<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/NCT03806790</url>
  </required_header>
  <id_info>
    <org_study_id>LP0053-1422</org_study_id>
    <nct_id>NCT03806790</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of LEO 90100 Foam in Japanese Subjects With Psoriasis Vulgaris</brief_title>
  <official_title>Efficacy and Safety of LEO 90100 Foam in Japanese Subjects With Psoriasis Vulgaris</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LEO Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LEO Pharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparison of the efficacy of LEO 90100 foam with Dovobet® ointment in the treatment of&#xD;
      psoriasis in Japanese subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A phase 3, national, multi-centre, 4-week, prospective, randomised, controlled,&#xD;
      parallel-group, open trial of LEO 90100 foam versus Dovobet® ointment (both treatments&#xD;
      containing calcipotriol hydrate plus betamethasone dipropionate) in Japanese subjects with&#xD;
      psoriasis vulgaris.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 24, 2019</start_date>
  <completion_date type="Actual">June 10, 2019</completion_date>
  <primary_completion_date type="Actual">June 10, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Improvement Rate for the Target Lesion</measure>
    <time_frame>End of Week 4</time_frame>
    <description>Overall improvement defined as 'Substantial Resolution' of Clinical Signs or at Least 'Moderately Improved' in the General Change in the Lesion.&#xD;
Substantial resolution' is defined as a clinical score for thickness and scaliness of 0 and a clinical score for redness of 1 or less in the severity of clinical signs of the target lesion. The details of the clinical scores are presented in secondary outcome measure description for 'Change in the total sign score'.&#xD;
Change in the Lesion is a 5 point scale below:&#xD;
Markedly improved (best outcome)&#xD;
Moderately improved&#xD;
Slightly improved&#xD;
Unchanged&#xD;
Aggravated (worst outcome)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Improvement Rate for the Target Lesion at Weeks 1 and 2</measure>
    <time_frame>End of Weeks 1 and 2</time_frame>
    <description>Substantial resolution of clinical signs or at least 'moderately improved' in the general change in the target lesion.&#xD;
Change in the Lesion is a 5 point scale below:&#xD;
Markedly improved (best outcome)&#xD;
Moderately improved&#xD;
Slightly improved&#xD;
Unchanged&#xD;
Aggravated (worst outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Total Sign Score for the Target Lesion From Week 0 to Week 4</measure>
    <time_frame>End of Week 4</time_frame>
    <description>The change in the total sign score from Week 0 to Week 4; total sign score is defined as the sum of the scores from the 3 clinical signs (redness, thickness, and scaliness) assessing severity in the target lesion.&#xD;
The severity for each of the 3 clinical signs was recorded according to a 9-point scale that ranges from a score of 0 to 4 in increments of 0.5; the severities are scored from low to high with 0 = none and 4 = severe. The sum of the 3 total sign scores could range from 0 (best) to 12 (worse). The greater the negative value for the change means a better outcome.&#xD;
Negative change denotes a decrease in the score and therefore a decrease in disease severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Adverse Events</measure>
    <time_frame>Treatment Emergent Adverse Events were assessed from Day 1 to end of Week 4, if Treatment Emergent Adverse Events were noted, they were followed for an additional 14 days</time_frame>
    <description>Number of treatment emergent adverse events (TEAEs). 14-day follow-up of TEAEs was only required if the TEAE was present at the last visit, and was of possible or probable relationship to trial medication.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">182</enrollment>
  <condition>Psoriasis Vulgaris</condition>
  <arm_group>
    <arm_group_label>LEO 90100 foam</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dovobet® ointment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LEO 90100 foam</intervention_name>
    <description>Once daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion.</description>
    <arm_group_label>LEO 90100 foam</arm_group_label>
    <other_name>Enstilar® Foam</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dovobet® ointment</intervention_name>
    <description>Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion.</description>
    <arm_group_label>Dovobet® ointment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          1. Signed and dated informed consent obtained&#xD;
&#xD;
          2. Japanese subjects&#xD;
&#xD;
          3. Aged 20 years or above&#xD;
&#xD;
          4. Clinical diagnosis of psoriasis vulgaris amenable to topical treatment of less than or&#xD;
             equal to 30% BSA (excluding psoriasis on the face/genitals/skin folds).&#xD;
&#xD;
          5. A target psoriasis lesion of at least mild severity on the body of a minimum size of&#xD;
             10 cm2 and scoring at least 2 (mild) for each of the clinical signs). The lesion must&#xD;
             not be on the scalp, face, genitals or skin folds.&#xD;
&#xD;
          6. Women of childbearing potential must have a negative pregnancy test at Day 1 and agree&#xD;
             to use an adequate methods of birth control during the trial.&#xD;
&#xD;
          7. Able to communicate with the (sub)investigator and understand and comply with the&#xD;
