<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/NCT03292406</url>
  </required_header>
  <id_info>
    <org_study_id>RD.03.SPR.104003</org_study_id>
    <nct_id>NCT03292406</nct_id>
  </id_info>
  <brief_title>A Safety, Efficacy and Pharmacokinetics Study of CD11301 for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)</brief_title>
  <acronym>CTCL</acronym>
  <official_title>A Randomized, Double-blind, Multi-centre, Placebo-controlled, Parallel-arm Phase 2 Trial to Assess Safety, Efficacy and Pharmacokinetics of CD11301 0.03% and 0.06% Gel in the Treatment of Cutaneous T-Cell Lymphoma (CTCL), Stages IA, IB and IIA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Galderma R&amp;D</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Galderma R&amp;D</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To assess the efficacy, safety and pharmacokinetics in participants treated with CD11301 gel&#xD;
      vs. placebo for early stage CTCL (IA, IB, or IIA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To assess the efficacy and safety of two concentrations (0.03% and 0.06%) of CD11301 gel in&#xD;
      the treatment of early stage CTCL (stage IA, IB, or IIA) versus placebo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 19, 2017</start_date>
  <completion_date type="Actual">March 17, 2020</completion_date>
  <primary_completion_date type="Actual">March 17, 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Reported Overall Response (Complete and Partial) of Target Treated Lesions Based on Modified Composite Assessment of Index Lesion Severity (mCAILS) Score at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Overall response is defined as the number of participants that achieved a complete response (CR) or partial response (PR) as assessed by mCAILS. The mCAILS assessment total was derived from components collected on the case report form (CRF). Target treated lesions (1-5 lesions) were rated in erythema (0-8, where 0=no evidence and 8= very severe), scaling (0-8, where 0=no evidence and 8= very severe), plaque elevation (0-3, where 0=no evidence and 3= marked elevation), and size (scale=0-18, where 0= no measurable area and 18= size of lesion &gt;300 centimeter [cm]^2). These 4 ratings were summed to create subtotals, 1 per lesion. The final mCAILS assessment score was the sum of these subtotals. Total summation Score: 0-50 where higher score indicated higher severity. Complete response is defined as a 100% decrease from baseline i.e. score of '0' on the mCAILS scale. Partial response is defined as at least a 50%, but less than 100%, decrease from baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reported Overall Response (OR) of Target Treated Lesions Based on Modified Severity-Weighted Assessment Tool (mSWAT) Score at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>OR is defined as the number of participants that achieved a complete response or partial response as assessed by mSWAT. mSWAT composite score involved the direct assessment of the BSA of each type of lesion (palm plus fingers of the participant= approximately 1% BSA) in each of 12 areas (Head, Neck, Anterior trunk, Arms, Forearms, Hands, Posterior trunk, Buttocks, Thighs, Legs, Feet, Groin) of the body, multiplying the sum of the BSA of each lesion type by a weighting factor (patch = 1, plaque = 2, and tumor = 3 or 4) and generating a sum of the subtotals of each lesion subtype. mSWAT score (0=no lesions; 400= lesions covering all areas). Complete response is defined as a 100% decrease from baseline. Partial response is defined as at least a 50%, but less than 100%, decrease from baseline, and with a tumor subscore of zero (no tumor).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Participant's First Overall Response (Complete or Partial) of the Target Treated Lesions Based on the mCAILS Score</measure>
    <time_frame>Up to Week 36</time_frame>
    <description>Time to overall response (CR or PR) is the number of days from the start of drug application to the first documentation of objective response assessed by mCAILS Score. The 25th, 50th, and 75th percentiles were presented along with 95% confidence intervals using the log-log transformation. The mCAILS assessment total was derived from components collected on the case report form (CRF). Target treated lesions (1-5 lesions) were rated in erythema (0-8, where 0=no evidence and 8= very severe), scaling (0-8, where 0=no evidence and 8= very severe), plaque elevation (0-3, where 0=no evidence and 3= marked elevation), and size (scale=0-18, where 0= no measurable area and 18= size of lesion &gt;300 centimeter [cm]^2). These 4 ratings were summed to create subtotals, 1 per lesion. The final mCAILS assessment score was the sum of these subtotals. Total summation Score: 0-50 where higher score indicated higher severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Overall Response (Complete Response or Partial Response) Based on mCAILS Score</measure>
    <time_frame>Up to Week 36</time_frame>
    <description>The duration of overall response (complete or partial) of the target treated lesions based on the mCAILS score was calculated in days as: (date of first non-response after responding) - (date of response) + 1. The mCAILS assessment total was derived from components collected on the case report form (CRF). Target treated lesions (1-5 lesions) were rated in erythema (0-8, where 0=no evidence and 8= very severe), scaling (0-8, where 0=no evidence and 8= very severe), plaque elevation (0-3, where 0=no evidence and 3= marked elevation), and size (scale=0-18, where 0= no measurable area and 18= size of lesion &gt;300 centimeter [cm]^2). These 4 ratings were summed to create subtotals, 1 per lesion. The final mCAILS assessment score was the sum of these subtotals. Total summation Score: 0-50 where higher score indicated higher severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Progressive Disease Using mSWAT</measure>
    <time_frame>Up to Week 36</time_frame>
