 8, 15, 22, 29, 36 and 43</time_frame>
    <description>IGA scale consisted of 5 grades (0-4) among which 0 = Clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting), 1 = Almost clear (Trace, faint pink erythema with almost no induration/papulation and no oozing/crusting), 2 = Mild (Faint pink erythema with mild induration/papulation and no oozing/crusting), 3 = Moderate (Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting.), 4 = Severe (Deep/bright red erythema with severe induration/papulation with oozing/crusting). Success rate was defined as percentage of participants who achieved an IGA score of 1 (almost clear) or 0 (Clear) at specified visits. All missing values were imputed by LOCF.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Total Sum Score (TSS) at Each Visit</measure>
    <time_frame>Baseline, Days 8, 15, 22, 29, 36 and 43</time_frame>
    <description>The TSS was the sum of individual clinical severity scores for 5 signs of AD (erythema, induration/papulation, oozing/crusting, excoriation and lichenification). The severity of each sign was evaluated by using a 4-graded scale (0: none; 1: mild; 2: moderate; 3: severe). The total score ranges from 0 to 15, where higher score indicated worse severity of AD. All missing values were imputed by LOCF.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit</measure>
    <time_frame>Baseline, Days 8, 15, 22, 29, 36 and 43</time_frame>
    <description>SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with visual analog scale (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), &amp; subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. Higher scores indicated worse outcome. All missing values were imputed by LOCF.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit</measure>
    <time_frame>Baseline, Weeks 1, 2, 3, 4, 5 and 6</time_frame>
    <description>Pruritus NRS was a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 = 'no itch' and 10 = 'worst itch imaginable', where higher score indicated very severe itch. All missing values were imputed by LOCF.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pruritus Verbal Rating Scale (VRS) Score at Day 43</measure>
    <time_frame>Baseline, Day 43</time_frame>
    <description>Participants were asked for a response that best described their pruritus intensity in last 24 hours, to rate their itch using a list of adjectives describing different levels of symptom intensity rated on a scale of 0 to 3 that is (i.e.) 0 = No itch, 1 = low, 2 = Moderate and 3 = Severe, where higher score indicated very severe itch. All missing values were imputed by LOCF.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>CD5024 0.3% cream</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CD5024 0.3% cream</intervention_name>
    <description>Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 milligrams per centimeter square (mg/cm^2) once daily for 6 weeks.</description>
    <arm_group_label>CD5024 0.3% cream</arm_group_label>
    <other_name>Ivermectin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The participant was a male or female aged 18 to 60 years old inclusive at Screening.&#xD;
&#xD;
          2. The participant presented with a total body surface area (tBSA) less than or equal to&#xD;
             (&gt;=) 2 square meter (m^2) at Screening.&#xD;
&#xD;
          3. The participant had atopic dermatitis for at least 6 months prior to Day 1. The&#xD;
             clinical diagnosis of atopic dermatitis must be confirmed with the criteria of Hanifin&#xD;
             and Rajka at the screening visit.&#xD;
&#xD;
          4. Atopic dermatitis must be stable for at least one month before the screening visit&#xD;
             (according to participant).&#xD;
&#xD;
          5. The participant had a Body Surface Area (BSA) affected by AD ranging from 1% inclusive&#xD;
             to 10% inclusive at Day 1, excluding scalp and genitals.&#xD;
&#xD;
          6. The participant had an overall Investigator's Global Assessment (IGA) score of 3&#xD;
             (moderate) at Day 1;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The participant was a pregnant female, is breastfeeding or intends to conceive a child&#xD;
             during the study,&#xD;
&#xD;
          2. The participant had any uncontrolled or serious disease, or any medical or surgical&#xD;
             condition, that may either interfere with the interpretation of the clinical trial&#xD;
             results (e.g. extensive scaring or pigmented lesion in a treated area), and/or put the&#xD;
             participant at significant risk according to Investigator's judgment if he/she&#xD;
             participates in the clinical trial (e.g. active cancer, AIDS, insulin-dependent&#xD;
             diabetes…) at Screening or Day 1.&#xD;
&#xD;
          3. The participant presented with an acute flare of AD at Day 1.&#xD;
&#xD;
          4. The participant had active cutaneous bacterial or viral infection in any treated area&#xD;
             at baseline (e.g. clinically infected AD) at Screening or Day 1.&#xD;
&#xD;
          5. The participant had a history of confounding skin condition (e.g. psoriasis,&#xD;
             erythroderma) or a history of Netherton syndrome at Screening.&#xD;
&#xD;
          6. The participant had a past history of serious persistent neurological disorders such&#xD;
             as seizures, multiple sclerosis, or neurological signs or symptoms at Screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Galderma Investigational Site (#8581)</name>
      <address>
        <city>Mississauga</city>
        <state>Ontario</state>
        <zip>L5H 1G9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site (# 8338)</name>
      <address>
        <city>Richmond Hill</city>
        <state>Ontario</state>
        <zip>L4B 1A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site (#8587)</name>
      <address>
        <city>Richmond Hill</city>
