<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/NCT03802344</url>
  </required_header>
  <id_info>
    <org_study_id>MC2-01-C7</org_study_id>
    <nct_id>NCT03802344</nct_id>
  </id_info>
  <brief_title>This Trial is a Randomised, Multicentre, Investigator-blind, Vehicle and Comparator-controlled, Parallel-group Trial With the Purpose of Evaluation Efficacy, Safety and Convenience of the MC2-01 Cream</brief_title>
  <official_title>A Randomised, Multicentre, Investigator-Blind, Parallel-Group Trial to Evaluate the Efficacy and Safety of MC2-01 Cream Compared to Vehicle and Active Comparator in Subjects With Mild-to-Moderate Psoriasis Vulgaris</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MC2 Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MC2 Therapeutics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial is a randomized, investigator-blind, multicentre, vehicle- and&#xD;
      comparator-controlled, parallel-group trial with the purpose of evaluating the efficacy,&#xD;
      safety and convenience of the MC2-01 cream.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The MC2-01 Cream is designed for optimal patient satisfaction - it quickly absorbs into the&#xD;
      skin leaving it nicely moisturized allowing patients to move on in daily routines. In this&#xD;
      trial, the MC2-01 cream will be compared to a marketed product CAL/BDP combination and&#xD;
      vehicle. The purpose of the trial is to compare the clinical efficacy, safety, and&#xD;
      convenience of this cream to the marketed product. The trial will include a 8-week treatment&#xD;
      period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2018</start_date>
  <completion_date type="Actual">October 2, 2019</completion_date>
  <primary_completion_date type="Actual">October 2, 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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage Change in mPASI (Modified Psoriasis Area and Severity Index) Score</measure>
    <time_frame>8 Weeks</time_frame>
    <description>The extent and severity of the participant's psoriasis is assessed using a modified PASI scoring system (minus scalp, face, and flexures) at each 3 areas (arms, trunk and legs) using a scale from 0 - 6, where 0 = no psoriasis involvement and 6 = 90-100% involvement.&#xD;
The severity is assessed at the 3 areas for each of the sign redness, thickness and scaliness using a scale from 0 - 4, where 0 represents none and 4 represents very severe.&#xD;
The mPASI score is calculated from the individual scores by use of the following equation:&#xD;
Arms 0.2 (Redness + Thickness + Scaliness) E = X Trunk 0.3 (Redness + Thickness + Scaliness) E = Y Legs 0.4 (Redness + Thickness + Scaliness) E = Z The sum of X + Y + Z = m-PASI score resulting in a minimum score of 0 and a maximum score (worst possible) of 64.8.&#xD;
The percent change in mPASI score is defined as the Baseline minus the Week 8 divided by Baseline score multiplied by 100 (if a reduction is seen the value will be presented as a negative number)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Psoriasis Treatment Convenience Scale (PTCS)</measure>
    <time_frame>8 Weeks</time_frame>
    <description>PTCS measures the impact and convenience of the treatment. The scale consists of 6 disease-specific questions, which individually will be rated on a 1-10 points scale, where a score of 1 represents the lowest satisfactory response with the treatment and 10 represents the highest satisfactory response. The questions are: Q1. How easy was the treatment to apply to the skin?; Q2. How greasy was the treatment when applying it to the skin?; Q3. How moisturized did your skin feel after apolying the treatment?; Q4. How greasy did your skin feel after applying the treatment?; Q5. How much did treating you skin disrupt your daily routine?; Q6. Overall, how satisfied were you with the medical treatment? The total PTCS score is calculated as the sum of the first 5 questions, ranging from 5 [low satisfaction] to 50 [high satisfaction].</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">498</enrollment>
  <condition>Psoriasis Vulgaris</condition>
  <arm_group>
    <arm_group_label>MC2-01 Cream</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cal/BDP combination</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>One application daily for 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MC2-01 cream</intervention_name>
    <description>MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream</description>
    <arm_group_label>MC2-01 Cream</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cal/BDP combination</intervention_name>
    <description>Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%</description>
    <arm_group_label>Cal/BDP combination</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vehicle</intervention_name>
    <description>Vehicle cream</description>
    <arm_group_label>Vehicle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have provided written informed consent&#xD;
&#xD;
          -  Generally healthy males or non-pregnant females, of any race or ethnicity, who are at&#xD;
             least 18 years of age at the time of screening&#xD;
&#xD;
          -  Have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6&#xD;
             months duration that involves the body (trunk and/or limbs) that is amenable to&#xD;
             topical treatment with a maximum of 15 g of trial medication per day&#xD;
&#xD;
          -  Have a PGA of disease severity of mild or moderate on the body (trunk and/or limbs)&#xD;
&#xD;
          -  Have an mPASI score of at least 3&#xD;
&#xD;
          -  Have a treatment area involving 2-30% of the body (trunk and/or limbs). For subjects&#xD;
             with scalp psoriasis included in the treatment area, the total treatment area on body&#xD;
             and scalp must not exceed 30%.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current diagnosis of unstable forms of psoriasis&#xD;