    <description>Progressive disease is defined as ≥ 25% increase in skin disease from baseline, or loss of response: in those with CR or PR, increase of skin score of greater than the sum of nadir plus 50% baseline score, Nadir is defined as the lowest skin score (best response).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Skindex-29 Survey Results at Week 12, 24 and 36</measure>
    <time_frame>Week 12, 24 and Follow up (Week 36)</time_frame>
    <description>Participants answered 30 questions as part of the Skindex-29 survey. A composite score and 3 sub scores were calculated from the results. Item 18 of the survey was not used in any scoring. First, answers to each item were given a numeric value: Never = 0; Rarely = 25; Sometimes = 50; Often = 75; All the time = 100. The items used to calculate each subscore were: Emotions: 3, 6, 9, 12, 13, 15, 21, 23, 26, and 28 (10 items), Symptoms: 1, 7, 10, 16, 19, 24, and 27 (7 items), Functioning: 2, 4, 5, 8, 11, 14, 17, 20, 22, 25, 29, and 30 (12 items). The composite score is the average of the 3 sub scores ranging from 0 (no effect)-100 (maximum effect), higher score corresponds to lower quality of life.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">86</enrollment>
  <condition>Cutaneous T Cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>CD11301 Gel 0.06%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants applied 0.06% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CD11301 Gel 0.03%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants applied 0.03% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Non active ingredients of CD11301</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CD11301 0.03%</intervention_name>
    <description>Topical Gel</description>
    <arm_group_label>CD11301 Gel 0.03%</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CD11301 0.06%</intervention_name>
    <description>Topical Gel</description>
    <arm_group_label>CD11301 Gel 0.06%</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical Diagnosis of CTCL stage IA, IB, or IIA with biopsy within last 3 months&#xD;
&#xD;
          -  Have BSA involvement corresponding to stages IA, IB or IIA CTCL with at least 3&#xD;
             distinct lesions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  CTCL that is stage IIB or great or stage IIA with stage N2 with &gt;5% circulating Sezary&#xD;
             cells or CD8+ or large cell transformation or Progressive CTCL&#xD;
&#xD;
          -  History of autoimmune disease&#xD;
&#xD;
          -  Laboratory test values at screening outside of the normal range and judged clinically&#xD;
             significant by the investigator&#xD;
&#xD;
          -  Current participation in another clinical trial of a drug or device or past&#xD;
             participation within 4 weeks before Baseline or participant is in exclusion period&#xD;
             from a previous clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Galderma R&amp;D</last_name>
    <role>Study Director</role>
    <affiliation>Galderma R&amp;D</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Farmington</city>
        <state>Connecticut</state>
        <zip>06032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Pierre-Bénite</city>
        <state>Auvergne-Rhône-Alpes</state>
        <zip>69310</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Nantes</city>
        <state>Pays De La Loire</state>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Paris</city>
        <state>Île-de-France</state>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Mannheim</city>
        <state>Baden-Württemberg</state>
        <zip>68167</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Wurzburg</city>
        <state>Bavaria</state>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Krefeld</city>
        <state>North Rhine-Westphalia</state>
        <zip>47805</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Minden</city>
        <state>North Rhine-Westphalia</state>
        <zip>32429</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Münster</city>
        <state>North Rhine-Westphalia</state>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Kiel</city>
        <state>Schleswig-Holstein</state>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <results_first_submitted>March 12, 2021</results_first_submitted>
  <results_first_submitted_qc>March 12, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 8, 2021</results_first_posted>
  <last_update_submitted>March 12, 2021</last_update_submitted>
  <last_update_submitted_qc>March 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>T-Cell</keyword>
  <keyword>Lymphoma</keyword>
  <keyword>Cutaneous</keyword>
  <keyword>CTCL</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, T-Cell</mesh_term>
    <mesh_term>Lymphoma, T-Cell, Peripheral</mesh_term>
    <mesh_term>Lymphoma, T-Cell, Cutaneous</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No intent to share information.</ipd_description>
  </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>March 25, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT03292406/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>April 23, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT03292406/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study was conducted at 3 countries (France, Germany, USA) between 19 Dec 2017 to 17 Mar 2020. A total of 86 participants were randomized to 1 of the 3 treatment groups (placebo gel or CD11301 gel 0.03% or 0.06%) in a 1:1:1 ratio.</recruitment_details>
      <pre_assignment_details>This study consisted of 2 cycles: Cycle 1 and Cycle 2. Each treatment cycle consisted of 8 weeks on treatment followed by 4 weeks without treatment. Cycle 1: drug product was applied on up to 5 percent (%) body surface area (BSA) and 10% BSA in cycle 2.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>CD11301 Gel 0.06%</title>
          <description>Participants applied 0.06% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.</description>
