<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/NCT03824405</url>
  </required_header>
  <id_info>
    <org_study_id>BTX.2018.003</org_study_id>
    <nct_id>NCT03824405</nct_id>
  </id_info>
  <brief_title>Study of the Safety, Tolerability and Efficacy of BTX 1204 in Patients With Moderate Atopic Dermatitis</brief_title>
  <official_title>A Randomized, Double-Blind, Vehicle-Controlled Study of the Safety, Tolerability and Efficacy of BTX 1204 in Patients With Moderate Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Botanix Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Botanix Pharmaceuticals</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>
      This is a randomized, double-blind, vehicle-controlled, Phase 2 study in subjects with&#xD;
      moderate AD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, double-blind, vehicle-controlled, Phase 2 study in subjects with&#xD;
      moderate AD. Eligible subjects will be enrolled and randomized to treatment with BTX 1204 or&#xD;
      Vehicle for 84 days. Approximately two hundred (200) subjects will be enrolled. Subjects will&#xD;
      receive BID application of study drug for 84 days with a final application on the evening of&#xD;
      Day 84 for a total of 168 doses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 4, 2019</start_date>
  <completion_date type="Actual">March 4, 2020</completion_date>
  <primary_completion_date type="Actual">January 27, 2020</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Investigator's Global Assessment (IGA)</measure>
    <time_frame>Day 85</time_frame>
    <description>Investigator's Global Assessment (IGA) success defined as an IGA score of &quot;Clear&quot; (0) or &quot;Almost Clear&quot; (1) with at least a 2-grade improvement</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>BTX 1204</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>BTX 1204 twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Vehicle twice daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BTX 1204</intervention_name>
    <description>BTX 1204 liquid formulation</description>
    <arm_group_label>BTX 1204</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vehicle</intervention_name>
    <description>Vehicle liquid formulation</description>
    <arm_group_label>Vehicle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is of either gender between 12 and 70 years of age, inclusive.&#xD;
&#xD;
          2. Subject (or parent/legal guardian) has the ability and willingness to sign a written&#xD;
             informed consent.&#xD;
&#xD;
          3. Subject has a diagnosis of chronic (≥1 year), stable atopic dermatitis (AD)&#xD;
&#xD;
          4. Subject has ≥ 5% and ≤ 30% body surface area (BSA) of AD involvement excluding the&#xD;
             scalp and groin.&#xD;
&#xD;
          5. Subject has an Investigator's Global Assessment (IGA) score of moderate (3) atopic&#xD;
             dermatitis on the 5-point IGA (0-4) scale.&#xD;
&#xD;
          6. For selected photography sites, subject has a target lesion of 25 to 200 cm2 in&#xD;
             surface area on the trunk, upper extremities or lower extremities with a Baseline&#xD;
             Signs of AD score of ≥ 6 and ≤ 12.&#xD;
&#xD;
          7. Subject is in good general health without clinically significant hematological,&#xD;
             cardiac, respiratory, renal, endocrine, gastrointestinal, psychiatric, hepatic, or&#xD;
             malignant disease, as determined by the investigator.&#xD;
&#xD;
          8. Subject has suitable venous access for blood sampling.&#xD;
&#xD;
          9. Subject is able and willing to complete the study and to comply with all study&#xD;
             instructions and attend the necessary visits.&#xD;
&#xD;
         10. Male subjects and their partners must agree and commit to use a barrier method of&#xD;
             contraception throughout the study and for 90 days after last study drug application.&#xD;
&#xD;
         11. A negative urine pregnancy test result for all Women of child bearing potential&#xD;
             (WOCBP) at the Screening Visit and Baseline Visit.&#xD;
&#xD;
         12. Sexually active women must agree to use the following throughout the study and for 30&#xD;
             days after last study drug application. WOCBP who are not sexually active at Baseline&#xD;
             and become sexually active must identify a plan for contraception.&#xD;
&#xD;
               1. One of these highly effective contraception methods Intrauterine device (IUD);&#xD;
                  hormonal (injections, implants, transdermal patch, vaginal ring); tubal ligation;&#xD;
                  partner vasectomy, OR&#xD;
&#xD;
               2. Oral contraceptives WITH a barrier method (listed below), OR&#xD;
&#xD;
               3. Two barrier forms of contraception (listed below) Male or female condom;&#xD;
                  diaphragm; cervical cap; contraceptive sponge.&#xD;
&#xD;
         13. Males subjects must refrain from sperm donation during the study treatment period and&#xD;
             until 90 days after last study drug application.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Female subject who is breast feeding, pregnant, or planning to become pregnant.&#xD;
&#xD;
          2. Subject who has an IGA score of 2 (mild) or 4 (severe).&#xD;
&#xD;
          3. Subject with history of known or suspected intolerance to the drug product excipients.&#xD;
&#xD;
          4. Subject has any clinically significant active infection in the investigator's opinion.&#xD;
             This includes active impetigo at any AD lesion.&#xD;
&#xD;
          5. Subject has known Hepatitis-B, Hepatitis-C, or HIV infection.&#xD;
&#xD;
          6. Subject has excessive body or facial hair that would interfere with the evaluation of&#xD;
             safety or with the diagnosis or assessment of AD.&#xD;
&#xD;
          7. Subject has sunburns, unevenness in skin tones, tattoos, scars, excessive hair,&#xD;