&#xD;
          -  Other inflammatory skin disease in the treatment area that may confound the evaluation&#xD;
             of the psoriasis vulgaris&#xD;
&#xD;
          -  Presence of pigmentation, extensive scarring, pigmented lesions or sunburn in the&#xD;
             treatment areas&#xD;
&#xD;
          -  Planned excessive or prolonged exposure to either natural or artificial sunlight&#xD;
&#xD;
          -  History of hypersensitivity to any component of the test product or reference product&#xD;
&#xD;
          -  Current or past history of hypercalcemia, vitamin D toxicity, severe renal&#xD;
             insufficiency, or severe hepatic disorders&#xD;
&#xD;
          -  Systemic treatment with biological therapies&#xD;
&#xD;
          -  Use of systemic treatments that suppress the immune system and other systemic&#xD;
             chemotherapeutic antineoplastic therapy within 4 weeks prior to Visit 1/Baseline and&#xD;
             during the trial&#xD;
&#xD;
          -  Use of phototherapy within 4 weeks prior to Visit 1/Baseline and during the trial&#xD;
&#xD;
          -  Use of topical treatments except for emollients and non-medicated shampoos, with a&#xD;
             possible effect on psoriasis within 2 weeks prior to Visit 1/Baseline&#xD;
&#xD;
          -  Presence of infections in the treatment area (bacteria, viruses, parasites or fungi)&#xD;
             or skin manifestations of atrophic skin, atrophic striae, skin vein fragility,&#xD;
             ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers and wound in the treatment&#xD;
             area&#xD;
&#xD;
          -  Known Human Immunodeficiency Virus (HIV) infection&#xD;
&#xD;
          -  Have any chronic or acute medical condition that may pose a risk to the safety of the&#xD;
             subject, or may interfere with the assessment of safety or efficacy in this trial&#xD;
&#xD;
          -  Initiation of, or expected changes to, concomitant medication that may affect&#xD;
             psoriasis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dermatovenerologie a korektivní dermatologie</name>
      <address>
        <city>Praha 1</city>
        <zip>Těšnov 1163/5 110 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center Hamburg</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <results_first_submitted>September 28, 2020</results_first_submitted>
  <results_first_submitted_qc>November 4, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 27, 2020</results_first_posted>
  <last_update_submitted>November 26, 2020</last_update_submitted>
  <last_update_submitted_qc>November 26, 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>
  <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>October 16, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT03802344/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>October 7, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT03802344/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>First Subject First Visit: 12-Dec-2018. Last Subject Last Visit: 02-Oct-2019.</recruitment_details>
      <pre_assignment_details>Prior to randomization, the subject entered a washout period (if required) where anti-psoriatic treatment and other relevant medication/treatments were discontinued as defined by the exclusion criteria. The washout/screening period could last for up to 30 days, depending on which disallowed treatments the subject received.&#xD;
498 subjects signed the Informed consent form, 490 subjects were randomized and randomly assigned into 3 treatment groups (MC2-01 cream, active comparator, MC2-01 vehicle).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>MC2-01 Cream</title>
          <description>MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks&#xD;
MC2-01 cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream</description>
        </group>
        <group group_id="P2">
          <title>Cal/BDP Combination</title>
          <description>Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks&#xD;
Cal/BDP combination: Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%</description>
        </group>
        <group group_id="P3">
          <title>Vehicle</title>
          <description>One application daily for 8 weeks&#xD;
Vehicle: Vehicle</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="213"/>
                <participants group_id="P2" count="209"/>
                <participants group_id="P3" count="68"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="205"/>
                <participants group_id="P2" count="203"/>
                <participants group_id="P3" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>MC2-01 Cream</title>
          <description>MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks&#xD;
MC2-01 cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream</description>
        </group>
        <group group_id="B2">
          <title>Cal/BDP Combination</title>
          <description>Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks&#xD;
Cal/BDP combination: Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%</description>
        </group>
        <group group_id="B3">
          <title>Vehicle</title>
          <description>One application daily for 8 weeks&#xD;
Vehicle: Vehicle</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="213"/>
            <count group_id="B2" value="209"/>
            <count group_id="B3" value="68"/>
            <count group_id="B4" value="490"/>
          </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="48.6" spread="13.7"/>
                    <measurement group_id="B2" value="51.5" spread="14.8"/>
                    <measurement group_id="B3" value="50.8" spread="13.1"/>
                    <measurement group_id="B4" value="50.2" spread="14.02"/>
                  </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="77"/>