             requirements of the trial.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. Systemic use of biological treatments with a potential effect on psoriasis vulgaris&#xD;
             within the specified time periods prior to randomisation (depending on treatment)&#xD;
&#xD;
          2. Systemic treatments with all therapies other than biological treatments with a&#xD;
             potential effect on psoriasis vulgaris within 4 weeks prior to randomisation&#xD;
&#xD;
          3. PUVA therapy, UVB therapy or UVA therapy on the full body or on the target lesion&#xD;
             within 4 weeks prior to randomisation&#xD;
&#xD;
          4. Topical treatment of psoriasis on the areas to be treated with trial medication within&#xD;
             2 weeks prior to randomisation&#xD;
&#xD;
          5. Topical treatment of psoriasis on the face, genitals or skin folds with vitamin D3&#xD;
             analogues, potent corticosteroids or immunosuppressants within 2 weeks prior to&#xD;
             randomisation&#xD;
&#xD;
          6. Topical treatment of conditions other than psoriasis with vitamin D3 analogues, potent&#xD;
             corticosteroids or immunosuppressants within 2 weeks prior to randomisation&#xD;
&#xD;
          7. Initiation or changes of medication that may affect psoriasis vulgaris during the&#xD;
             trial&#xD;
&#xD;
          8. Patients with certain disorders or symptoms present on the areas to be treated with&#xD;
             trial medication: viral lesions of the skin, infections, skin manifestations, or&#xD;
             fragility of skin veins&#xD;
&#xD;
          9. Other inflammatory skin diseases that may confound the evaluation of psoriasis&#xD;
             vulgaris&#xD;
&#xD;
         10. Erythrodermic, exfoliative or pustular psoriasis on the areas to be treated with trial&#xD;
             medication&#xD;
&#xD;
         11. Planned excessive exposure of areas to be treated with trial medication to either&#xD;
             natural or artificial sunlight during the trial.&#xD;
&#xD;
         12. Disorders of calcium metabolism&#xD;
&#xD;
         13. Severe renal insufficiency, severe hepatic disorders or severe heart disease&#xD;
&#xD;
         14. Hypersensitivity to any components of the investigational medicinal products.&#xD;
&#xD;
         15. Cushing's disease or Addison's disease&#xD;
&#xD;
         16. Subjects who have received treatment with any non-marketed drug substance within the 4&#xD;
             weeks prior to randomisation, or longer if for certain biological treatments&#xD;
&#xD;
         17. History of cancer within the last 5 years (except completely cured skin cancer)&#xD;
&#xD;
         18. Current participation in any other interventional clinical trial&#xD;
&#xD;
         19. Previously randomised in this trial&#xD;
&#xD;
         20. Women who are pregnant, wishing to become pregnant or are breast-feeding&#xD;
&#xD;
         21. Chronic alcohol or drug abuse within 12 months prior to screening, or any condition&#xD;
             associated with poor compliance&#xD;
&#xD;
         22. Employees of the trial site or any other individuals directly involved with the&#xD;
             planning or conduct of the trial, or immediate family members of such individuals&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Expert</last_name>
    <role>Study Director</role>
    <affiliation>LEO Pharma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Leo Pharma Investigational Site</name>
      <address>
        <city>Fukutsu</city>
        <state>Fukuoka</state>
        <zip>811-3217</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigational Site</name>
      <address>
        <city>Obihiro</city>
        <state>Hokkaido</state>
        <zip>080-0013</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigational Site</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <zip>004-0063</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigational Site</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <zip>006-0814</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigational Site</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <zip>060-0807</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigational Site</name>
      <address>
        <city>Nonoichi</city>
        <state>Ishikawa</state>
        <zip>921-8801</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigational Site</name>
      <address>
        <city>Kawasaki</city>
        <state>Kanagawa</state>
        <zip>213-0001</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigational Site</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>220-6208</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigational Site</name>
      <address>
        <city>Sendai</city>
        <state>Miyagi</state>
        <zip>981-3133</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigational Site</name>
      <address>
        <city>Saitama-shi</city>
        <state>Saitama</state>
        <zip>330-0854</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigational Site</name>
      <address>
        <city>Itabashi-ku</city>
        <state>Tokyo</state>
        <zip>173-8605</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigational Site</name>
      <address>
        <city>Kita-ku</city>
        <state>Tokyo</state>
        <zip>115-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigational Site</name>
      <address>
        <city>Koto-Ku</city>
        <state>Tokyo</state>