        </group>
        <group group_id="P2">
          <title>CD11301 Gel 0.03%</title>
          <description>Participants applied 0.03% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Participants applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="28"/>
                <participants group_id="P3" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Participants Treated</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="28"/>
                <participants group_id="P3" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Progressive Disease</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent to treat (ITT) Population included all randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>CD11301 Gel 0.06%</title>
          <description>Participants applied 0.06% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.</description>
        </group>
        <group group_id="B2">
          <title>CD11301 Gel 0.03%</title>
          <description>Participants applied 0.03% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Participants applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
            <count group_id="B2" value="28"/>
            <count group_id="B3" value="28"/>
            <count group_id="B4" value="86"/>
          </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="60.4" spread="14.43"/>
                    <measurement group_id="B2" value="56.8" spread="15.68"/>
                    <measurement group_id="B3" value="61.0" spread="14.21"/>
                    <measurement group_id="B4" value="59.5" spread="14.72"/>
                  </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="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="58"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="82"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </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 group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="79"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Reported Overall Response (Complete and Partial) of Target Treated Lesions Based on Modified Composite Assessment of Index Lesion Severity (mCAILS) Score at Week 12</title>
        <description>Overall response is defined as the number of participants that achieved a complete response (CR) or partial response (PR) as assessed by mCAILS. The mCAILS assessment total was derived from components collected on the case report form (CRF). Target treated lesions (1-5 lesions) were rated in erythema (0-8, where 0=no evidence and 8= very severe), scaling (0-8, where 0=no evidence and 8= very severe), plaque elevation (0-3, where 0=no evidence and 3= marked elevation), and size (scale=0-18, where 0= no measurable area and 18= size of lesion &gt;300 centimeter [cm]^2). These 4 ratings were summed to create subtotals, 1 per lesion. The final mCAILS assessment score was the sum of these subtotals. Total summation Score: 0-50 where higher score indicated higher severity. Complete response is defined as a 100% decrease from baseline i.e. score of '0' on the mCAILS scale. Partial response is defined as at least a 50%, but less than 100%, decrease from baseline.</description>
        <time_frame>Week 12</time_frame>
        <population>ITT Population included all randomized participants. Here, overall number of participants analyzed signifies number of participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>CD11301 Gel 0.06%</title>
            <description>Participants applied 0.06% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>CD11301 Gel 0.03%</title>
            <description>Participants applied 0.03% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reported Overall Response (Complete and Partial) of Target Treated Lesions Based on Modified Composite Assessment of Index Lesion Severity (mCAILS) Score at Week 12</title>
          <description>Overall response is defined as the number of participants that achieved a complete response (CR) or partial response (PR) as assessed by mCAILS. The mCAILS assessment total was derived from components collected on the case report form (CRF). Target treated lesions (1-5 lesions) were rated in erythema (0-8, where 0=no evidence and 8= very severe), scaling (0-8, where 0=no evidence and 8= very severe), plaque elevation (0-3, where 0=no evidence and 3= marked elevation), and size (scale=0-18, where 0= no measurable area and 18= size of lesion &gt;300 centimeter [cm]^2). These 4 ratings were summed to create subtotals, 1 per lesion. The final mCAILS assessment score was the sum of these subtotals. Total summation Score: 0-50 where higher score indicated higher severity. Complete response is defined as a 100% decrease from baseline i.e. score of '0' on the mCAILS scale. Partial response is defined as at least a 50%, but less than 100%, decrease from baseline.</description>
          <population>ITT Population included all randomized participants. Here, overall number of participants analyzed signifies number of participants who were evaluable for this outcome measure.</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="4"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Complete Response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Partial Response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reported Overall Response (OR) of Target Treated Lesions Based on Modified Severity-Weighted Assessment Tool (mSWAT) Score at Week 12</title>
        <description>OR is defined as the number of participants that achieved a complete response or partial response as assessed by mSWAT. mSWAT composite score involved the direct assessment of the BSA of each type of lesion (palm plus fingers of the participant= approximately 1% BSA) in each of 12 areas (Head, Neck, Anterior trunk, Arms, Forearms, Hands, Posterior trunk, Buttocks, Thighs, Legs, Feet, Groin) of the body, multiplying the sum of the BSA of each lesion type by a weighting factor (patch = 1, plaque = 2, and tumor = 3 or 4) and generating a sum of the subtotals of each lesion subtype. mSWAT score (0=no lesions; 400= lesions covering all areas). Complete response is defined as a 100% decrease from baseline. Partial response is defined as at least a 50%, but less than 100%, decrease from baseline, and with a tumor subscore of zero (no tumor).</description>
