<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/NCT04498403</url>
  </required_header>
  <id_info>
    <org_study_id>C3291027</org_study_id>
    <nct_id>NCT04498403</nct_id>
  </id_info>
  <brief_title>A Study of the Long-Term Safety of Crisaborole Ointment, 2% in Japanese Pediatric and Adult Participants With Mild to Moderate Atopic Dermatitis</brief_title>
  <official_title>A PHASE 3, MULTICENTER, OPEN-LABEL STUDY OF THE LONG-TERM SAFETY OF CRISABOROLE OINTMENT, 2% IN JAPANESE PEDIATRIC AND ADULT PARTICIPANTS WITH MILD TO MODERATE ATOPIC DERMATITIS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a Phase 3, multicenter, open-label, long-term safety extension study of Studies&#xD;
      C3291032 and C3291031 in Japanese pediatric and adult participants with mild to moderate&#xD;
      Atopic Dermatitis (AD).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Terminated (This decision was made for business reasons only and is not related to any safety&#xD;
    concerns regarding crisaborole.)&#xD;
  </why_stopped>
  <start_date type="Actual">September 14, 2020</start_date>
  <completion_date type="Actual">December 18, 2020</completion_date>
  <primary_completion_date type="Actual">December 18, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)</time_frame>
    <description>An adverse events (AE) is any untoward medical occurrence in clinical investigation participant administered a product or medical device; event need not necessarily to had a causal relationship with treatment or usage. SAEs: an AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to 28 days after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Crisaborole 2%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Crisaborole 2% ointment applied twice daily (BID)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Crisaborole 2%</intervention_name>
    <description>Crisaborole 2% ointment</description>
    <arm_group_label>Crisaborole 2%</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female participants;&#xD;
&#xD;
          -  Who were patients with mild to moderate AD aged 2 years old or older and met&#xD;
             eligibility criteria for study C3291032 at the time when entering Study C3291032, and&#xD;
             completed treatment period in Study C3291032 without safety issues. Or&#xD;
&#xD;
          -  Who were patients with mild to moderate AD aged 1 months to &lt;24 months and met&#xD;
             eligibility criteria for Study C3291031 at the time when entering Study C3291031, and&#xD;
             completed treatment period in Study C3291031 without safety issues&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has other medical or psychiatric condition including recent (within the past year) or&#xD;
             active suicidal ideation/behavior or laboratory abnormality that may increase the risk&#xD;
             of study participation or, in the investigator's judgment, make the participant&#xD;
             inappropriate for the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shirao Clinic of Pediatrics and Pediatric Allergy</name>
      <address>
        <city>Hiroshima-shi</city>
        <state>Hiroshima</state>
        <zip>734-0023</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chitose dermatology and plastic surgery clinic</name>
      <address>
        <city>Chitose Shi</city>
        <state>Hokkaido</state>
        <zip>066-0021</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takagi Dermatological Clinic</name>
      <address>
        <city>Obihiro</city>
        <state>Hokkaido</state>
        <zip>080-0013</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yoshimura Child Clinic</name>
      <address>
        <city>Akashi-City</city>
        <state>Hyōgo</state>
        <zip>674-0068</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iryouhoujinshadan Yamayurikai Tsujino. Kodomo Clinic</name>
      <address>
        <city>Kobe-City</city>
        <state>Hyōgo</state>
        <zip>658-0082</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Noguchi Dermatology Clinic</name>
      <address>
        <city>Kamimashiki-gun</city>
        <state>Kumamoto</state>
        <zip>861-3101</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yoshioka Dermatology Clinic</name>
      <address>
        <city>Neyagawa</city>
        <state>Osaka</state>
        <zip>572-0838</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mildix Skin Clinic</name>
      <address>
        <city>Adachi-ku</city>
        <state>Tokyo</state>
        <zip>120-0034</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yoga Allergy Clinic</name>
      <address>
        <city>Setagaya-ku</city>
        <state>Tokyo</state>
        <zip>158-0097</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sugamo Kobayashi Derma Clinic</name>
      <address>
        <city>Toshima-Ku</city>
        <state>Tokyo</state>
        <zip>170-0002</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hoshikuma Dermatology・Allergy Clinic</name>
      <address>
        <city>Fukuoka</city>
        <zip>814-0171</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=C3291027</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <results_first_submitted>June 14, 2021</results_first_submitted>
  <results_first_submitted_qc>July 20, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 12, 2021</results_first_posted>
  <last_update_submitted>July 20, 2021</last_update_submitted>
  <last_update_submitted_qc>July 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Eczema</keyword>
  <keyword>Crisaborole</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
    <ipd_url>https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests</ipd_url>
  </patient_data>
  <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>May 20, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT04498403/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>January 7, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT04498403/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cohort 1: Crisaborole 2%, Age Group: Less Than (&lt;) 18 Years</title>
          <description>Participants aged &lt; 18 years with mild to moderate atopic dermatitis (AD) received crisaborole ointment, 2 percent (%) on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.</description>
        </group>
        <group group_id="P2">
          <title>Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (&gt;=) 18 Years</title>
