<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/NCT03002571</url>
  </required_header>
  <id_info>
    <org_study_id>V01-124A-301</org_study_id>
    <nct_id>NCT03002571</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects (301)</brief_title>
  <official_title>A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Study to Evaluate the Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bausch Health Americas, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bausch Health Americas, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic&#xD;
      Dermatitis in Pediatric and Adult Subjects&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Study to Evaluate the Efficacy&#xD;
      and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in&#xD;
      Pediatric and Adult Subjects&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 24, 2018</start_date>
  <completion_date type="Actual">April 14, 2020</completion_date>
  <primary_completion_date type="Actual">April 14, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline at Week 6 in the Investigator Global Assessment (IGA) Scale and Had an IGA at Week 6 That Equated to &quot;Clear&quot; or &quot;Almost Clear&quot;</measure>
    <time_frame>Baseline to Week 6</time_frame>
    <description>Investigator Global Assessment (IGA) was determined based on evaluator-blinded evaluations of the inflammatory signs of atopic dermatitis. Evaluations were scored using a 5-point scale from clear (0) to severe (4), with higher numbers indicating worse scores.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline in the Investigator Global Assessment (IGA) Scale and Had an IGA That Equated to &quot;Clear&quot; or &quot;Almost Clear&quot;</measure>
    <time_frame>Baseline to Week 10</time_frame>
    <description>Investigator Global Assessment (IGA) was determined based on evaluator-blinded evaluations of the inflammatory signs of atopic dermatitis. Evaluations were scored using a 5-point scale from clear (0) to severe (4), with higher numbers indicating worse scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Had Eczema Area Severity Index (EASI) 75</measure>
    <time_frame>Baseline to Week 10</time_frame>
    <description>EASI 75 is defined as at least a 75% reduction in the Eczema Area Severity Index (EASI) score from Baseline. EASI is composite score based on the evaluated severity of 4 key signs of AD (i.e., erythema, infiltration/papulation, excoriation and lichenification), and the extent of disease in each of the 4 body regions (i.e., head/neck, trunk, upper limbs, and lower limbs). The area of involvement (affected by inflammation, not including dry skin) of each of the 4 body regions is determined and represented by a numeric coded value based on a scale from 0 to 6. The 4 body regions are assessed separately for each sign/symptom, and the average degree of severity of each sign in each of the 4 body parts is assigned a score of 0 (none) to 3 (severe) on a scale that allows half-unit increments. The EASI score ranges from 0 to 72, with higher scores being worse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Had at Least a 1 Grade Improvement From Baseline in the Severity of Pruritus Score and a Pruritus Score Equating to &quot;None&quot; or &quot;Mild&quot;</measure>
    <time_frame>Baseline to Week 2</time_frame>
    <description>Pruritis was assessed on a 4-point scale with 0 (none) to 3 (severe) and higher scores being worse.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">338</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>IDP-124 Lotion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IDP-124 Lotion, twice-daily application</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IDP-124 Vehicle Lotion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>IDP-124 Vehicle Lotion, twice-daily application</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IDP-124 Lotion</intervention_name>
    <description>IDP-124 Lotion, twice-daily application</description>
    <arm_group_label>IDP-124 Lotion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IDP-124 Vehicle Lotion</intervention_name>
    <description>IDP-124 Vehicle Lotion, twice-daily application</description>
    <arm_group_label>IDP-124 Vehicle Lotion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Male or female at least 2 years of age and older&#xD;
&#xD;
          -  Written and verbal informed consent must be obtained; subjects less than age of&#xD;
             consent must sign an assent for the study and a parent or a legal guardian must sign&#xD;
             the informed consent (if subject reaches age of consent during the study they should&#xD;
             be re-consented at the next study visit)&#xD;
&#xD;
          -  Nonimmunocompromized male or female who failed to respond adequately to other topical&#xD;
             prescription treatment for AD or for whom those treatments are not advisable&#xD;
&#xD;
          -  Subjects must be willing to comply with study instructions and return to the clinic&#xD;
             for required visits; subjects under the age of consent must be accompanied by the&#xD;
