<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/NCT03819218</url>
  </required_header>
  <id_info>
    <org_study_id>MC2-01-C6</org_study_id>
    <nct_id>NCT03819218</nct_id>
  </id_info>
  <brief_title>A Maximal Use Trial Evaluating the Pharmacokinetic Profile of MC2-01 Cream in Adolescent Subjects</brief_title>
  <official_title>A Multicentre, Open-label, Single-group Maximal Use Trial, Evaluating the Safety and Pharmacokinetic Profile of the Active Ingredients and Their Metabolites After Application of MC2-01 Cream in Adolescents With Extensive 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 is a phase 2, open-label, single-group, multicentre trial in which the investigational&#xD;
      product, MC2-01 cream, is investigated in adolescent subjects (age 12 to 16 years, 11 months)&#xD;
      with clinically diagnosed extensive psoriasis vulgaris.&#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 with daily routines. In this&#xD;
      trial, subjects who fulfil all inclusion and exclusion criteria are enrolled in the trial and&#xD;
      will apply one dose of trial medication topically once daily for 8 weeks. The purpose of the&#xD;
      trial, is to determine the and pharmacokinetic parameters of MC2-01 cream in adolescent&#xD;
      subjects under maximum use conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">December 27, 2018</start_date>
  <completion_date type="Actual">December 11, 2020</completion_date>
  <primary_completion_date type="Actual">December 11, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With HPA (Hypothalamic-pituitary-adrenal) Axis Suppression at Week 4</measure>
    <time_frame>Week 4</time_frame>
    <description>Adrenal function will be assessed in a challenge test with an intravenous dose of cosyntropin. Measurement of serum cortisol levels pre- and post- stimulation is an accepted standard method used to evaluate adrenal suppression.&#xD;
The test consists of an initial blood sampling. Following the blood sample, an intravenous bolus injection of 0.25 mg cosyntropin is given. The serum cortisol concentration 30 min. after will reflect stimulation of the adrenal glands induced by cosyntropin. HPA axis suppression is define as serum cortisol below 18 µg/dL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With HPA (Hypothalamic-pituitary-adrenal) Axis Suppression at Week 8</measure>
    <time_frame>Week 8</time_frame>
    <description>Adrenal function will be assessed in a challenge test with an intravenous dose of cosyntropin. Measurement of serum cortisol levels pre- and post- stimulation is an accepted standard method used to evaluate adrenal suppression.&#xD;
The test consists of an initial blood sampling. Following the blood sample, an intravenous bolus injection of 0.25 mg cosyntropin is given. The serum cortisol concentration 30 min. after will reflect stimulation of the adrenal glands induced by cosyntropin. HPA axis suppression is define as serum cortisol below 18 µg/dL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in S-Calcium Metabolism at Week 4</measure>
    <time_frame>Week 4</time_frame>
    <description>Change from Baseline to Week 4 in albumin-corrected S-calcium</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in S-Calcium Metabolism at Week 8</measure>
    <time_frame>Week 8</time_frame>
    <description>Change from Baseline to Week 8 in albumin-corrected S-calcium</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in U-Calcium Metabolism at Week 4</measure>
    <time_frame>Week 4</time_frame>
    <description>Change from Baseline to Week 4 in Urinary Calcium/Creatinine ratio (mol/mol)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in U-Calcium Metabolism at Week 8</measure>
    <time_frame>Week 8</time_frame>
    <description>Change from Baseline to Week 8 in Urinary Calcium/Creatinine ratio (mol/mol)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Maximum Plasma Concentration [Cmax] of Betamethasone 17-propionate at Week 4</measure>
    <time_frame>Week 4</time_frame>
    <description>The Maximum Plasma Concentration [Cmax] of the metabolite of BDP, betamethasone 17-propionate measured at Week 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Maximum Plasma Drug Concentration [Tmax] of Betamethasone 17-propionate at Week 4</measure>
    <time_frame>Week 4</time_frame>
    <description>Time to maximum plasma drug concentration [Tmax] of the metabolite of BDP, betamethasone 17-propionate measured at Week 4.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</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>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MC2-01 cream</intervention_name>
    <description>MC2-01 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)</description>
    <arm_group_label>MC2-01 cream</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The parent(s), or legal guardian(s) (according to national law) have provided written&#xD;
             informed consent following their receipt of verbal and written information about the&#xD;
             trial&#xD;
&#xD;
          -  The subject (according to national law) has provided written assent to the trial&#xD;
             following their receipt of verbal and written information about the trial&#xD;
&#xD;
          -  Generally healthy males or non-pregnant females, of any race or ethnicity, who are&#xD;
             between 12 to 16 years, 11-month-old at Screening Visit 1 (SV1)&#xD;
&#xD;
          -  At Visit 1/Day 0, have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris)&#xD;
             of at least 6 months duration involving body (trunk and/or limbs), with or without&#xD;
             scalp&#xD;
&#xD;
          -  Have a treatment area between 10% and 30% of the Body Surface Area (BSA) on the body&#xD;
             (trunk and/or limbs) and scalp, excluding psoriatic lesions on the face, genitals, and&#xD;
