<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/NCT03278028</url>
  </required_header>
  <id_info>
    <org_study_id>A-101-WART-203</org_study_id>
    <nct_id>NCT03278028</nct_id>
  </id_info>
  <brief_title>A Study of A-101 Topical Solution Administered Twice a Week in Subjects With Common Warts</brief_title>
  <official_title>A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Topical Solution Applied Twice a Week in Subjects With Common Warts</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aclaris Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aclaris Therapeutics, 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>
      The primary objective of this study is to evaluate the effectiveness of A-101 compared to&#xD;
      Vehicle when applied to 1 Target common wart on the trunk or extremities twice a week.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to evaluate the effectiveness of A-101 compared to&#xD;
      Vehicle when applied to 1 Target common wart on the trunk or extremities twice a week.&#xD;
&#xD;
      The secondary objectives of this study are to evaluate the clinical effect of A-101 when&#xD;
      applied to all treated Warts (Target Warts plus Non-Target Warts) twice a week, duration of&#xD;
      response in all treated Warts (Target Warts plus Non-Target Warts), and safety of A-101.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 13, 2017</start_date>
  <completion_date type="Actual">March 1, 2018</completion_date>
  <primary_completion_date type="Actual">March 1, 2018</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physician's Wart Assessment</measure>
    <time_frame>Day 57</time_frame>
    <description>Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated.&#xD;
Near Clear: A visible wart that is less than 3 mm in maximal diameter (or length)&#xD;
A visible wart ≥ 3 mm and &lt; 6 mm in maximal diameter (or length)&#xD;
A visible wart ≥ 6 mm in maximal diameter (or length)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">159</enrollment>
  <condition>Common Wart</condition>
  <arm_group>
    <arm_group_label>Active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A-101 Topical Solutions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Vehicle</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>A-101 Topical Solution</intervention_name>
    <description>A-101 Topical Solution</description>
    <arm_group_label>Active</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>A-101 Vehicle Solution</intervention_name>
    <description>A-101 Vehicle Solution</description>
    <arm_group_label>Vehicle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is able to comprehend and is willing to sign an informed consent/assent for&#xD;
             participation in this study.&#xD;
&#xD;
          -  Male or female ≥ 8 years old.&#xD;
&#xD;
          -  Subject chemistry and complete blood count results are within normal limits. If any of&#xD;
             the laboratory values are outside normal range, the treating investigator must assess&#xD;
             the value/s as NOT clinically significant and document this in the subject's medical&#xD;
             chart in order for the subject to be eligible for randomization.&#xD;
&#xD;
          -  Woman of childbearing potential (WOCBP) must have a negative urine pregnancy test&#xD;
             within 14 days of the first application of study drug and agree to use an active&#xD;
             method of birth control for the duration of the study.&#xD;
&#xD;
          -  Subject is non-pregnant and non-lactating.&#xD;
&#xD;
          -  Subject is in good general health and free of any known disease state or physical&#xD;
             condition which, in the investigator's opinion, might impair the evaluation of any&#xD;
             Target and Non-Target Warts or which exposes the subject to an unacceptable risk by&#xD;
             study participation.&#xD;
&#xD;
          -  Subject is willing and able to follow all study instructions and to attend all study&#xD;
             visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has clinically atypical warts on the trunk or extremities.&#xD;
&#xD;
          -  Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic&#xD;
             immunodeficiency, transplant status, etc.)&#xD;
&#xD;
          -  Subject has a history of Human Immunodeficiency Virus (HIV) infection&#xD;
&#xD;
          -  Subject has had any Human Papilloma Virus (HPV) vaccine within 1 year prior to Visit 1&#xD;
&#xD;
          -  Subject has a history of sensitivity to any of the ingredients in the study&#xD;
             medications.&#xD;
&#xD;
          -  Subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun&#xD;
             damage), or condition (e.g., sunburn, excessive hair, open wounds) that, in the&#xD;
             opinion of the investigator, might put the subject at undue risk by study&#xD;
             participation or interfere with the study conduct or evaluations.&#xD;
&#xD;
          -  Participation in another therapeutic investigational drug trial in which&#xD;
             administration of an investigational study medication occurred with 30 days prior to&#xD;
             Visit 1.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stuart D Shanler, MD</last_name>
    <role>Study Director</role>
    <affiliation>Aclaris Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aclaris Investigational Site</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigational Site</name>
      <address>
        <city>Fort Smith</city>
        <state>Arkansas</state>
        <zip>72916</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigational Site</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigational Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigational Site</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigational Site</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigational Site</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigational Site</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14623</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigational Site</name>
      <address>
        <city>High Point</city>
        <state>South Carolina</state>
        <zip>27262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigational Site</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37922</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigational Site</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigational Site</name>
      <address>
        <city>College Station</city>
        <state>Texas</state>
        <zip>77845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigational Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigational Site</name>
      <address>
        <city>Lynchburg</city>
        <state>Virginia</state>
        <zip>24501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aclaris Investigational Site</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <results_first_submitted>March 7, 2019</results_first_submitted>
  <results_first_submitted_qc>March 7, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">March 29, 2019</results_first_posted>
  <last_update_submitted>April 1, 2019</last_update_submitted>
  <last_update_submitted_qc>April 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2019</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>Warts</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharmaceutical Solutions</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>November 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03278028/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>December 1, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03278028/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Active</title>
          <description>A-101 Topical Solutions&#xD;
A-101 Topical Solution: A-101 Topical Solution</description>
        </group>
        <group group_id="P2">
          <title>Vehicle</title>
          <description>Vehicle&#xD;
A-101 Vehicle Solution: A-101 Vehicle Solution</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="81"/>
                <participants group_id="P2" count="78"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="77"/>