        <zip>136-0074</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigational Site</name>
      <address>
        <city>Minato-Ku</city>
        <state>Tokyo</state>
        <zip>108-0014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigational Site</name>
      <address>
        <city>Setagaya</city>
        <state>Tokyo</state>
        <zip>158-0094</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leo Pharma Investigational Site</name>
      <address>
        <city>Setagaya</city>
        <state>Tokyo</state>
        <zip>158-0097</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <results_first_submitted>September 29, 2020</results_first_submitted>
  <results_first_submitted_qc>November 20, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 16, 2020</results_first_posted>
  <last_update_submitted>November 20, 2020</last_update_submitted>
  <last_update_submitted_qc>November 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified Individual Participant Data can be made available to researchers in a closed environment for a specified period of time.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data are available to request after results of the trial are available on leopharmatrials.com</ipd_time_frame>
    <ipd_access_criteria>Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.</ipd_access_criteria>
    <ipd_url>http://leopharmatrials.com/for-professionals</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT03806790/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>June 21, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT03806790/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>LEO 90100 Foam</title>
          <description>calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g&#xD;
LEO 90100 foam: Once daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion.</description>
        </group>
        <group group_id="P2">
          <title>Dovobet® Ointment</title>
          <description>calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g&#xD;
Dovobet® ointment: Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="87"/>
                <participants group_id="P2" count="95"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="87"/>
                <participants group_id="P2" count="95"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>LEO 90100 Foam</title>
          <description>calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g&#xD;
LEO 90100 foam: Once daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion.</description>
        </group>
        <group group_id="B2">
          <title>Dovobet® Ointment</title>
          <description>calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g&#xD;
Dovobet® ointment: Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="87"/>
            <count group_id="B2" value="95"/>
            <count group_id="B3" value="182"/>
          </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="54.2" spread="13.6"/>
                    <measurement group_id="B2" value="54.8" spread="12.9"/>
                    <measurement group_id="B3" value="54.5" spread="13.2"/>
                  </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="29"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="119"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Japanese</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="182"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="182"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Improvement Rate for the Target Lesion</title>
        <description>Overall improvement defined as 'Substantial Resolution' of Clinical Signs or at Least 'Moderately Improved' in the General Change in the Lesion.&#xD;
Substantial resolution' is defined as a clinical score for thickness and scaliness of 0 and a clinical score for redness of 1 or less in the severity of clinical signs of the target lesion. The details of the clinical scores are presented in secondary outcome measure description for 'Change in the total sign score'.&#xD;
Change in the Lesion is a 5 point scale below:&#xD;
Markedly improved (best outcome)&#xD;
Moderately improved&#xD;
Slightly improved&#xD;
Unchanged&#xD;
Aggravated (worst outcome)</description>
        <time_frame>End of Week 4</time_frame>
        <population>The primary endpoint was analysed for the full analysis set. Rates of subjects with the event defined by the primary endpoint, 'overall improvement rate' for the target lesion at Visit 4 (end of Week 4), were compared between treatment groups by means of Fisher's exact test. Estimated rates, odds ratio, and its 95% CI were presented, together with the p-value from Fisher's exact test.</population>
        <group_list>
          <group group_id="O1">
            <title>LEO 90100 Foam</title>
            <description>calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g&#xD;
LEO 90100 foam: Once daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion.</description>
          </group>
          <group group_id="O2">
            <title>Dovobet® Ointment</title>
            <description>calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g&#xD;
Dovobet® ointment: Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Improvement Rate for the Target Lesion</title>
          <description>Overall improvement defined as 'Substantial Resolution' of Clinical Signs or at Least 'Moderately Improved' in the General Change in the Lesion.&#xD;