             intertriginous areas, at Visit 1/Day 0&#xD;
&#xD;
          -  Have a Physician's Global Assessment (PGA) of at least moderate severity on the&#xD;
             treatment area&#xD;
&#xD;
          -  A normal HPA axis function including a serum cortisol concentration above 4,5 mcg/dl&#xD;
             before ACTH-challenge and equal or above 18 mcg/dl 30 minutes after ACTH challenge, at&#xD;
             Screening Visit 2 (SV2)&#xD;
&#xD;
          -  A serum albumin-corrected calcium below the upper reference limit at SV2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have a current diagnosis of unstable forms of psoriasis, including erythrodermic or&#xD;
             pustular 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 infections in the treatment area or skin manifestations or atrophic skin,&#xD;
             atrophic striae, skin vein fragility, ichthyosis, acne vulgaris, acne rosacea,&#xD;
             rosacea, ulcers and wounds in the treatment area&#xD;
&#xD;
          -  Presence of pigmentation, extensive scarring, pigmented lesions or sunburn in the&#xD;
             treatment areas, which could interfere with the rating of efficacy parameters&#xD;
&#xD;
          -  Planned excessive or prolonged exposure to either natural or artificial sunlight&#xD;
&#xD;
          -  Use of phototherapy (psoralen + ultraviolet A radiation and ultraviolet B radiation&#xD;
             within 4 weeks prior to SV2 and during the trial&#xD;
&#xD;
          -  Current or past history of disorders of calcium metabolism associated with&#xD;
             hypercalcemia, vitamin D toxicity, severe renal insufficiency, or severe hepatic&#xD;
             disorders&#xD;
&#xD;
          -  Oral calcium supplements, vitamin D supplements, bisphosphonates or calcitonin within&#xD;
             4 weeks prior to SV2&#xD;
&#xD;
          -  Planned initiation of, or changes to concomitant medication that could affect calcium&#xD;
             metabolism during the trial;&#xD;
&#xD;
          -  Planned initiation of, or changes to, concomitant estrogen therapy during the trial&#xD;
&#xD;
          -  Strong systemic cytochrome P450 3A4 (CYP 3A4) inhibitors or inducers within 4 weeks&#xD;
             prior to SV2 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 SV2 and during the trial&#xD;
&#xD;
          -  Systemic treatment with biological therapies, with a possible effect on psoriasis&#xD;
             vulgaris within the following time period prior to SV2 and during the trial&#xD;
&#xD;
          -  Initiation of, or expected changes to, concomitant medication that may affect&#xD;
             psoriasis during the trial&#xD;
&#xD;
          -  Any of the following conditions, whether known or suspected; Clinically diagnosed&#xD;
             depression where the subject is in current treatment with medication approved for&#xD;
             treatment of depression; Endocrine disorders known to affect cortisol levels or HPA&#xD;
             axis integrity; Non-nocturnal sleep patterns&#xD;
&#xD;
          -  Use of systemic medication that suppresses the immune system and other systemic&#xD;
             chemotherapeutic antineoplastic therapy within 4 weeks prior to the SV2 and during the&#xD;
             trial&#xD;
&#xD;
          -  Use of live vaccines 4 weeks before SV2 and during the trial&#xD;
&#xD;
          -  Have clinical signs of skin infection with bacteria, viruses, or fungi&#xD;
&#xD;
          -  Known human immunodeficiency virus (HIV) infection, active hepatitis B or hepatitis C&#xD;
&#xD;
          -  Known or suspected of hypersensitivity to any component of the test product&#xD;
&#xD;
          -  Known allergic asthma, serious allergies or allergies where recurrent acute or chronic&#xD;
             treatment is necessary&#xD;
&#xD;
          -  Have any chronic or acute medical condition that, in the opinion of the investigator,&#xD;
             may pose a risk to the safety of the subject, or may interfere with the assessment of&#xD;
             safety or efficacy in this trial&#xD;
&#xD;
          -  Require the use of any concomitant medication that, in the investigator's opinion, has&#xD;
             the potential to cause an adverse effect when given with the Investigational Product&#xD;
             (IP) or will interfere with the interpretation of the trial results&#xD;
&#xD;
          -  Subject with known abnormal reduction in muscle mass, as judged by the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andreas Pinter, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept. of Dermatology, Venereology and Allergology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PRO SANUM a.s.</name>
      <address>
        <city>Prague</city>
        <zip>110 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dept. of Dermatology, Venereology and Allergology</name>
      <address>
        <city>Frankfurt</city>
        <state>Frankfurt/Main</state>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <results_first_submitted>February 1, 2021</results_first_submitted>
  <results_first_submitted_qc>February 1, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 21, 2021</results_first_posted>
  <last_update_submitted>February 23, 2021</last_update_submitted>
  <last_update_submitted_qc>February 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2021</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>September 23, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT03819218/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>September 7, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT03819218/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <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 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_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 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="7"/>