        <time_frame>Week 12</time_frame>
        <population>ITT Population included all randomized participants. Here, overall number of participants analyzed signifies number of participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>CD11301 Gel 0.06%</title>
            <description>Participants applied 0.06% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>CD11301 Gel 0.03%</title>
            <description>Participants applied 0.03% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reported Overall Response (OR) of Target Treated Lesions Based on Modified Severity-Weighted Assessment Tool (mSWAT) Score at Week 12</title>
          <description>OR is defined as the number of participants that achieved a complete response or partial response as assessed by mSWAT. mSWAT composite score involved the direct assessment of the BSA of each type of lesion (palm plus fingers of the participant= approximately 1% BSA) in each of 12 areas (Head, Neck, Anterior trunk, Arms, Forearms, Hands, Posterior trunk, Buttocks, Thighs, Legs, Feet, Groin) of the body, multiplying the sum of the BSA of each lesion type by a weighting factor (patch = 1, plaque = 2, and tumor = 3 or 4) and generating a sum of the subtotals of each lesion subtype. mSWAT score (0=no lesions; 400= lesions covering all areas). Complete response is defined as a 100% decrease from baseline. Partial response is defined as at least a 50%, but less than 100%, decrease from baseline, and with a tumor subscore of zero (no tumor).</description>
          <population>ITT Population included all randomized participants. Here, overall number of participants analyzed signifies number of participants who were evaluable for this outcome measure.</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="6"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Complete Response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Partial Response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Participant's First Overall Response (Complete or Partial) of the Target Treated Lesions Based on the mCAILS Score</title>
        <description>Time to overall response (CR or PR) is the number of days from the start of drug application to the first documentation of objective response assessed by mCAILS Score. The 25th, 50th, and 75th percentiles were presented along with 95% confidence intervals using the log-log transformation. The mCAILS assessment total was derived from components collected on the case report form (CRF). Target treated lesions (1-5 lesions) were rated in erythema (0-8, where 0=no evidence and 8= very severe), scaling (0-8, where 0=no evidence and 8= very severe), plaque elevation (0-3, where 0=no evidence and 3= marked elevation), and size (scale=0-18, where 0= no measurable area and 18= size of lesion &gt;300 centimeter [cm]^2). These 4 ratings were summed to create subtotals, 1 per lesion. The final mCAILS assessment score was the sum of these subtotals. Total summation Score: 0-50 where higher score indicated higher severity.</description>
        <time_frame>Up to Week 36</time_frame>
        <population>ITT Population included all randomized participants. Here, overall number of participants analyzed signifies number of participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>CD11301 Gel 0.06%</title>
            <description>Participants applied 0.06% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>CD11301 Gel 0.03%</title>
            <description>Participants applied 0.03% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Participant's First Overall Response (Complete or Partial) of the Target Treated Lesions Based on the mCAILS Score</title>
          <description>Time to overall response (CR or PR) is the number of days from the start of drug application to the first documentation of objective response assessed by mCAILS Score. The 25th, 50th, and 75th percentiles were presented along with 95% confidence intervals using the log-log transformation. The mCAILS assessment total was derived from components collected on the case report form (CRF). Target treated lesions (1-5 lesions) were rated in erythema (0-8, where 0=no evidence and 8= very severe), scaling (0-8, where 0=no evidence and 8= very severe), plaque elevation (0-3, where 0=no evidence and 3= marked elevation), and size (scale=0-18, where 0= no measurable area and 18= size of lesion &gt;300 centimeter [cm]^2). These 4 ratings were summed to create subtotals, 1 per lesion. The final mCAILS assessment score was the sum of these subtotals. Total summation Score: 0-50 where higher score indicated higher severity.</description>
          <population>ITT Population included all randomized participants. Here, overall number of participants analyzed signifies number of participants who were evaluable for this outcome measure.</population>
          <units>Days</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>25th (95% CI)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="169" lower_limit="84.0" upper_limit="169.0"/>
                    <measurement group_id="O2" value="85" lower_limit="83.0" upper_limit="174.0"/>
                    <measurement group_id="O3" value="NA" lower_limit="85.0" upper_limit="NA">Missing quartiles and CIs were non-estimable due to a lack of events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50th (95% CI)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="197" lower_limit="169.0" upper_limit="257"/>