                    <measurement group_id="B2" value="96"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="195"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="136"/>
                    <measurement group_id="B2" value="113"/>
                    <measurement group_id="B3" value="46"/>
                    <measurement group_id="B4" value="295"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="213"/>
                    <measurement group_id="B2" value="209"/>
                    <measurement group_id="B3" value="68"/>
                    <measurement group_id="B4" value="490"/>
                  </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/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race</title>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="211"/>
                    <measurement group_id="B2" value="205"/>
                    <measurement group_id="B3" value="65"/>
                    <measurement group_id="B4" value="481"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Gipsy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>North African</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Czechia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                    <measurement group_id="B2" value="90"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="214"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fitzpatrick Skin Type</title>
          <description>Patients were classified in accordance with the following classification: I (pale white skin, blue/hazel eyes, blond/red hair; II (fair skin, blue eyes); III (darker white skin); IV (Light brown skin); V (brown skin); VI (dark brown or black skin)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>I</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="104"/>
                    <measurement group_id="B2" value="103"/>
                    <measurement group_id="B3" value="29"/>
                    <measurement group_id="B4" value="236"/>
                  </measurement_list>
                </category>
                <category>
                  <title>III</title>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="178"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IV</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>V</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>VI</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <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>Percentage Change in mPASI (Modified Psoriasis Area and Severity Index) Score</title>
        <description>The extent and severity of the participant's psoriasis is assessed using a modified PASI scoring system (minus scalp, face, and flexures) at each 3 areas (arms, trunk and legs) using a scale from 0 - 6, where 0 = no psoriasis involvement and 6 = 90-100% involvement.&#xD;
The severity is assessed at the 3 areas for each of the sign redness, thickness and scaliness using a scale from 0 - 4, where 0 represents none and 4 represents very severe.&#xD;
The mPASI score is calculated from the individual scores by use of the following equation:&#xD;
Arms 0.2 (Redness + Thickness + Scaliness) E = X Trunk 0.3 (Redness + Thickness + Scaliness) E = Y Legs 0.4 (Redness + Thickness + Scaliness) E = Z The sum of X + Y + Z = m-PASI score resulting in a minimum score of 0 and a maximum score (worst possible) of 64.8.&#xD;
The percent change in mPASI score is defined as the Baseline minus the Week 8 divided by Baseline score multiplied by 100 (if a reduction is seen the value will be presented as a negative number)</description>
        <time_frame>8 Weeks</time_frame>
        <population>The analysis was based on the FAS population.</population>
        <group_list>
          <group group_id="O1">
            <title>MC2-01 Cream</title>
            <description>MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks&#xD;
MC2-01 cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream</description>
          </group>
          <group group_id="O2">
            <title>Cal/BDP Combination</title>
            <description>Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks&#xD;
Cal/BDP combination: Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%</description>
          </group>
          <group group_id="O3">
            <title>Vehicle</title>
            <description>One application daily for 8 weeks&#xD;
Vehicle: Vehicle</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Change in mPASI (Modified Psoriasis Area and Severity Index) Score</title>
          <description>The extent and severity of the participant's psoriasis is assessed using a modified PASI scoring system (minus scalp, face, and flexures) at each 3 areas (arms, trunk and legs) using a scale from 0 - 6, where 0 = no psoriasis involvement and 6 = 90-100% involvement.&#xD;
The severity is assessed at the 3 areas for each of the sign redness, thickness and scaliness using a scale from 0 - 4, where 0 represents none and 4 represents very severe.&#xD;
The mPASI score is calculated from the individual scores by use of the following equation:&#xD;
Arms 0.2 (Redness + Thickness + Scaliness) E = X Trunk 0.3 (Redness + Thickness + Scaliness) E = Y Legs 0.4 (Redness + Thickness + Scaliness) E = Z The sum of X + Y + Z = m-PASI score resulting in a minimum score of 0 and a maximum score (worst possible) of 64.8.&#xD;
The percent change in mPASI score is defined as the Baseline minus the Week 8 divided by Baseline score multiplied by 100 (if a reduction is seen the value will be presented as a negative number)</description>
          <population>The analysis was based on the FAS population.</population>
          <units>Percentage change from Baseline</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="213"/>
                <count group_id="O2" value="209"/>
                <count group_id="O3" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-67.5" spread="20.8"/>
                    <measurement group_id="O2" value="-63.5" spread="22.2"/>