        <state>Ontario</state>
        <zip>L4C 9M7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site (# 8060)</name>
      <address>
        <city>Windsor</city>
        <state>Ontario</state>
        <zip>N8W 5L7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site (#8089)</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2K 4L5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <results_first_submitted>June 27, 2022</results_first_submitted>
  <results_first_submitted_qc>June 27, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">May 1, 2023</results_first_posted>
  <last_update_submitted>June 27, 2022</last_update_submitted>
  <last_update_submitted_qc>June 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2023</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>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ivermectin</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 13, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03250624/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03250624/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted at 5 centers in Canada between 01 November 2016 and 26 June 2017.</recruitment_details>
      <pre_assignment_details>A total of 101 participants were screened in the study. Out of which, 63 participants were randomized in a ratio of 1:1 to receive CD5024 0.3 percent (%) cream or its vehicle. Screen failures were mainly due to exclusion criteria met.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>CD5024 0.3% Cream</title>
          <description>Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 milligrams per centimeters square (mg/cm^2) once daily for 6 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Intent-to-treat (ITT) efficacy analysis set was defined as any participants who are randomized.</population>
      <group_list>
        <group group_id="B1">
          <title>CD5024 0.3% Cream</title>
          <description>Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="32"/>
            <count group_id="B2" value="31"/>
            <count group_id="B3" value="63"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.2" spread="9.19"/>
                    <measurement group_id="B2" value="30.0" spread="10.77"/>
                    <measurement group_id="B3" value="28.6" spread="9.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Eczema Area and Severity Index (EASI) Score</title>
          <description>The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores indicated the worse severity of AD.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.341" spread="2.432"/>
                    <measurement group_id="B2" value="5.371" spread="2.652"/>
                    <measurement group_id="B3" value="5.356" spread="2.542"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Eczema Area and Severity Index (EASI) Score at Day 43</title>
        <description>The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum), with the higher scores indicated the worse severity of AD. All missing values were imputed by Last Observation Carried Forward (LOCF).</description>
        <time_frame>Baseline, Day 43</time_frame>
        <population>The Intent-to-treat (ITT) efficacy analysis set was defined as any participant who were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>CD5024 0.3% Cream</title>
            <description>Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Eczema Area and Severity Index (EASI) Score at Day 43</title>
          <description>The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum), with the higher scores indicated the worse severity of AD. All missing values were imputed by Last Observation Carried Forward (LOCF).</description>
          <population>The Intent-to-treat (ITT) efficacy analysis set was defined as any participant who were randomized.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.64" spread="0.41"/>
                    <measurement group_id="O2" value="-2.36" spread="0.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.632</p_value>
            <method>ANCOVA</method>
            <param_type>Least Square (LS) Mean Difference</param_type>
            <param_value>-0.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.46</ci_lower_limit>
            <ci_upper_limit>0.89</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in EASI at Each Visit</title>
        <description>The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores indicated the worse severity of AD. All missing values were imputed by LOCF.</description>
        <time_frame>Baseline, Days 8,15, 22, 29, 36 and 43</time_frame>
        <population>The ITT efficacy analysis set was defined as any participant who were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>CD5024 0.3% Cream</title>
            <description>Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in EASI at Each Visit</title>
          <description>The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores indicated the worse severity of AD. All missing values were imputed by LOCF.</description>
          <population>The ITT efficacy analysis set was defined as any participant who were randomized.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.7" spread="19.1"/>
                    <measurement group_id="O2" value="-5.5" spread="39.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.0" spread="37.5"/>
                    <measurement group_id="O2" value="-10.7" spread="43.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-29.1" spread="40.7"/>
                    <measurement group_id="O2" value="-26.7" spread="35.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-34.5" spread="59.9"/>
                    <measurement group_id="O2" value="-21.0" spread="41.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-43.1" spread="35.3"/>
                    <measurement group_id="O2" value="-28.8" spread="44.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-46.4" spread="38.8"/>