                    <measurement group_id="O2" value="NA" lower_limit="169.0" upper_limit="NA">Missing quartiles and CIs were non-estimable due to a lack of events.</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">Missing quartiles and CIs were non-estimable due to a lack of events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>75th (95% CI)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="257" lower_limit="197.0" upper_limit="257"/>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Missing quartiles and CIs were non-estimable due to a lack of events.</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">Missing quartiles and CIs were non-estimable due to a lack of events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Overall Response (Complete Response or Partial Response) Based on mCAILS Score</title>
        <description>The duration of overall response (complete or partial) of the target treated lesions based on the mCAILS score was calculated in days as: (date of first non-response after responding) - (date of response) + 1. The mCAILS assessment total was derived from components collected on the case report form (CRF). Target treated lesions (1-5 lesions) were rated in erythema (0-8, where 0=no evidence and 8= very severe), scaling (0-8, where 0=no evidence and 8= very severe), plaque elevation (0-3, where 0=no evidence and 3= marked elevation), and size (scale=0-18, where 0= no measurable area and 18= size of lesion &gt;300 centimeter [cm]^2). These 4 ratings were summed to create subtotals, 1 per lesion. The final mCAILS assessment score was the sum of these subtotals. Total summation Score: 0-50 where higher score indicated higher severity.</description>
        <time_frame>Up to Week 36</time_frame>
        <population>ITT Population included all randomized participants. Here, overall number of participants analyzed signifies number of participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>CD11301 Gel 0.06%</title>
            <description>Participants applied 0.06% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>CD11301 Gel 0.03%</title>
            <description>Participants applied 0.03% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Overall Response (Complete Response or Partial Response) Based on mCAILS Score</title>
          <description>The duration of overall response (complete or partial) of the target treated lesions based on the mCAILS score was calculated in days as: (date of first non-response after responding) - (date of response) + 1. The mCAILS assessment total was derived from components collected on the case report form (CRF). Target treated lesions (1-5 lesions) were rated in erythema (0-8, where 0=no evidence and 8= very severe), scaling (0-8, where 0=no evidence and 8= very severe), plaque elevation (0-3, where 0=no evidence and 3= marked elevation), and size (scale=0-18, where 0= no measurable area and 18= size of lesion &gt;300 centimeter [cm]^2). These 4 ratings were summed to create subtotals, 1 per lesion. The final mCAILS assessment score was the sum of these subtotals. Total summation Score: 0-50 where higher score indicated higher severity.</description>
          <population>ITT Population included all randomized participants. Here, overall number of participants analyzed signifies number of participants who were evaluable for this outcome measure.</population>
          <units>Days</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>25th (95% CI)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="133" lower_limit="29.0" upper_limit="141.0"/>
                    <measurement group_id="O2" value="NA" lower_limit="38.0" upper_limit="NA">Missing quartiles and CIs were non-estimable due to a lack of events.</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">Missing quartiles and CIs were non-estimable due to a lack of events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50th (95% CI)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="141" lower_limit="133.0" upper_limit="NA">Missing quartiles and CIs were non-estimable due to a lack of events.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="38.0" upper_limit="NA">Missing quartiles and CIs were non-estimable due to a lack of events.</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">Missing quartiles and CIs were non-estimable due to a lack of events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>75th (95% CI)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="133.0" upper_limit="NA">Missing quartiles and CIs were non-estimable due to a lack of events.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Missing quartiles and CIs were non-estimable due to a lack of events.</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">Missing quartiles and CIs were non-estimable due to a lack of events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Progressive Disease Using mSWAT</title>
        <description>Progressive disease is defined as ≥ 25% increase in skin disease from baseline, or loss of response: in those with CR or PR, increase of skin score of greater than the sum of nadir plus 50% baseline score, Nadir is defined as the lowest skin score (best response).</description>
        <time_frame>Up to Week 36</time_frame>
        <population>ITT Population included all randomized participants. Here, overall number of participants analyzed signifies number of participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>CD11301 Gel 0.06%</title>
            <description>Participants applied 0.06% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>CD11301 Gel 0.03%</title>
            <description>Participants applied 0.03% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Progressive Disease Using mSWAT</title>
          <description>Progressive disease is defined as ≥ 25% increase in skin disease from baseline, or loss of response: in those with CR or PR, increase of skin score of greater than the sum of nadir plus 50% baseline score, Nadir is defined as the lowest skin score (best response).</description>
          <population>ITT Population included all randomized participants. Here, overall number of participants analyzed signifies number of participants who were evaluable for this outcome measure.</population>