                    <measurement group_id="O3" value="-11.7" spread="21.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Psoriasis Treatment Convenience Scale (PTCS)</title>
        <description>PTCS measures the impact and convenience of the treatment. The scale consists of 6 disease-specific questions, which individually will be rated on a 1-10 points scale, where a score of 1 represents the lowest satisfactory response with the treatment and 10 represents the highest satisfactory response. The questions are: Q1. How easy was the treatment to apply to the skin?; Q2. How greasy was the treatment when applying it to the skin?; Q3. How moisturized did your skin feel after apolying the treatment?; Q4. How greasy did your skin feel after applying the treatment?; Q5. How much did treating you skin disrupt your daily routine?; Q6. Overall, how satisfied were you with the medical treatment? The total PTCS score is calculated as the sum of the first 5 questions, ranging from 5 [low satisfaction] to 50 [high satisfaction].</description>
        <time_frame>8 Weeks</time_frame>
        <population>The analysis was based on the FAS population.</population>
        <group_list>
          <group group_id="O1">
            <title>MC2-01 Cream</title>
            <description>MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks&#xD;
MC2-01 cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream</description>
          </group>
          <group group_id="O2">
            <title>Cal/BDP Combination</title>
            <description>Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks&#xD;
Cal/BDP combination: Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%</description>
          </group>
          <group group_id="O3">
            <title>Vehicle</title>
            <description>One application daily for 8 weeks&#xD;
Vehicle: Vehicle cream</description>
          </group>
        </group_list>
        <measure>
          <title>The Psoriasis Treatment Convenience Scale (PTCS)</title>
          <description>PTCS measures the impact and convenience of the treatment. The scale consists of 6 disease-specific questions, which individually will be rated on a 1-10 points scale, where a score of 1 represents the lowest satisfactory response with the treatment and 10 represents the highest satisfactory response. The questions are: Q1. How easy was the treatment to apply to the skin?; Q2. How greasy was the treatment when applying it to the skin?; Q3. How moisturized did your skin feel after apolying the treatment?; Q4. How greasy did your skin feel after applying the treatment?; Q5. How much did treating you skin disrupt your daily routine?; Q6. Overall, how satisfied were you with the medical treatment? The total PTCS score is calculated as the sum of the first 5 questions, ranging from 5 [low satisfaction] to 50 [high satisfaction].</description>
          <population>The analysis was based on the FAS population.</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="213"/>
                <count group_id="O2" value="209"/>
                <count group_id="O3" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.6" spread="6.2"/>
                    <measurement group_id="O2" value="36.1" spread="7.0"/>
                    <measurement group_id="O3" value="36.2" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs were collected/assessed from the time of the signature of the informed consent form by the subject and until the end of the trial, i.e. until the Follow-up visit at Week 10. AEs that were considered related to the trial product would be followed until they were resolved, or until the medical condition of the subject was stable.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>MC2-01 Cream</title>
          <description>MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks&#xD;
MC2-01 cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream</description>
        </group>
        <group group_id="E2">
          <title>Cal/BDP Combination</title>
          <description>Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks&#xD;
Cal/BDP combination: Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%</description>
        </group>
        <group group_id="E3">
          <title>Vehicle</title>
          <description>One application daily for 8 weeks&#xD;
Vehicle: Vehicle</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-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="213"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="209"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="209"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cholesystitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="209"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Herpes zoster meningitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="209"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Pulmonary tuberculosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="209"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="209"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Testicular seminoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="209"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="10" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="209"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="213"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="209"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT 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>Irene Sandholdt</name_or_title>
      <organization>MC2 Therapeutics</organization>
      <phone>+45 2015 7033</phone>
      <email>isa@mc2therapeutics.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/NCT03802344
org study id: MC2-01-C7
nct id: NCT03802344
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This trial is a randomized, investigator-blind, multicentre, vehicle- and
      comparator-controlled, parallel-group trial with the purpose of evaluating the efficacy,
      safety and convenience of the MC2-01 cream.