             freckles, birthmarks, moles, or other skin damage or abnormality that would result in&#xD;
             the inability to evaluate the AD lesions.&#xD;
&#xD;
          8. Subject has clinically significant or severe allergies that in the investigator's&#xD;
             opinion would interfere with participation in the study.&#xD;
&#xD;
          9. Subject has known intolerability to topical treatments e.g., reports excessive&#xD;
             burning/stinging or pain with use of topical treatments.&#xD;
&#xD;
         10. Subject has an active or potentially recurring skin conditions(s) other than AD that&#xD;
             in the investigator's opinion would interfere with participation in the study.&#xD;
&#xD;
         11. Subject has unstable AD consistent with a requirement for high-potency&#xD;
             corticosteroids.&#xD;
&#xD;
         12. Subject has used dupilumab (Dupixent) within 12 weeks prior to the Baseline Visit.&#xD;
&#xD;
         13. Subject has used any biologic therapy, other than dupilumab, within 28 days prior to&#xD;
             the Baseline Visit.&#xD;
&#xD;
         14. Subject has used systemic (oral, IV or IM) corticosteroids within 28 days prior to the&#xD;
             Baseline Visit. Intra-articular injection for arthroses allowed.&#xD;
&#xD;
         15. Subject has used topical anti-pruritics (e.g., PDE4 inhibitors) within 28 days prior&#xD;
             to the Baseline Visit.&#xD;
&#xD;
         16. If subject is taking oral antihistamines, subject has not been on a stable dose of&#xD;
             oral antihistamines within 28 days prior to the Baseline visit.&#xD;
&#xD;
         17. Subject has used phototherapy, tanning beds, or any other artificial light device&#xD;
             within 28 days prior to the Baseline Visit.&#xD;
&#xD;
         18. Subject has used topical corticosteroids within 14 days prior to the Baseline Visit.&#xD;
&#xD;
         19. Subject has used topical calcineurin inhibitors within 14 days prior to the Baseline&#xD;
             Visit.&#xD;
&#xD;
         20. Subjects has used barrier creams (e.g., Mimyx, Atopiclair), within 7 days prior to the&#xD;
             Baseline Visit.&#xD;
&#xD;
         21. Subject has an underlying disease that requires the use of interfering topical or&#xD;
             systemic therapy.&#xD;
&#xD;
         22. Subject has other dermatological conditions that require the use of interfering&#xD;
             topical or systemic therapy or that might interfere with study assessments such as,&#xD;
             but not limited to, acne or rosacea.&#xD;
&#xD;
         23. Subject has a clinically relevant history or currently suffering from any disease or&#xD;
             condition that, in the opinion of the investigator, may affect the evaluation of the&#xD;
             study product or place the subject at undue risk or interfere with the subject's&#xD;
             participation in the study. Subjects with other dermatologic conditions, including&#xD;
             genetic syndromes that have an eczematous dermatitis as a component of the disease&#xD;
             (e.g., Netherton's) are excluded.&#xD;
&#xD;
         24. Subject has a clinically relevant history of or current evidence of abuse of alcohol&#xD;
             or other drugs.&#xD;
&#xD;
         25. Subject is currently using any medication that, in the opinion of the investigator,&#xD;
             may affect the evaluation of the study product or place the subject at undue risk.&#xD;
&#xD;
         26. Subject has participated in another investigational drug or device research study&#xD;
             within 30 days of the Screening Visit or five half-lives of the drug, whichever is&#xD;
             longer.&#xD;
&#xD;
         27. Any other reason that would make the subject, in the opinion of the Investigator or&#xD;
             sponsor, unsuitable for the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anthony Robinson, CRNP</last_name>
    <role>Study Director</role>
    <affiliation>Head of Development, Botanix Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Applied Research Center of Arkansas Inc.</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>T. Joseph Raoff MD Inc. / Encino Research Center</name>
      <address>
        <city>Encino</city>
        <state>California</state>
        <zip>91436</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Dermatology Clinical Research</name>
      <address>
        <city>Fremont</city>
        <state>California</state>
        <zip>94538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Specialist Inc. - Murrieta</name>
      <address>
        <city>Murrieta</city>
        <state>California</state>
        <zip>92562</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rady Childern's Hospital - San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Science Institute</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Precision Clinical Research</name>
      <address>
        <city>Davie</city>
        <state>Florida</state>
        <zip>33328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Troy Sullivan</name>
      <address>
        <city>North Miami Beach</city>
        <state>Florida</state>
        <zip>33162</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Research</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delright Research</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisearch Clinical Trails</name>
      <address>
        <city>Saint Joseph</city>
        <state>Missouri</state>
        <zip>64506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington Univerisy in St. Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JDR Dermatology Research LLC</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Acne Treatment and Research Center</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aventiv Research Inc - Dublin</name>
      <address>
        <city>Dublin</city>
        <state>Ohio</state>