          <units>Days</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>25th (95% CI)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="170.0" upper_limit="NA">Missing quartiles and CIs were non-estimable due to a lack of events.</measurement>
                    <measurement group_id="O2" value="191" lower_limit="85.0" upper_limit="NA">Missing quartiles and CIs were non-estimable due to a lack of events.</measurement>
                    <measurement group_id="O3" value="93" lower_limit="85.0" upper_limit="93.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50th (95% CI)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Missing quartiles and CIs were non-estimable due to a lack of events.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Missing quartiles and CIs were non-estimable due to a lack of events.</measurement>
                    <measurement group_id="O3" value="93" lower_limit="NA" upper_limit="NA">Missing quartiles and CIs were non-estimable due to a lack of events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>75th (95% CI)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Missing quartiles and CIs were non-estimable due to a lack of events.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Missing quartiles and CIs were non-estimable due to a lack of events.</measurement>
                    <measurement group_id="O3" value="93" lower_limit="NA" upper_limit="NA">Missing quartiles and CIs were non-estimable due to a lack of events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Skindex-29 Survey Results at Week 12, 24 and 36</title>
        <description>Participants answered 30 questions as part of the Skindex-29 survey. A composite score and 3 sub scores were calculated from the results. Item 18 of the survey was not used in any scoring. First, answers to each item were given a numeric value: Never = 0; Rarely = 25; Sometimes = 50; Often = 75; All the time = 100. The items used to calculate each subscore were: Emotions: 3, 6, 9, 12, 13, 15, 21, 23, 26, and 28 (10 items), Symptoms: 1, 7, 10, 16, 19, 24, and 27 (7 items), Functioning: 2, 4, 5, 8, 11, 14, 17, 20, 22, 25, 29, and 30 (12 items). The composite score is the average of the 3 sub scores ranging from 0 (no effect)-100 (maximum effect), higher score corresponds to lower quality of life.</description>
        <time_frame>Week 12, 24 and Follow up (Week 36)</time_frame>
        <population>ITT Population included all randomized participants. Here, overall number of participants analyzed signifies number of participants who were evaluable for this outcome measure and at specific category.</population>
        <group_list>
          <group group_id="O1">
            <title>CD11301 Gel 0.06%</title>
            <description>Participants applied 0.06% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>CD11301 Gel 0.03%</title>
            <description>Participants applied 0.03% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Skindex-29 Survey Results at Week 12, 24 and 36</title>
          <description>Participants answered 30 questions as part of the Skindex-29 survey. A composite score and 3 sub scores were calculated from the results. Item 18 of the survey was not used in any scoring. First, answers to each item were given a numeric value: Never = 0; Rarely = 25; Sometimes = 50; Often = 75; All the time = 100. The items used to calculate each subscore were: Emotions: 3, 6, 9, 12, 13, 15, 21, 23, 26, and 28 (10 items), Symptoms: 1, 7, 10, 16, 19, 24, and 27 (7 items), Functioning: 2, 4, 5, 8, 11, 14, 17, 20, 22, 25, 29, and 30 (12 items). The composite score is the average of the 3 sub scores ranging from 0 (no effect)-100 (maximum effect), higher score corresponds to lower quality of life.</description>
          <population>ITT Population included all randomized participants. Here, overall number of participants analyzed signifies number of participants who were evaluable for this outcome measure and at specific category.</population>
          <units>score on 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="29"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="28"/>
                    <count group_id="O3" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.93" spread="12.408"/>
                    <measurement group_id="O2" value="-0.27" spread="8.583"/>
                    <measurement group_id="O3" value="-1.58" spread="13.243"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.16" spread="11.651"/>
                    <measurement group_id="O2" value="-3.36" spread="9.816"/>
                    <measurement group_id="O3" value="0.58" spread="16.059"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.30" spread="14.838"/>
                    <measurement group_id="O2" value="-3.22" spread="8.340"/>
                    <measurement group_id="O3" value="-0.34" spread="14.081"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From start of the study drug administration up to end of the study (Week 72).</time_frame>
      <desc>Analysis was performed on safety population: randomized participants who applied the study medication at least once.</desc>
      <group_list>
        <group group_id="E1">
          <title>CD11301 Gel 0.06%</title>
          <description>Participants applied 0.06% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.</description>
        </group>
        <group group_id="E2">
          <title>CD11301 Gel 0.03%</title>
          <description>Participants applied 0.03% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Participants applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (20.0)</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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Papillary cystadenoma lymphomatosum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Metastases to bone</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Metastases to central nervous system</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Metastases to muscle</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (20.0)</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="30" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="27" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bundle branch block left</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Atrioventricular block first degree</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application site erosion</sub_title>