Substantial resolution' is defined as a clinical score for thickness and scaliness of 0 and a clinical score for redness of 1 or less in the severity of clinical signs of the target lesion. The details of the clinical scores are presented in secondary outcome measure description for 'Change in the total sign score'.&#xD;
Change in the Lesion is a 5 point scale below:&#xD;
Markedly improved (best outcome)&#xD;
Moderately improved&#xD;
Slightly improved&#xD;
Unchanged&#xD;
Aggravated (worst outcome)</description>
          <population>The primary endpoint was analysed for the full analysis set. Rates of subjects with the event defined by the primary endpoint, 'overall improvement rate' for the target lesion at Visit 4 (end of Week 4), were compared between treatment groups by means of Fisher's exact test. Estimated rates, odds ratio, and its 95% CI were presented, together with the p-value from Fisher's exact test.</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="87"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86"/>
                    <measurement group_id="O2" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis on the Full Analysis Set (FAS)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.120</p_value>
            <method>Fisher Exact</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>5.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.68</ci_lower_limit>
            <ci_upper_limit>49.16</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Improvement Rate for the Target Lesion at Weeks 1 and 2</title>
        <description>Substantial resolution of clinical signs or at least 'moderately improved' in the general change in the target lesion.&#xD;
Change in the Lesion is a 5 point scale below:&#xD;
Markedly improved (best outcome)&#xD;
Moderately improved&#xD;
Slightly improved&#xD;
Unchanged&#xD;
Aggravated (worst outcome)</description>
        <time_frame>End of Weeks 1 and 2</time_frame>
        <population>The secondary endpoints were analysed for the full analysis set. The number and percentage of subjects with 'overall improvement' were tabulated for Visits 2 and 3 (end of Weeks 1 and 2) and by treatment group.</population>
        <group_list>
          <group group_id="O1">
            <title>LEO 90100 Foam</title>
            <description>calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g&#xD;
LEO 90100 foam: Once daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion.</description>
          </group>
          <group group_id="O2">
            <title>Dovobet® Ointment</title>
            <description>calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g&#xD;
Dovobet® ointment: Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Improvement Rate for the Target Lesion at Weeks 1 and 2</title>
          <description>Substantial resolution of clinical signs or at least 'moderately improved' in the general change in the target lesion.&#xD;
Change in the Lesion is a 5 point scale below:&#xD;
Markedly improved (best outcome)&#xD;
Moderately improved&#xD;
Slightly improved&#xD;
Unchanged&#xD;
Aggravated (worst outcome)</description>
          <population>The secondary endpoints were analysed for the full analysis set. The number and percentage of subjects with 'overall improvement' were tabulated for Visits 2 and 3 (end of Weeks 1 and 2) and by treatment group.</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="87"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83"/>
                    <measurement group_id="O2" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>End of Week 1 (FAS)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.004</p_value>
            <method>Fisher Exact</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.36</ci_lower_limit>
            <ci_upper_limit>4.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>End of Week 2 (FAS)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.003</p_value>
            <method>Fisher Exact</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>4.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.57</ci_lower_limit>
            <ci_upper_limit>14.97</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Total Sign Score for the Target Lesion From Week 0 to Week 4</title>
        <description>The change in the total sign score from Week 0 to Week 4; total sign score is defined as the sum of the scores from the 3 clinical signs (redness, thickness, and scaliness) assessing severity in the target lesion.&#xD;
The severity for each of the 3 clinical signs was recorded according to a 9-point scale that ranges from a score of 0 to 4 in increments of 0.5; the severities are scored from low to high with 0 = none and 4 = severe. The sum of the 3 total sign scores could range from 0 (best) to 12 (worse). The greater the negative value for the change means a better outcome.&#xD;
Negative change denotes a decrease in the score and therefore a decrease in disease severity.</description>
        <time_frame>End of Week 4</time_frame>
        <population>The secondary endpoints were analysed for the full analysis set. For the change in the total sign score, the estimated difference between the treatment groups in the mean change (LEO 90100 foam group - Dovobet® ointment group) was calculated with 95% confidence interval. The treatment difference of the change in the total sign score at Visit 4 was estimated with an ANOVA with treatment as fixed effect.</population>
        <group_list>
          <group group_id="O1">
            <title>LEO 90100 Foam</title>
            <description>calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g&#xD;
LEO 90100 foam: Once daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion.</description>