          </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="14.7" spread="1.4"/>
                  </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="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </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_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With HPA (Hypothalamic-pituitary-adrenal) Axis Suppression at Week 4</title>
        <description>Adrenal function will be assessed in a challenge test with an intravenous dose of cosyntropin. Measurement of serum cortisol levels pre- and post- stimulation is an accepted standard method used to evaluate adrenal suppression.&#xD;
The test consists of an initial blood sampling. Following the blood sample, an intravenous bolus injection of 0.25 mg cosyntropin is given. The serum cortisol concentration 30 min. after will reflect stimulation of the adrenal glands induced by cosyntropin. HPA axis suppression is define as serum cortisol below 18 µg/dL</description>
        <time_frame>Week 4</time_frame>
        <population>The HPA population was defined as all subjects in the safety population that showed a normal HPA function at the screening visit.</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 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With HPA (Hypothalamic-pituitary-adrenal) Axis Suppression at Week 4</title>
          <description>Adrenal function will be assessed in a challenge test with an intravenous dose of cosyntropin. Measurement of serum cortisol levels pre- and post- stimulation is an accepted standard method used to evaluate adrenal suppression.&#xD;
The test consists of an initial blood sampling. Following the blood sample, an intravenous bolus injection of 0.25 mg cosyntropin is given. The serum cortisol concentration 30 min. after will reflect stimulation of the adrenal glands induced by cosyntropin. HPA axis suppression is define as serum cortisol below 18 µg/dL</description>
          <population>The HPA population was defined as all subjects in the safety population that showed a normal HPA function at the screening visit.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With HPA (Hypothalamic-pituitary-adrenal) Axis Suppression at Week 8</title>
        <description>Adrenal function will be assessed in a challenge test with an intravenous dose of cosyntropin. Measurement of serum cortisol levels pre- and post- stimulation is an accepted standard method used to evaluate adrenal suppression.&#xD;
The test consists of an initial blood sampling. Following the blood sample, an intravenous bolus injection of 0.25 mg cosyntropin is given. The serum cortisol concentration 30 min. after will reflect stimulation of the adrenal glands induced by cosyntropin. HPA axis suppression is define as serum cortisol below 18 µg/dL</description>
        <time_frame>Week 8</time_frame>
        <population>The HPA population was defined as all subjects in the safety population that showed a normal HPA function at the screening visit.</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 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With HPA (Hypothalamic-pituitary-adrenal) Axis Suppression at Week 8</title>
          <description>Adrenal function will be assessed in a challenge test with an intravenous dose of cosyntropin. Measurement of serum cortisol levels pre- and post- stimulation is an accepted standard method used to evaluate adrenal suppression.&#xD;
The test consists of an initial blood sampling. Following the blood sample, an intravenous bolus injection of 0.25 mg cosyntropin is given. The serum cortisol concentration 30 min. after will reflect stimulation of the adrenal glands induced by cosyntropin. HPA axis suppression is define as serum cortisol below 18 µg/dL</description>
          <population>The HPA population was defined as all subjects in the safety population that showed a normal HPA function at the screening visit.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in S-Calcium Metabolism at Week 4</title>
        <description>Change from Baseline to Week 4 in albumin-corrected S-calcium</description>
        <time_frame>Week 4</time_frame>
        <population>7 subjects were included in the safety population at baseline and Week 4. At Week 8 1 subjects was withdrawn.</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 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)</description>
          </group>
        </group_list>
        <measure>
          <title>Change in S-Calcium Metabolism at Week 4</title>
          <description>Change from Baseline to Week 4 in albumin-corrected S-calcium</description>
          <population>7 subjects were included in the safety population at baseline and Week 4. At Week 8 1 subjects was withdrawn.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.037" spread="0.084"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in S-Calcium Metabolism at Week 8</title>
        <description>Change from Baseline to Week 8 in albumin-corrected S-calcium</description>
        <time_frame>Week 8</time_frame>
        <population>7 subjects were included in the safety population at baseline and Week 4. At Week 8 1 subjects was withdrawn.</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 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)</description>
          </group>
        </group_list>
        <measure>
          <title>Change in S-Calcium Metabolism at Week 8</title>
          <description>Change from Baseline to Week 8 in albumin-corrected S-calcium</description>
          <population>7 subjects were included in the safety population at baseline and Week 4. At Week 8 1 subjects was withdrawn.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.027" spread="0.060"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in U-Calcium Metabolism at Week 4</title>