                <counts group_id="E1" events="19" subjects_affected="9" subjects_at_risk="30"/>
                <counts group_id="E2" events="6" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Application site ulcer</sub_title>
                <counts group_id="E1" events="19" subjects_affected="8" subjects_at_risk="30"/>
                <counts group_id="E2" events="13" subjects_affected="8" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Application site erythema</sub_title>
                <counts group_id="E1" events="15" subjects_affected="7" subjects_at_risk="30"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="28"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Application site pain</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Application site pruritus</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" events="12" subjects_affected="8" subjects_at_risk="28"/>
                <counts group_id="E3" events="7" subjects_affected="4" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Application site dermatitis</sub_title>
                <counts group_id="E1" events="16" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" events="9" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Application site rash</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" events="5" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="6" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Application site irritation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="15" subjects_affected="5" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Application site eczema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Application site inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="16" subjects_affected="6" subjects_at_risk="28"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="8" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Fungal skin infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Urine leukocyte esterase positive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Mycosis fungoides</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" events="7" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="13" subjects_affected="7" subjects_at_risk="30"/>
                <counts group_id="E2" events="8" subjects_affected="5" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin erosion</sub_title>
                <counts group_id="E1" events="9" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E2" events="8" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="10" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="6" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Papule</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="5" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Operations</name_or_title>
      <organization>Galderma</organization>
      <phone>817 961 5000 ext 1</phone>
      <email>Clinical.Studies@galderma.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03292406
org study id: RD.03.SPR.104003
nct id: NCT03292406
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
To assess the efficacy, safety and pharmacokinetics in participants treated with CD11301 gel
      vs. placebo for early stage CTCL (IA, IB, or IIA).
To assess the efficacy and safety of two concentrations (0.03% and 0.06%) of CD11301 gel in
      the treatment of early stage CTCL (stage IA, IB, or IIA) versus placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants Reported Overall Response (Complete and Partial) of Target Treated Lesions Based on Modified Composite Assessment of Index Lesion Severity (mCAILS) Score at Week 12
time frame: Week 12
description: Overall response is defined as the number of participants that achieved a complete response (CR) or partial response (PR) as assessed by mCAILS. The mCAILS assessment total was derived from components collected on the case report form (CRF). Target treated lesions (1-5 lesions) were rated in erythema (0-8, where 0=no evidence and 8= very severe), scaling (0-8, where 0=no evidence and 8= very severe), plaque elevation (0-3, where 0=no evidence and 3= marked elevation), and size (scale=0-18, where 0= no measurable area and 18= size of lesion >300 centimeter [cm]^2). These 4 ratings were summed to create subtotals, 1 per lesion. The final mCAILS assessment score was the sum of these subtotals. Total summation Score: 0-50 where higher score indicated higher severity. Complete response is defined as a 100% decrease from baseline i.e. score of '0' on the mCAILS scale. Partial response is defined as at least a 50%, but less than 100%, decrease from baseline.
measure: Number of Participants Reported Overall Response (OR) of Target Treated Lesions Based on Modified Severity-Weighted Assessment Tool (mSWAT) Score at Week 12
time frame: Week 12
description: OR is defined as the number of participants that achieved a complete response or partial response as assessed by mSWAT. mSWAT composite score involved the direct assessment of the BSA of each type of lesion (palm plus fingers of the participant= approximately 1% BSA) in each of 12 areas (Head, Neck, Anterior trunk, Arms, Forearms, Hands, Posterior trunk, Buttocks, Thighs, Legs, Feet, Groin) of the body, multiplying the sum of the BSA of each lesion type by a weighting factor (patch = 1, plaque = 2, and tumor = 3 or 4) and generating a sum of the subtotals of each lesion subtype. mSWAT score (0=no lesions; 400= lesions covering all areas). Complete response is defined as a 100% decrease from baseline. Partial response is defined as at least a 50%, but less than 100%, decrease from baseline, and with a tumor subscore of zero (no tumor).