                    <measurement group_id="O2" value="-24.6" spread="62.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear)</title>
        <description>IGA scale consisted of 5 grades (0-4) among which 0 = Clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting), 1 = Almost clear (Trace, faint pink erythema with almost no induration/papulation and no oozing/crusting), 2 = Mild (Faint pink erythema with mild induration/papulation and no oozing/crusting), 3 = Moderate (Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting.), 4 = Severe (Deep/bright red erythema with severe induration/papulation with oozing/crusting). Success rate was defined as percentage of participants who achieved an IGA score of 1 (almost clear) or 0 (Clear) at specified visits. All missing values were imputed by LOCF.</description>
        <time_frame>Days 8, 15, 22, 29, 36 and 43</time_frame>
        <population>The ITT efficacy analysis set was defined as any participant who were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>CD5024 0.3% Cream</title>
            <description>Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear)</title>
          <description>IGA scale consisted of 5 grades (0-4) among which 0 = Clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting), 1 = Almost clear (Trace, faint pink erythema with almost no induration/papulation and no oozing/crusting), 2 = Mild (Faint pink erythema with mild induration/papulation and no oozing/crusting), 3 = Moderate (Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting.), 4 = Severe (Deep/bright red erythema with severe induration/papulation with oozing/crusting). Success rate was defined as percentage of participants who achieved an IGA score of 1 (almost clear) or 0 (Clear) at specified visits. All missing values were imputed by LOCF.</description>
          <population>The ITT efficacy analysis set was defined as any participant who were randomized.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.13"/>
                    <measurement group_id="O2" value="6.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.38"/>
                    <measurement group_id="O2" value="9.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.6"/>
                    <measurement group_id="O2" value="6.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.9"/>
                    <measurement group_id="O2" value="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.5"/>
                    <measurement group_id="O2" value="9.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Total Sum Score (TSS) at Each Visit</title>
        <description>The TSS was the sum of individual clinical severity scores for 5 signs of AD (erythema, induration/papulation, oozing/crusting, excoriation and lichenification). The severity of each sign was evaluated by using a 4-graded scale (0: none; 1: mild; 2: moderate; 3: severe). The total score ranges from 0 to 15, where higher score indicated worse severity of AD. All missing values were imputed by LOCF.</description>
        <time_frame>Baseline, Days 8, 15, 22, 29, 36 and 43</time_frame>
        <population>The ITT efficacy analysis set was defined as any participant who were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>CD5024 0.3% Cream</title>
            <description>Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Total Sum Score (TSS) at Each Visit</title>
          <description>The TSS was the sum of individual clinical severity scores for 5 signs of AD (erythema, induration/papulation, oozing/crusting, excoriation and lichenification). The severity of each sign was evaluated by using a 4-graded scale (0: none; 1: mild; 2: moderate; 3: severe). The total score ranges from 0 to 15, where higher score indicated worse severity of AD. All missing values were imputed by LOCF.</description>
          <population>The ITT efficacy analysis set was defined as any participant who were randomized.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.35" spread="4.51"/>
                    <measurement group_id="O2" value="-17.30" spread="4.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.94" spread="5.76"/>
                    <measurement group_id="O2" value="-20.82" spread="6.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-29.38" spread="6.23"/>
                    <measurement group_id="O2" value="-33.57" spread="6.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-37.23" spread="6.64"/>
                    <measurement group_id="O2" value="-34.44" spread="6.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-45.01" spread="6.75"/>
                    <measurement group_id="O2" value="42.24" spread="7.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-47.63" spread="7.30"/>
                    <measurement group_id="O2" value="-45.00" spread="7.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit</title>
        <description>SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with visual analog scale (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), &amp; subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. Higher scores indicated worse outcome. All missing values were imputed by LOCF.</description>
        <time_frame>Baseline, Days 8, 15, 22, 29, 36 and 43</time_frame>
        <population>The ITT efficacy analysis set was defined as any participant who were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>CD5024 0.3% Cream</title>
            <description>Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit</title>
          <description>SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with visual analog scale (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), &amp; subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. Higher scores indicated worse outcome. All missing values were imputed by LOCF.</description>
          <population>The ITT efficacy analysis set was defined as any participant who were randomized.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.28" spread="4.29"/>