                <participants group_id="P2" count="76"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Active</title>
          <description>A-101 Topical Solution&#xD;
A-101 Topical Solution: A-101 Topical Solution</description>
        </group>
        <group group_id="B2">
          <title>Vehicle</title>
          <description>Vehicle&#xD;
A-101 Vehicle Solution: A-101 Vehicle Solution</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="81"/>
            <count group_id="B2" value="78"/>
            <count group_id="B3" value="159"/>
          </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="37.96" spread="18.09"/>
                    <measurement group_id="B2" value="41.56" spread="17.42"/>
                    <measurement group_id="B3" value="39.73" spread="17.8"/>
                  </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="48"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="91"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="68"/>
                  </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="13"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="120"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="148"/>
                  </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="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Physician's Wart Assessment</title>
        <description>Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated.&#xD;
Near Clear: A visible wart that is less than 3 mm in maximal diameter (or length)&#xD;
A visible wart ≥ 3 mm and &lt; 6 mm in maximal diameter (or length)&#xD;
A visible wart ≥ 6 mm in maximal diameter (or length)</description>
        <time_frame>Day 57</time_frame>
        <population>Per-Protocol (PP)</population>
        <group_list>
          <group group_id="O1">
            <title>Active</title>
            <description>A-101 Topical Solution&#xD;
A-101 Topical Solution: A-101 Topical Solution</description>
          </group>
          <group group_id="O2">
            <title>Vehicle</title>
            <description>Vehicle&#xD;
A-101 Vehicle Solution: A-101 Vehicle Solution</description>
          </group>
        </group_list>
        <measure>
          <title>Physician's Wart Assessment</title>
          <description>Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated.&#xD;
Near Clear: A visible wart that is less than 3 mm in maximal diameter (or length)&#xD;
A visible wart ≥ 3 mm and &lt; 6 mm in maximal diameter (or length)&#xD;
A visible wart ≥ 6 mm in maximal diameter (or length)</description>
          <population>Per-Protocol (PP)</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="79"/>
                <count group_id="O2" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.52" spread="1.06"/>
                    <measurement group_id="O2" value="2.23" spread="0.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>78 days; Treatment-emergent adverse events (TEAEs) had a start date on or after the date of Visit 2 (study day 1) and treatment-emergent serious adverse events had a start date on or after the date of Visit 1 (Screening). Collection continued through visit 11 (Day 78)</time_frame>
      <desc>An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication.&#xD;
Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.</desc>
      <group_list>
        <group group_id="E1">
          <title>Active</title>
          <description>A-101 Topical Solution&#xD;
A-101 Topical Solution: A-101 Topical Solution</description>
        </group>
        <group group_id="E2">
          <title>Vehicle</title>
          <description>Vehicle&#xD;
A-101 Vehicle Solution: A-101 Vehicle Solution</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="81"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (19.0)</default_vocab>
        <default_assessment>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="28" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Tympanic Membrane Perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Irritable Bowel Syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application Site Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Food Allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Seasonal Allergy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Ear Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Eye Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Gastroenteritis Viral</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Localised Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="81"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Post Operative Wound Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Salmonellosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="81"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Foot Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood Lactate Dehydrogenase Increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Hepatic Enzyme Increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Liver Function Test Increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Electrolyte Imbalance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Coccydynia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Neck Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Squamous Cell Carcinoma of Head and Neck</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device Dislocation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Ovarian Cyst Ruptured</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Uterine Haemorrage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Oropharyngeal Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis Contact</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Pain of Skin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Skin Exfoliation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Skin Hyperpigmentation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Skin Hypopigmentation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
              </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>Executive Director, Clinical Operations</name_or_title>
      <organization>Aclaris Therapeutics</organization>
      <phone>+1(484) 329-2144</phone>
      <email>jschnyder@aclaristx.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/NCT03278028
org study id: A-101-WART-203
nct id: NCT03278028
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of this study is to evaluate the effectiveness of A-101 compared to
      Vehicle when applied to 1 Target common wart on the trunk or extremities twice a week.
The primary objective of this study is to evaluate the effectiveness of A-101 compared to
      Vehicle when applied to 1 Target common wart on the trunk or extremities twice a week.

      The secondary objectives of this study are to evaluate the clinical effect of A-101 when
      applied to all treated Warts (Target Warts plus Non-Target Warts) twice a week, duration of
      response in all treated Warts (Target Warts plus Non-Target Warts), and safety of A-101.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Physician's Wart Assessment
time frame: Day 57
description: Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated.
Near Clear: A visible wart that is less than 3 mm in maximal diameter (or length)
A visible wart ≥ 3 mm and < 6 mm in maximal diameter (or length)
A visible wart ≥ 6 mm in maximal diameter (or length)
arm group label: Active
arm group type: Experimental
description: A-101 Topical Solutions
arm group label: Vehicle
arm group type: Placebo Comparator
description: Vehicle
intervention type: Drug
intervention name: A-101 Topical Solution
description: A-101 Topical Solution
arm group label: Active
intervention type: Drug
intervention name: A-101 Vehicle Solution
description: A-101 Vehicle Solution
arm group label: Vehicle
criteria: 
gender: All
minimum age: 8 Years
maximum age: N/A
healthy volunteers: No
last name: Stuart D Shanler, MD
role: Study Director
affiliation: Aclaris Therapeutics
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Warts
mesh term: Pharmaceutical Solutions
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 