measure: Time to Participant's First Overall Response (Complete or Partial) of the Target Treated Lesions Based on the mCAILS Score
time frame: Up to Week 36
description: Time to overall response (CR or PR) is the number of days from the start of drug application to the first documentation of objective response assessed by mCAILS Score. The 25th, 50th, and 75th percentiles were presented along with 95% confidence intervals using the log-log transformation. The mCAILS assessment total was derived from components collected on the case report form (CRF). Target treated lesions (1-5 lesions) were rated in erythema (0-8, where 0=no evidence and 8= very severe), scaling (0-8, where 0=no evidence and 8= very severe), plaque elevation (0-3, where 0=no evidence and 3= marked elevation), and size (scale=0-18, where 0= no measurable area and 18= size of lesion >300 centimeter [cm]^2). These 4 ratings were summed to create subtotals, 1 per lesion. The final mCAILS assessment score was the sum of these subtotals. Total summation Score: 0-50 where higher score indicated higher severity.
measure: Duration of Overall Response (Complete Response or Partial Response) Based on mCAILS Score
time frame: Up to Week 36
description: The duration of overall response (complete or partial) of the target treated lesions based on the mCAILS score was calculated in days as: (date of first non-response after responding) - (date of response) + 1. The mCAILS assessment total was derived from components collected on the case report form (CRF). Target treated lesions (1-5 lesions) were rated in erythema (0-8, where 0=no evidence and 8= very severe), scaling (0-8, where 0=no evidence and 8= very severe), plaque elevation (0-3, where 0=no evidence and 3= marked elevation), and size (scale=0-18, where 0= no measurable area and 18= size of lesion >300 centimeter [cm]^2). These 4 ratings were summed to create subtotals, 1 per lesion. The final mCAILS assessment score was the sum of these subtotals. Total summation Score: 0-50 where higher score indicated higher severity.
measure: Time to Progressive Disease Using mSWAT
time frame: Up to Week 36
description: Progressive disease is defined as ≥ 25% increase in skin disease from baseline, or loss of response: in those with CR or PR, increase of skin score of greater than the sum of nadir plus 50% baseline score, Nadir is defined as the lowest skin score (best response).
measure: Change From Baseline in Skindex-29 Survey Results at Week 12, 24 and 36
time frame: Week 12, 24 and Follow up (Week 36)
description: Participants answered 30 questions as part of the Skindex-29 survey. A composite score and 3 sub scores were calculated from the results. Item 18 of the survey was not used in any scoring. First, answers to each item were given a numeric value: Never = 0; Rarely = 25; Sometimes = 50; Often = 75; All the time = 100. The items used to calculate each subscore were: Emotions: 3, 6, 9, 12, 13, 15, 21, 23, 26, and 28 (10 items), Symptoms: 1, 7, 10, 16, 19, 24, and 27 (7 items), Functioning: 2, 4, 5, 8, 11, 14, 17, 20, 22, 25, 29, and 30 (12 items). The composite score is the average of the 3 sub scores ranging from 0 (no effect)-100 (maximum effect), higher score corresponds to lower quality of life.
arm group label: CD11301 Gel 0.06%
arm group type: Experimental
description: Participants applied 0.06% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.
arm group label: CD11301 Gel 0.03%
arm group type: Experimental
description: Participants applied 0.03% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.
arm group label: Placebo
arm group type: Experimental
description: Participants applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks.
intervention type: Drug
intervention name: Placebo
description: Non active ingredients of CD11301
arm group label: Placebo
intervention type: Drug
intervention name: CD11301 0.03%
description: Topical Gel
arm group label: CD11301 Gel 0.03%
arm group label: Placebo
intervention type: Drug
intervention name: CD11301 0.06%
description: Topical Gel
arm group label: CD11301 Gel 0.06%
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Galderma R&D
role: Study Director
affiliation: Galderma R&D
facility: 
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country: France
country: Germany
country: United States
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, T-Cell
mesh term: Lymphoma, T-Cell, Peripheral
mesh term: Lymphoma, T-Cell, Cutaneous
sharing ipd: No
ipd description: No intent to share information.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 