                    <measurement group_id="O2" value="-16.00" spread="4.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.76" spread="5.51"/>
                    <measurement group_id="O2" value="-20.49" spread="5.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-32.02" spread="5.84"/>
                    <measurement group_id="O2" value="-30.73" spread="6.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-39.14" spread="6.51"/>
                    <measurement group_id="O2" value="-31.81" spread="6.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-46.38" spread="6.67"/>
                    <measurement group_id="O2" value="-40.10" spread="7.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-48.92" spread="7.26"/>
                    <measurement group_id="O2" value="-41.48" spread="7.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit</title>
        <description>Pruritus NRS was a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 = 'no itch' and 10 = 'worst itch imaginable', where higher score indicated very severe itch. All missing values were imputed by LOCF.</description>
        <time_frame>Baseline, Weeks 1, 2, 3, 4, 5 and 6</time_frame>
        <population>The ITT efficacy analysis set was defined as any participant who were randomized. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>CD5024 0.3% Cream</title>
            <description>Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit</title>
          <description>Pruritus NRS was a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 = 'no itch' and 10 = 'worst itch imaginable', where higher score indicated very severe itch. All missing values were imputed by LOCF.</description>
          <population>The ITT efficacy analysis set was defined as any participant who were randomized. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="1.1"/>
                    <measurement group_id="O2" value="-0.2" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="1.9"/>
                    <measurement group_id="O2" value="-0.3" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="2.1"/>
                    <measurement group_id="O2" value="-0.4" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="2.3"/>
                    <measurement group_id="O2" value="-0.3" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="2.2"/>
                    <measurement group_id="O2" value="-0.5" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="2.4"/>
                    <measurement group_id="O2" value="-0.6" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pruritus Verbal Rating Scale (VRS) Score at Day 43</title>
        <description>Participants were asked for a response that best described their pruritus intensity in last 24 hours, to rate their itch using a list of adjectives describing different levels of symptom intensity rated on a scale of 0 to 3 that is (i.e.) 0 = No itch, 1 = low, 2 = Moderate and 3 = Severe, where higher score indicated very severe itch. All missing values were imputed by LOCF.</description>
        <time_frame>Baseline, Day 43</time_frame>
        <population>The ITT efficacy analysis set was defined as any participant who were randomized. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>CD5024 0.3% Cream</title>
            <description>Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pruritus Verbal Rating Scale (VRS) Score at Day 43</title>
          <description>Participants were asked for a response that best described their pruritus intensity in last 24 hours, to rate their itch using a list of adjectives describing different levels of symptom intensity rated on a scale of 0 to 3 that is (i.e.) 0 = No itch, 1 = low, 2 = Moderate and 3 = Severe, where higher score indicated very severe itch. All missing values were imputed by LOCF.</description>
          <population>The ITT efficacy analysis set was defined as any participant who were randomized. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.31" spread="0.79"/>
                    <measurement group_id="O2" value="-.13" spread="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Week 9</time_frame>
      <desc>The Safety set included all randomized participants who applied/were administered the study drug(s) at least once.</desc>
      <group_list>
        <group group_id="E1">
          <title>CD5024 0.3% Cream</title>
          <description>Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA v19.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eyelid pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Blepharitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Vessel puncture site bruise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Furuncle</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Tinea cruris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Burns first degree</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Post procedural inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Face injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Skin papilloma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis atopic</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Skin burning sensation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Skin irritation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Operations</name_or_title>
      <organization>Galderma</organization>
      <phone>817 961 5000 ext 1</phone>
      <email>Clinical.Studies@galderma.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03250624
org study id: RD.03.SPR.109696
nct id: NCT03250624
lead sponsor: 
has dmc: No
Exploratory, multi-centric, randomized, vehicle-controlled, investigator-blind, parallel
      group study, involved participants with chronic lesions of Atopic Dermatitis (AD) to evaluate
      the local and systemic safety of CD5024 0.3% cream over a 6-week treatment period compared to
      its vehicle.