          <description>Participants aged &gt;= 18 years with mild to moderate atopic dermatitis (AD) received crisaborole ointment, 2 percent (%) on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Follow up</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Terminated By Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety population included all participants who took at least 1 dose of study drug. Participants who entered the first Off-Treatment cycle were included.</population>
      <group_list>
        <group group_id="B1">
          <title>Cohort 1: Crisaborole 2%, Age Group: Less Than (&lt;) 18 Years</title>
          <description>Participants aged &lt; 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.</description>
        </group>
        <group group_id="B2">
          <title>Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (&gt;=) 18 Years</title>
          <description>Participants aged &gt;= 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.</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="30"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="40"/>
          </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="9.3" spread="3.99"/>
                    <measurement group_id="B2" value="31.8" spread="7.97"/>
                    <measurement group_id="B3" value="15.0" spread="11.11"/>
                  </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="15"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</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>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="40"/>
                  </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>
          <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="30"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="40"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</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>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="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>Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</title>
        <description>An adverse events (AE) is any untoward medical occurrence in clinical investigation participant administered a product or medical device; event need not necessarily to had a causal relationship with treatment or usage. SAEs: an AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to 28 days after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.</description>
        <time_frame>Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)</time_frame>
        <population>Safety population included all participants who took at least 1 dose of study drug. Participants who entered the first Off-Treatment cycle were included.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Crisaborole 2%, Age Group: Less Than (&lt;) 18 Years</title>
            <description>Participants aged &lt; 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (&gt;=) 18 Years</title>
            <description>Participants aged &gt;= 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</title>
          <description>An adverse events (AE) is any untoward medical occurrence in clinical investigation participant administered a product or medical device; event need not necessarily to had a causal relationship with treatment or usage. SAEs: an AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to 28 days after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.</description>
          <population>Safety population included all participants who took at least 1 dose of study drug. Participants who entered the first Off-Treatment cycle were included.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Cohort 1: Crisaborole 2%, Age Group: Less Than (&lt;) 18 Years</title>
          <description>Participants aged &lt; 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.</description>
        </group>
        <group group_id="E2">
          <title>Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (&gt;=) 18 Years</title>
          <description>Participants aged &gt;= 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.</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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA v23.1</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="11" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application site pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Molluscum contagiosum</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Joint effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dermatitis atopic</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </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>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Participants were planned to be followed up to Week 56, however due to early termination of the study, participants were followed up to only Week 12.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer Inc.</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.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/NCT04498403
org study id: C3291027
nct id: NCT04498403
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is a Phase 3, multicenter, open-label, long-term safety extension study of Studies
      C3291032 and C3291031 in Japanese pediatric and adult participants with mild to moderate
      Atopic Dermatitis (AD).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
time frame: Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
description: An adverse events (AE) is any untoward medical occurrence in clinical investigation participant administered a product or medical device; event need not necessarily to had a causal relationship with treatment or usage. SAEs: an AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to 28 days after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
arm group label: Crisaborole 2%
arm group type: Experimental
description: Crisaborole 2% ointment applied twice daily (BID)
intervention type: Drug
intervention name: Crisaborole 2%
description: Crisaborole 2% ointment
arm group label: Crisaborole 2%
criteria: 
gender: All
minimum age: 7 Months
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
url: https://pmiform.com/clinical-trial-info-request?StudyID=C3291027
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
sharing ipd: Yes
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
ipd url: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Participants were planned to be followed up to Week 56, however due to early termination of the study, participants were followed up to only Week 12.
point of contact: 