        <description>Change from Baseline to Week 4 in Urinary Calcium/Creatinine ratio (mol/mol)</description>
        <time_frame>Week 4</time_frame>
        <population>7 subjects were included in the safety population at baseline and Week 4. At Week 8 1 subjects was withdrawn.</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 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)</description>
          </group>
        </group_list>
        <measure>
          <title>Change in U-Calcium Metabolism at Week 4</title>
          <description>Change from Baseline to Week 4 in Urinary Calcium/Creatinine ratio (mol/mol)</description>
          <population>7 subjects were included in the safety population at baseline and Week 4. At Week 8 1 subjects was withdrawn.</population>
          <units>mol/mol</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.115" spread="0.426"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in U-Calcium Metabolism at Week 8</title>
        <description>Change from Baseline to Week 8 in Urinary Calcium/Creatinine ratio (mol/mol)</description>
        <time_frame>Week 8</time_frame>
        <population>7 subjects were included in the safety population at baseline and Week 4. At Week 8 1 subjects was withdrawn.</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 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)</description>
          </group>
        </group_list>
        <measure>
          <title>Change in U-Calcium Metabolism at Week 8</title>
          <description>Change from Baseline to Week 8 in Urinary Calcium/Creatinine ratio (mol/mol)</description>
          <population>7 subjects were included in the safety population at baseline and Week 4. At Week 8 1 subjects was withdrawn.</population>
          <units>mol/mol</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.058" spread="0,186"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Maximum Plasma Concentration [Cmax] of Betamethasone 17-propionate at Week 4</title>
        <description>The Maximum Plasma Concentration [Cmax] of the metabolite of BDP, betamethasone 17-propionate measured at Week 4.</description>
        <time_frame>Week 4</time_frame>
        <population>The Maximum Plasma Concentration [Cmax] of the metabolite of BDP, betamethasone 17-propionate, was quantifiable in 3 out of 6 (50 %) participants only, thus the data only reflects result from 3 participants. The 3 remaining participants had values below Lower Limit of Quantification (LLOQ).</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 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)</description>
          </group>
        </group_list>
        <measure>
          <title>The Maximum Plasma Concentration [Cmax] of Betamethasone 17-propionate at Week 4</title>
          <description>The Maximum Plasma Concentration [Cmax] of the metabolite of BDP, betamethasone 17-propionate measured at Week 4.</description>
          <population>The Maximum Plasma Concentration [Cmax] of the metabolite of BDP, betamethasone 17-propionate, was quantifiable in 3 out of 6 (50 %) participants only, thus the data only reflects result from 3 participants. The 3 remaining participants had values below Lower Limit of Quantification (LLOQ).</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.53" spread="22.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Maximum Plasma Drug Concentration [Tmax] of Betamethasone 17-propionate at Week 4</title>
        <description>Time to maximum plasma drug concentration [Tmax] of the metabolite of BDP, betamethasone 17-propionate measured at Week 4.</description>
        <time_frame>Week 4</time_frame>
        <population>The Maximum Plasma Concentration [Cmax] of the metabolite of BDP, betamethasone 17-propionate, was quantifiable in 3 out of 6 (50 %) participants only, thus the data only reflects result from 3 participants. The 3 remaining participants had values below Lower Limit of Quantification (LLOQ).</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 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Maximum Plasma Drug Concentration [Tmax] of Betamethasone 17-propionate at Week 4</title>
          <description>Time to maximum plasma drug concentration [Tmax] of the metabolite of BDP, betamethasone 17-propionate measured at Week 4.</description>
          <population>The Maximum Plasma Concentration [Cmax] of the metabolite of BDP, betamethasone 17-propionate, was quantifiable in 3 out of 6 (50 %) participants only, thus the data only reflects result from 3 participants. The 3 remaining participants had values below Lower Limit of Quantification (LLOQ).</population>
          <units>Hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.333" spread="1.155"/>
                  </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 participant and until the final follow-up visit has occurred, i.e. up to in total up to 18 weeks, including a screening period of up to 6 weeks, a treatment period of 8 weeks and a follow-up period of 4 weeks. AEs that were considered related to the trial product would be followed until they were resolved, or until the medical condition of the participant 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 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)</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="7"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
              </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="3" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</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/NCT03819218
org study id: MC2-01-C6
nct id: NCT03819218
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a phase 2, open-label, single-group, multicentre trial in which the investigational
      product, MC2-01 cream, is investigated in adolescent subjects (age 12 to 16 years, 11 months)
      with clinically diagnosed extensive psoriasis vulgaris.