          </group>
          <group group_id="O2">
            <title>Dovobet® Ointment</title>
            <description>calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g&#xD;
Dovobet® ointment: Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Total Sign Score for the Target Lesion From Week 0 to Week 4</title>
          <description>The change in the total sign score from Week 0 to Week 4; total sign score is defined as the sum of the scores from the 3 clinical signs (redness, thickness, and scaliness) assessing severity in the target lesion.&#xD;
The severity for each of the 3 clinical signs was recorded according to a 9-point scale that ranges from a score of 0 to 4 in increments of 0.5; the severities are scored from low to high with 0 = none and 4 = severe. The sum of the 3 total sign scores could range from 0 (best) to 12 (worse). The greater the negative value for the change means a better outcome.&#xD;
Negative change denotes a decrease in the score and therefore a decrease in disease severity.</description>
          <population>The secondary endpoints were analysed for the full analysis set. For the change in the total sign score, the estimated difference between the treatment groups in the mean change (LEO 90100 foam group - Dovobet® ointment group) was calculated with 95% confidence interval. The treatment difference of the change in the total sign score at Visit 4 was estimated with an ANOVA with treatment as fixed effect.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.09" spread="1.48"/>
                    <measurement group_id="O2" value="-5.98" spread="2.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>FAS</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Estimated difference</param_type>
            <param_value>-1.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.64</ci_lower_limit>
            <ci_upper_limit>-0.59</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Adverse Events</title>
        <description>Number of treatment emergent adverse events (TEAEs). 14-day follow-up of TEAEs was only required if the TEAE was present at the last visit, and was of possible or probable relationship to trial medication.</description>
        <time_frame>Treatment Emergent Adverse Events were assessed from Day 1 to end of Week 4, if Treatment Emergent Adverse Events were noted, they were followed for an additional 14 days</time_frame>
        <population>The analysis of adverse events was based on the safety analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>LEO 90100 Foam</title>
            <description>calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g&#xD;
LEO 90100 foam: Once daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion.</description>
          </group>
          <group group_id="O2">
            <title>Dovobet® Ointment</title>
            <description>calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g&#xD;
Dovobet® ointment: Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Adverse Events</title>
          <description>Number of treatment emergent adverse events (TEAEs). 14-day follow-up of TEAEs was only required if the TEAE was present at the last visit, and was of possible or probable relationship to trial medication.</description>
          <population>The analysis of adverse events was based on the safety analysis set.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period</time_frame>
      <group_list>
        <group group_id="E1">
          <title>LEO 90100 Foam</title>
          <description>calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g&#xD;
LEO 90100 foam: Once daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion.</description>
        </group>
        <group group_id="E2">
          <title>Dovobet® Ointment</title>
          <description>calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g&#xD;
Dovobet® ointment: Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Keratitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Furuncle</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="87"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Animal bite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood calcium increased</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Glycosylated haemoglobin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Seborrhoeic keratosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </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" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Pain of skin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="95"/>
              </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>LEO Pharma A/S seeks publication of all phase 3 clinical trials in peer-reviewed journals within 18 months after completion or termination of the clinical trial, regardless of whether the findings are positive or negative. If no publication is submitted by LEO Pharma A/S within these 18 months, the investigator has the right to publish the results from the clinical trial generated by him/herself.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical disclosure</name_or_title>
      <organization>LEO Pharma A/S</organization>
      <phone>+4544945888</phone>
      <email>disclosure@leo-pharma.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/NCT03806790
org study id: LP0053-1422
nct id: NCT03806790
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Comparison of the efficacy of LEO 90100 foam with Dovobet® ointment in the treatment of
      psoriasis in Japanese subjects.