        <zip>43016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greenville Dermatology, LLC</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermresearch Inc</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78759</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>J&amp;S Studies Inc.</name>
      <address>
        <city>College Station</city>
        <state>Texas</state>
        <zip>77845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Center for Skin Research at Suzanne Bruce &amp; Associates Dermatology</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CMAX Clincial Research</name>
      <address>
        <city>Adelaide</city>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BurwoodDermatology</name>
      <address>
        <city>Burwood</city>
        <zip>6100</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sinclair Dermatology</name>
      <address>
        <city>East Melbourne</city>
        <zip>3002</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Eastern Health Specialists</name>
      <address>
        <city>Hectorville</city>
        <zip>5073</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Specialists PTY LTD</name>
      <address>
        <city>Kogarah</city>
        <zip>2217</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St George Dermatology &amp; Skin Cancer Center</name>
      <address>
        <city>Kogarah</city>
        <zip>2217</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Captain Stirling Medical Centre</name>
      <address>
        <city>Nedlands</city>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Skin Hospital</name>
      <address>
        <city>Westmead</city>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veracity Clinical Research</name>
      <address>
        <city>Woolloongabba</city>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Optimal Clinical Trials</name>
      <address>
        <city>Auckland</city>
        <zip>1010</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials New Zealand LTD</name>
      <address>
        <city>Hamilton</city>
        <zip>3204</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>P3 Research</name>
      <address>
        <city>Wellington</city>
        <zip>6021</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>New Zealand</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <results_first_submitted>August 31, 2022</results_first_submitted>
  <results_first_submitted_qc>August 31, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 27, 2022</results_first_posted>
  <last_update_submitted>September 30, 2022</last_update_submitted>
  <last_update_submitted_qc>September 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CBD</keyword>
  <keyword>Synthetic CBD</keyword>
  <keyword>Cannabidiol</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>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>August 21, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT03824405/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 13, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT03824405/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>BTX 1204</title>
          <description>BTX 1204 twice daily&#xD;
BTX 1204: BTX 1204 liquid formulation</description>
        </group>
        <group group_id="P2">
          <title>Vehicle</title>
          <description>Vehicle twice daily&#xD;
Vehicle: Vehicle liquid formulation</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent-to-treat Population</population>
      <group_list>
        <group group_id="B1">
          <title>BTX 1204</title>
          <description>BTX 1204 twice daily&#xD;
BTX 1204: BTX 1204 liquid formulation</description>
        </group>
        <group group_id="B2">
          <title>Vehicle</title>
          <description>Vehicle twice daily&#xD;
Vehicle: Vehicle liquid formulation</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="99"/>
            <count group_id="B2" value="95"/>
            <count group_id="B3" value="194"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="153"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </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="62"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="116"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="78"/>
                  </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="9"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="90"/>
                    <measurement group_id="B2" value="84"/>
                    <measurement group_id="B3" value="174"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="108"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="14"/>
                  </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>Investigator Global Assessment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0 - Clear</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>1 - Almost Clear</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>2 - Mild</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>3 - Moderate</title>
                  <measurement_list>
                    <measurement group_id="B1" value="99"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="194"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4 - Severe</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>Investigator's Global Assessment (IGA)</title>
        <description>Investigator's Global Assessment (IGA) success defined as an IGA score of &quot;Clear&quot; (0) or &quot;Almost Clear&quot; (1) with at least a 2-grade improvement</description>
        <time_frame>Day 85</time_frame>
        <population>ITT Summary of Subjects Excluded From Analyses (Randomized Subjects) BTX 1204 4% BID (N=100) Vehicle BID (N=100)&#xD;
Number of Subjects Excluded from the ITT Population, n (%) BTX 1204 4% BID 1 (1.0) Vehicle BID 5 (5.0)&#xD;
Reason for Exclusion from the ITT Population, n (%) Not At Least One Post-Baseline Efficacy Assessment BTX 1204 4% BID 1 (1.0) Vehicle BID 5 (5.0)</population>
        <group_list>
          <group group_id="O1">