Study application was performed once daily, 7 days a week for 6 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Investigator)
measure: Change From Baseline in Eczema Area and Severity Index (EASI) Score at Day 43
time frame: Baseline, Day 43
description: The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum), with the higher scores indicated the worse severity of AD. All missing values were imputed by Last Observation Carried Forward (LOCF).
measure: Percent Change From Baseline in EASI at Each Visit
time frame: Baseline, Days 8,15, 22, 29, 36 and 43
description: The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores indicated the worse severity of AD. All missing values were imputed by LOCF.
measure: Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear)
time frame: Days 8, 15, 22, 29, 36 and 43
description: IGA scale consisted of 5 grades (0-4) among which 0 = Clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting), 1 = Almost clear (Trace, faint pink erythema with almost no induration/papulation and no oozing/crusting), 2 = Mild (Faint pink erythema with mild induration/papulation and no oozing/crusting), 3 = Moderate (Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting.), 4 = Severe (Deep/bright red erythema with severe induration/papulation with oozing/crusting). Success rate was defined as percentage of participants who achieved an IGA score of 1 (almost clear) or 0 (Clear) at specified visits. All missing values were imputed by LOCF.
measure: Percent Change From Baseline in Total Sum Score (TSS) at Each Visit
time frame: Baseline, Days 8, 15, 22, 29, 36 and 43
description: The TSS was the sum of individual clinical severity scores for 5 signs of AD (erythema, induration/papulation, oozing/crusting, excoriation and lichenification). The severity of each sign was evaluated by using a 4-graded scale (0: none; 1: mild; 2: moderate; 3: severe). The total score ranges from 0 to 15, where higher score indicated worse severity of AD. All missing values were imputed by LOCF.
measure: Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit
time frame: Baseline, Days 8, 15, 22, 29, 36 and 43
description: SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with visual analog scale (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. Higher scores indicated worse outcome. All missing values were imputed by LOCF.
measure: Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit
time frame: Baseline, Weeks 1, 2, 3, 4, 5 and 6
description: Pruritus NRS was a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 = 'no itch' and 10 = 'worst itch imaginable', where higher score indicated very severe itch. All missing values were imputed by LOCF.
measure: Change From Baseline in Pruritus Verbal Rating Scale (VRS) Score at Day 43
time frame: Baseline, Day 43
description: Participants were asked for a response that best described their pruritus intensity in last 24 hours, to rate their itch using a list of adjectives describing different levels of symptom intensity rated on a scale of 0 to 3 that is (i.e.) 0 = No itch, 1 = low, 2 = Moderate and 3 = Severe, where higher score indicated very severe itch. All missing values were imputed by LOCF.
arm group label: CD5024 0.3% cream
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: CD5024 0.3% cream
description: Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 milligrams per centimeter square (mg/cm^2) once daily for 6 weeks.
arm group label: CD5024 0.3% cream
other name: Ivermectin
intervention type: Drug
intervention name: Placebo
description: Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
mesh term: Ivermectin
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 