             parent or legal guardian at the time of assent/consent signing&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Females who are pregnant, breast feeding, or who wish to become pregnant during the&#xD;
             study period&#xD;
&#xD;
          -  Active cutaneous bacterial or viral infection in any treatment area at Baseline (eg,&#xD;
             clinically infected AD)&#xD;
&#xD;
          -  Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at Baseline,&#xD;
             which would interfere with evaluations&#xD;
&#xD;
          -  History of confounding skin conditions, eg, psoriasis, rosacea, erythroderma, or&#xD;
             ichthyosis (other than ichthyosis vulgaris)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Binu Alexander, MD</last_name>
    <role>Study Director</role>
    <affiliation>Valeant Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Valeant Site 01</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <results_first_submitted>April 12, 2023</results_first_submitted>
  <results_first_submitted_qc>April 12, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">May 8, 2023</results_first_posted>
  <disposition_first_submitted>April 12, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>April 12, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">April 13, 2021</disposition_first_posted>
  <last_update_submitted>April 12, 2023</last_update_submitted>
  <last_update_submitted_qc>April 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 25, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT03002571/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>IDP-124 Lotion</title>
          <description>IDP-124 Lotion, twice-daily application</description>
        </group>
        <group group_id="P2">
          <title>IDP-124 Vehicle Lotion</title>
          <description>IDP-124 Vehicle Lotion, twice-daily application</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="224"/>
                <participants group_id="P2" count="113"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="202"/>
                <participants group_id="P2" count="99"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>IDP-124 Lotion</title>
          <description>IDP-124 Lotion, twice-daily application</description>
        </group>
        <group group_id="B2">
          <title>IDP-124 Vehicle Lotion</title>
          <description>IDP-124 Vehicle Lotion, twice-daily application</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="224"/>
            <count group_id="B2" value="113"/>
            <count group_id="B3" value="337"/>
          </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="34.7" spread="20.16"/>
                    <measurement group_id="B2" value="30.0" spread="19.92"/>
                    <measurement group_id="B3" value="33.1" spread="20.18"/>
                  </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="138"/>
                    <measurement group_id="B2" value="73"/>
                    <measurement group_id="B3" value="211"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="126"/>
                  </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="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="89"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="131"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="90"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="145"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline at Week 6 in the Investigator Global Assessment (IGA) Scale and Had an IGA at Week 6 That Equated to &quot;Clear&quot; or &quot;Almost Clear&quot;</title>
        <description>Investigator Global Assessment (IGA) was determined based on evaluator-blinded evaluations of the inflammatory signs of atopic dermatitis. Evaluations were scored using a 5-point scale from clear (0) to severe (4), with higher numbers indicating worse scores.</description>
        <time_frame>Baseline to Week 6</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IDP-124 Lotion</title>
            <description>IDP-124 Lotion, twice-daily application</description>
          </group>
          <group group_id="O2">
            <title>IDP-124 Vehicle Lotion</title>
            <description>IDP-124 Vehicle Lotion, twice-daily application</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline at Week 6 in the Investigator Global Assessment (IGA) Scale and Had an IGA at Week 6 That Equated to &quot;Clear&quot; or &quot;Almost Clear&quot;</title>
          <description>Investigator Global Assessment (IGA) was determined based on evaluator-blinded evaluations of the inflammatory signs of atopic dermatitis. Evaluations were scored using a 5-point scale from clear (0) to severe (4), with higher numbers indicating worse scores.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="224"/>
                <count group_id="O2" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.95"/>
                    <measurement group_id="O2" value="27.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline in the Investigator Global Assessment (IGA) Scale and Had an IGA That Equated to &quot;Clear&quot; or &quot;Almost Clear&quot;</title>