            <title>BTX 1204</title>
            <description>BTX 1204 twice daily&#xD;
BTX 1204: BTX 1204 liquid formulation</description>
          </group>
          <group group_id="O2">
            <title>Vehicle</title>
            <description>Vehicle twice daily&#xD;
Vehicle: Vehicle liquid formulation</description>
          </group>
        </group_list>
        <measure>
          <title>Investigator's Global Assessment (IGA)</title>
          <description>Investigator's Global Assessment (IGA) success defined as an IGA score of &quot;Clear&quot; (0) or &quot;Almost Clear&quot; (1) with at least a 2-grade improvement</description>
          <population>ITT Summary of Subjects Excluded From Analyses (Randomized Subjects) BTX 1204 4% BID (N=100) Vehicle BID (N=100)&#xD;
Number of Subjects Excluded from the ITT Population, n (%) BTX 1204 4% BID 1 (1.0) Vehicle BID 5 (5.0)&#xD;
Reason for Exclusion from the ITT Population, n (%) Not At Least One Post-Baseline Efficacy Assessment BTX 1204 4% BID 1 (1.0) Vehicle BID 5 (5.0)</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="99"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Success</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Failure</title>
                  <measurement_list>
                    <measurement group_id="O1" value="87"/>
                    <measurement group_id="O2" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>85 days</time_frame>
      <desc>Summary of Subjects Excluded From Analyses (Randomized Subjects) BTX 1204 4% BID (N=100) Vehicle BID (N=100)&#xD;
Number of Subjects Excluded from the Safety Population, n (%) BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0)&#xD;
Reason for Exclusion from the Safety Population, n (%) No Post-Baseline Safety Assessment BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0)</desc>
      <group_list>
        <group group_id="E1">
          <title>BTX 1204</title>
          <description>BTX 1204 twice daily&#xD;
BTX 1204: BTX 1204 liquid formulation</description>
        </group>
        <group group_id="E2">
          <title>Vehicle</title>
          <description>Vehicle twice daily&#xD;
Vehicle: Vehicle liquid formulation</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (22.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="99"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="99"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Post-procedural complication</sub_title>
                <description>Outcome: Recovered/resolved Severity: Severe Causality: Unrelated Study Drug Action Taken: None</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="99"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <description>Outcome: Recovered/resolved Causality: Unrelated Study Drug Action Taken: Not Applicable</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="99"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA (22.0)</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="37" subjects_at_risk="99"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis atopic</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="99"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="99"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="99"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Application Site Pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="99"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Pruritis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="99"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Application Site Reaction</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="99"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Dry Skin</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="99"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="98"/>
              </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>As Study is a Multi-centre Study, no Publication of the Study results may be made until Publication of the results of the Multi-centre study or 2 years after Study Completion, whichever is sooner.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Head of Development</name_or_title>
      <organization>Botanix Pharmaceuticals</organization>
      <phone>+1 (445) 300-3403</phone>
      <email>trials@botanixpharma.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/NCT03824405
org study id: BTX.2018.003
nct id: NCT03824405
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, double-blind, vehicle-controlled, Phase 2 study in subjects with
      moderate AD.
This is a randomized, double-blind, vehicle-controlled, Phase 2 study in subjects with
      moderate AD. Eligible subjects will be enrolled and randomized to treatment with BTX 1204 or
      Vehicle for 84 days. Approximately two hundred (200) subjects will be enrolled. Subjects will
      receive BID application of study drug for 84 days with a final application on the evening of
      Day 84 for a total of 168 doses.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Investigator's Global Assessment (IGA)
time frame: Day 85
description: Investigator's Global Assessment (IGA) success defined as an IGA score of "Clear" (0) or "Almost Clear" (1) with at least a 2-grade improvement
arm group label: BTX 1204
arm group type: Active Comparator
description: BTX 1204 twice daily
arm group label: Vehicle
arm group type: Placebo Comparator
description: Vehicle twice daily
intervention type: Drug
intervention name: BTX 1204
description: BTX 1204 liquid formulation
arm group label: BTX 1204
intervention type: Drug
intervention name: Vehicle
description: Vehicle liquid formulation
arm group label: Vehicle
criteria: 
gender: All
minimum age: 12 Years
maximum age: 70 Years
healthy volunteers: No
last name: Anthony Robinson, CRNP
role: Study Director
affiliation: Head of Development, Botanix Pharmaceuticals
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: New Zealand
country: United States
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 