A phase 3, national, multi-centre, 4-week, prospective, randomised, controlled,
      parallel-group, open trial of LEO 90100 foam versus Dovobet® ointment (both treatments
      containing calcipotriol hydrate plus betamethasone dipropionate) in Japanese subjects with
      psoriasis vulgaris.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Improvement Rate for the Target Lesion
time frame: End of Week 4
description: Overall improvement defined as 'Substantial Resolution' of Clinical Signs or at Least 'Moderately Improved' in the General Change in the Lesion.
Substantial resolution' is defined as a clinical score for thickness and scaliness of 0 and a clinical score for redness of 1 or less in the severity of clinical signs of the target lesion. The details of the clinical scores are presented in secondary outcome measure description for 'Change in the total sign score'.
Change in the Lesion is a 5 point scale below:
Markedly improved (best outcome)
Moderately improved
Slightly improved
Unchanged
Aggravated (worst outcome)
measure: Overall Improvement Rate for the Target Lesion at Weeks 1 and 2
time frame: End of Weeks 1 and 2
description: Substantial resolution of clinical signs or at least 'moderately improved' in the general change in the target lesion.
Change in the Lesion is a 5 point scale below:
Markedly improved (best outcome)
Moderately improved
Slightly improved
Unchanged
Aggravated (worst outcome)
measure: Change in the Total Sign Score for the Target Lesion From Week 0 to Week 4
time frame: End of Week 4
description: The change in the total sign score from Week 0 to Week 4; total sign score is defined as the sum of the scores from the 3 clinical signs (redness, thickness, and scaliness) assessing severity in the target lesion.
The severity for each of the 3 clinical signs was recorded according to a 9-point scale that ranges from a score of 0 to 4 in increments of 0.5; the severities are scored from low to high with 0 = none and 4 = severe. The sum of the 3 total sign scores could range from 0 (best) to 12 (worse). The greater the negative value for the change means a better outcome.
Negative change denotes a decrease in the score and therefore a decrease in disease severity.
measure: Number of Adverse Events
time frame: Treatment Emergent Adverse Events were assessed from Day 1 to end of Week 4, if Treatment Emergent Adverse Events were noted, they were followed for an additional 14 days
description: Number of treatment emergent adverse events (TEAEs). 14-day follow-up of TEAEs was only required if the TEAE was present at the last visit, and was of possible or probable relationship to trial medication.
arm group label: LEO 90100 foam
arm group type: Experimental
description: calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g
arm group label: Dovobet® ointment
arm group type: Active Comparator
description: calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g
intervention type: Drug
intervention name: LEO 90100 foam
description: Once daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion.
arm group label: LEO 90100 foam
other name: Enstilar® Foam
intervention type: Drug
intervention name: Dovobet® ointment
description: Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion.
arm group label: Dovobet® ointment
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Expert
role: Study Director
affiliation: LEO Pharma
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country: Japan
responsible party type: Sponsor
mesh term: Psoriasis
sharing ipd: Yes
ipd description: De-identified Individual Participant Data can be made available to researchers in a closed environment for a specified period of time.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data are available to request after results of the trial are available on leopharmatrials.com
ipd access criteria: Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.
ipd url: http://leopharmatrials.com/for-professionals
provided document: 
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participant flow: 
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outcome list: 
reported events: 
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point of contact: 