        <description>Investigator Global Assessment (IGA) was determined based on evaluator-blinded evaluations of the inflammatory signs of atopic dermatitis. Evaluations were scored using a 5-point scale from clear (0) to severe (4), with higher numbers indicating worse scores.</description>
        <time_frame>Baseline to Week 10</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IDP-124 Lotion</title>
            <description>IDP-124 Lotion, twice-daily application</description>
          </group>
          <group group_id="O2">
            <title>IDP-124 Vehicle Lotion</title>
            <description>IDP-124 Vehicle Lotion, twice-daily application</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline in the Investigator Global Assessment (IGA) Scale and Had an IGA That Equated to &quot;Clear&quot; or &quot;Almost Clear&quot;</title>
          <description>Investigator Global Assessment (IGA) was determined based on evaluator-blinded evaluations of the inflammatory signs of atopic dermatitis. Evaluations were scored using a 5-point scale from clear (0) to severe (4), with higher numbers indicating worse scores.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="224"/>
                <count group_id="O2" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.82"/>
                    <measurement group_id="O2" value="5.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.25"/>
                    <measurement group_id="O2" value="16.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.71"/>
                    <measurement group_id="O2" value="24.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Had Eczema Area Severity Index (EASI) 75</title>
        <description>EASI 75 is defined as at least a 75% reduction in the Eczema Area Severity Index (EASI) score from Baseline. EASI is composite score based on the evaluated severity of 4 key signs of AD (i.e., erythema, infiltration/papulation, excoriation and lichenification), and the extent of disease in each of the 4 body regions (i.e., head/neck, trunk, upper limbs, and lower limbs). The area of involvement (affected by inflammation, not including dry skin) of each of the 4 body regions is determined and represented by a numeric coded value based on a scale from 0 to 6. The 4 body regions are assessed separately for each sign/symptom, and the average degree of severity of each sign in each of the 4 body parts is assigned a score of 0 (none) to 3 (severe) on a scale that allows half-unit increments. The EASI score ranges from 0 to 72, with higher scores being worse.</description>
        <time_frame>Baseline to Week 10</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IDP-124 Lotion</title>
            <description>IDP-124 Lotion, twice-daily application</description>
          </group>
          <group group_id="O2">
            <title>IDP-124 Vehicle Lotion</title>
            <description>IDP-124 Vehicle Lotion, twice-daily application</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had Eczema Area Severity Index (EASI) 75</title>
          <description>EASI 75 is defined as at least a 75% reduction in the Eczema Area Severity Index (EASI) score from Baseline. EASI is composite score based on the evaluated severity of 4 key signs of AD (i.e., erythema, infiltration/papulation, excoriation and lichenification), and the extent of disease in each of the 4 body regions (i.e., head/neck, trunk, upper limbs, and lower limbs). The area of involvement (affected by inflammation, not including dry skin) of each of the 4 body regions is determined and represented by a numeric coded value based on a scale from 0 to 6. The 4 body regions are assessed separately for each sign/symptom, and the average degree of severity of each sign in each of the 4 body parts is assigned a score of 0 (none) to 3 (severe) on a scale that allows half-unit increments. The EASI score ranges from 0 to 72, with higher scores being worse.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="224"/>
                <count group_id="O2" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.79"/>
                    <measurement group_id="O2" value="26.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.61"/>
                    <measurement group_id="O2" value="37.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.68"/>
                    <measurement group_id="O2" value="33.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Had at Least a 1 Grade Improvement From Baseline in the Severity of Pruritus Score and a Pruritus Score Equating to &quot;None&quot; or &quot;Mild&quot;</title>
        <description>Pruritis was assessed on a 4-point scale with 0 (none) to 3 (severe) and higher scores being worse.</description>
        <time_frame>Baseline to Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IDP-124 Lotion</title>
            <description>IDP-124 Lotion, twice-daily application</description>
          </group>
          <group group_id="O2">
            <title>IDP-124 Vehicle Lotion</title>
            <description>IDP-124 Vehicle Lotion, twice-daily application</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had at Least a 1 Grade Improvement From Baseline in the Severity of Pruritus Score and a Pruritus Score Equating to &quot;None&quot; or &quot;Mild&quot;</title>