The MC2-01 Cream is designed for optimal patient satisfaction - it quickly absorbs into the
      skin leaving it nicely moisturized allowing patients to move on in daily routines. In this
      trial, the MC2-01 cream will be compared to a marketed product CAL/BDP combination and
      vehicle. The purpose of the trial is to compare the clinical efficacy, safety, and
      convenience of this cream to the marketed product. The trial will include a 8-week treatment
      period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Percentage Change in mPASI (Modified Psoriasis Area and Severity Index) Score
time frame: 8 Weeks
description: The extent and severity of the participant's psoriasis is assessed using a modified PASI scoring system (minus scalp, face, and flexures) at each 3 areas (arms, trunk and legs) using a scale from 0 - 6, where 0 = no psoriasis involvement and 6 = 90-100% involvement.
The severity is assessed at the 3 areas for each of the sign redness, thickness and scaliness using a scale from 0 - 4, where 0 represents none and 4 represents very severe.
The mPASI score is calculated from the individual scores by use of the following equation:
Arms 0.2 (Redness + Thickness + Scaliness) E = X Trunk 0.3 (Redness + Thickness + Scaliness) E = Y Legs 0.4 (Redness + Thickness + Scaliness) E = Z The sum of X + Y + Z = m-PASI score resulting in a minimum score of 0 and a maximum score (worst possible) of 64.8.
The percent change in mPASI score is defined as the Baseline minus the Week 8 divided by Baseline score multiplied by 100 (if a reduction is seen the value will be presented as a negative number)
measure: The Psoriasis Treatment Convenience Scale (PTCS)
time frame: 8 Weeks
description: PTCS measures the impact and convenience of the treatment. The scale consists of 6 disease-specific questions, which individually will be rated on a 1-10 points scale, where a score of 1 represents the lowest satisfactory response with the treatment and 10 represents the highest satisfactory response. The questions are: Q1. How easy was the treatment to apply to the skin?; Q2. How greasy was the treatment when applying it to the skin?; Q3. How moisturized did your skin feel after apolying the treatment?; Q4. How greasy did your skin feel after applying the treatment?; Q5. How much did treating you skin disrupt your daily routine?; Q6. Overall, how satisfied were you with the medical treatment? The total PTCS score is calculated as the sum of the first 5 questions, ranging from 5 [low satisfaction] to 50 [high satisfaction].
arm group label: MC2-01 Cream
arm group type: Experimental
description: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks
arm group label: Cal/BDP combination
arm group type: Active Comparator
description: Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks
arm group label: Vehicle
arm group type: Placebo Comparator
description: One application daily for 8 weeks
intervention type: Drug
intervention name: MC2-01 cream
description: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream
arm group label: MC2-01 Cream
intervention type: Drug
intervention name: Cal/BDP combination
description: Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%
arm group label: Cal/BDP combination
intervention type: Drug
intervention name: Vehicle
description: Vehicle cream
arm group label: Vehicle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Czechia
country: Germany
responsible party type: Sponsor
mesh term: Psoriasis
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 