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 with daily routines. In this
      trial, subjects who fulfil all inclusion and exclusion criteria are enrolled in the trial and
      will apply one dose of trial medication topically once daily for 8 weeks. The purpose of the
      trial, is to determine the and pharmacokinetic parameters of MC2-01 cream in adolescent
      subjects under maximum use conditions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With HPA (Hypothalamic-pituitary-adrenal) Axis Suppression at Week 4
time frame: Week 4
description: Adrenal function will be assessed in a challenge test with an intravenous dose of cosyntropin. Measurement of serum cortisol levels pre- and post- stimulation is an accepted standard method used to evaluate adrenal suppression.
The test consists of an initial blood sampling. Following the blood sample, an intravenous bolus injection of 0.25 mg cosyntropin is given. The serum cortisol concentration 30 min. after will reflect stimulation of the adrenal glands induced by cosyntropin. HPA axis suppression is define as serum cortisol below 18 µg/dL
measure: Number of Participants With HPA (Hypothalamic-pituitary-adrenal) Axis Suppression at Week 8
time frame: Week 8
description: Adrenal function will be assessed in a challenge test with an intravenous dose of cosyntropin. Measurement of serum cortisol levels pre- and post- stimulation is an accepted standard method used to evaluate adrenal suppression.
The test consists of an initial blood sampling. Following the blood sample, an intravenous bolus injection of 0.25 mg cosyntropin is given. The serum cortisol concentration 30 min. after will reflect stimulation of the adrenal glands induced by cosyntropin. HPA axis suppression is define as serum cortisol below 18 µg/dL
measure: Change in S-Calcium Metabolism at Week 4
time frame: Week 4
description: Change from Baseline to Week 4 in albumin-corrected S-calcium
measure: Change in S-Calcium Metabolism at Week 8
time frame: Week 8
description: Change from Baseline to Week 8 in albumin-corrected S-calcium
measure: Change in U-Calcium Metabolism at Week 4
time frame: Week 4
description: Change from Baseline to Week 4 in Urinary Calcium/Creatinine ratio (mol/mol)
measure: Change in U-Calcium Metabolism at Week 8
time frame: Week 8
description: Change from Baseline to Week 8 in Urinary Calcium/Creatinine ratio (mol/mol)
measure: The Maximum Plasma Concentration [Cmax] of Betamethasone 17-propionate at Week 4
time frame: Week 4
description: The Maximum Plasma Concentration [Cmax] of the metabolite of BDP, betamethasone 17-propionate measured at Week 4.
measure: Time to Maximum Plasma Drug Concentration [Tmax] of Betamethasone 17-propionate at Week 4
time frame: Week 4
description: Time to maximum plasma drug concentration [Tmax] of the metabolite of BDP, betamethasone 17-propionate measured at Week 4.
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
intervention type: Drug
intervention name: MC2-01 cream
description: MC2-01 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)
arm group label: MC2-01 cream
criteria: 
gender: All
minimum age: 12 Years
maximum age: 16 Years
healthy volunteers: No
last name: Andreas Pinter, MD
role: Principal Investigator
affiliation: Dept. of Dermatology, Venereology and Allergology
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: 