          <description>Pruritis was assessed on a 4-point scale with 0 (none) to 3 (severe) and higher scores being worse.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="224"/>
                <count group_id="O2" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.20"/>
                    <measurement group_id="O2" value="34.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.34"/>
                    <measurement group_id="O2" value="43.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>10 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>IDP-124 Lotion</title>
          <description>IDP-124 Lotion, twice-daily application</description>
        </group>
        <group group_id="E2">
          <title>IDP-124 Vehicle Lotion</title>
          <description>IDP-124 Vehicle Lotion, twice-daily application</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="224"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="113"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="224"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="113"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.0</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="8" subjects_at_risk="224"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="113"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application site dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="224"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="113"/>
              </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>Contact sponsor for details.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Bausch Health Americas, Inc</organization>
      <phone>19083009920</phone>
      <email>susan.harris@bauschhealth.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/NCT03002571
org study id: V01-124A-301
nct id: NCT03002571
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic
      Dermatitis in Pediatric and Adult Subjects
A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Study to Evaluate the Efficacy
      and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in
      Pediatric and Adult Subjects
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline at Week 6 in the Investigator Global Assessment (IGA) Scale and Had an IGA at Week 6 That Equated to "Clear" or "Almost Clear"
time frame: Baseline to Week 6
description: Investigator Global Assessment (IGA) was determined based on evaluator-blinded evaluations of the inflammatory signs of atopic dermatitis. Evaluations were scored using a 5-point scale from clear (0) to severe (4), with higher numbers indicating worse scores.
measure: Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline in the Investigator Global Assessment (IGA) Scale and Had an IGA That Equated to "Clear" or "Almost Clear"
time frame: Baseline to Week 10
description: Investigator Global Assessment (IGA) was determined based on evaluator-blinded evaluations of the inflammatory signs of atopic dermatitis. Evaluations were scored using a 5-point scale from clear (0) to severe (4), with higher numbers indicating worse scores.
measure: Percentage of Participants Who Had Eczema Area Severity Index (EASI) 75
time frame: Baseline to Week 10
description: EASI 75 is defined as at least a 75% reduction in the Eczema Area Severity Index (EASI) score from Baseline. EASI is composite score based on the evaluated severity of 4 key signs of AD (i.e., erythema, infiltration/papulation, excoriation and lichenification), and the extent of disease in each of the 4 body regions (i.e., head/neck, trunk, upper limbs, and lower limbs). The area of involvement (affected by inflammation, not including dry skin) of each of the 4 body regions is determined and represented by a numeric coded value based on a scale from 0 to 6. The 4 body regions are assessed separately for each sign/symptom, and the average degree of severity of each sign in each of the 4 body parts is assigned a score of 0 (none) to 3 (severe) on a scale that allows half-unit increments. The EASI score ranges from 0 to 72, with higher scores being worse.
measure: Percentage of Participants Who Had at Least a 1 Grade Improvement From Baseline in the Severity of Pruritus Score and a Pruritus Score Equating to "None" or "Mild"
time frame: Baseline to Week 2
description: Pruritis was assessed on a 4-point scale with 0 (none) to 3 (severe) and higher scores being worse.
arm group label: IDP-124 Lotion
arm group type: Experimental
description: IDP-124 Lotion, twice-daily application
arm group label: IDP-124 Vehicle Lotion
arm group type: Active Comparator
description: IDP-124 Vehicle Lotion, twice-daily application
intervention type: Drug
intervention name: IDP-124 Lotion
description: IDP-124 Lotion, twice-daily application
arm group label: IDP-124 Lotion
intervention type: Drug
intervention name: IDP-124 Vehicle Lotion
description: IDP-124 Vehicle Lotion, twice-daily application
arm group label: IDP-124 Vehicle Lotion
criteria: 
gender: All
minimum age: 2 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Binu Alexander, MD
role: Study Director
affiliation: Valeant Pharmaceuticals
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 