<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/NCT02973776</url>
  </required_header>
  <id_info>
    <org_study_id>LP0053-1276</org_study_id>
    <nct_id>NCT02973776</nct_id>
  </id_info>
  <brief_title>Vasoconstriction Trial With LEO 90100 Aerosol Foam</brief_title>
  <official_title>Vasoconstriction Trial Comparing LEO 90100 With Dermovate Cream, Diprosone Ointment, Elocon Cream, Locoid Ointment and LEO 90100 Vehicle</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LEO Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LEO Pharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Vasoconstriction study with LEO 90100&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study compares the pharmacodynamic activity of LEO 90100 with Dermovate cream, Diprosone&#xD;
      ointment, Elocon cream, Locoid ointment and LEO 90100 vehicle using a human skin blanching&#xD;
      test&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean of two visual skin blanching scores for each treatment measured 2 hours after 16 hours application under non-occlusive conditions</measure>
    <time_frame>18 hours</time_frame>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Psoriasis Vulgaris</condition>
  <arm_group>
    <arm_group_label>LEO 90100 aerosol foam</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LEO 90100 calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) aerosol foam&#xD;
Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dermoval®/Dermovate®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dermoval®/Dermovate® (clobetasol propionate 0.05%) cream&#xD;
Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diprosone®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Diprosone® betamethasone 0.5 mg/g (as dipropionate) ointment&#xD;
Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Elocon®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Elocon® mometasone furoate 0.1% cream&#xD;
Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Locoid®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Locoid® hydrocortisone-17-butyrate 0.1% ointment&#xD;
Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LEO 90100 foam vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>LEO 90100 foam vehicle&#xD;
Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LEO 90100 aerosol foam</intervention_name>
    <arm_group_label>Dermoval®/Dermovate®</arm_group_label>
    <arm_group_label>Diprosone®</arm_group_label>
    <arm_group_label>Elocon®</arm_group_label>
    <arm_group_label>LEO 90100 aerosol foam</arm_group_label>
    <arm_group_label>LEO 90100 foam vehicle</arm_group_label>
    <arm_group_label>Locoid®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dermoval®/Dermovate®</intervention_name>
    <arm_group_label>Dermoval®/Dermovate®</arm_group_label>
    <arm_group_label>Diprosone®</arm_group_label>
    <arm_group_label>Elocon®</arm_group_label>
    <arm_group_label>LEO 90100 aerosol foam</arm_group_label>
    <arm_group_label>LEO 90100 foam vehicle</arm_group_label>
    <arm_group_label>Locoid®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diprosone</intervention_name>
    <arm_group_label>Dermoval®/Dermovate®</arm_group_label>
    <arm_group_label>Diprosone®</arm_group_label>
    <arm_group_label>Elocon®</arm_group_label>
    <arm_group_label>LEO 90100 aerosol foam</arm_group_label>
    <arm_group_label>LEO 90100 foam vehicle</arm_group_label>
    <arm_group_label>Locoid®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Elocon</intervention_name>
    <arm_group_label>Dermoval®/Dermovate®</arm_group_label>
    <arm_group_label>Diprosone®</arm_group_label>
    <arm_group_label>Elocon®</arm_group_label>
    <arm_group_label>LEO 90100 aerosol foam</arm_group_label>
    <arm_group_label>LEO 90100 foam vehicle</arm_group_label>
    <arm_group_label>Locoid®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Locoid</intervention_name>
    <arm_group_label>Dermoval®/Dermovate®</arm_group_label>
    <arm_group_label>Diprosone®</arm_group_label>
    <arm_group_label>Elocon®</arm_group_label>
    <arm_group_label>LEO 90100 aerosol foam</arm_group_label>
    <arm_group_label>LEO 90100 foam vehicle</arm_group_label>
    <arm_group_label>Locoid®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>LEO 90100 foam vehicle</intervention_name>
    <arm_group_label>Dermoval®/Dermovate®</arm_group_label>
    <arm_group_label>Diprosone®</arm_group_label>
    <arm_group_label>Elocon®</arm_group_label>
    <arm_group_label>LEO 90100 aerosol foam</arm_group_label>
    <arm_group_label>LEO 90100 foam vehicle</arm_group_label>
    <arm_group_label>Locoid®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects demonstrating adequate vasoconstriction to Diprosone® ointment within 15 days&#xD;
             prior to dosing (unoccluded application of Diprosone® ointment for 4-6 hours must show&#xD;
             a visual score of skin blanching of at least one unit (visual scale (0-4)).&#xD;
&#xD;
          -  Subjects without signs of skin irritation/disease/disorders/symptoms or blemishes on&#xD;
             test sites (e.g. erythema, dryness, roughness, scaling, scars, moles, sunburn).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Abnormal pigmentation of the skin or skin type that could, in any way, confound&#xD;
             interpretation of the trial results (skin type V and VI on the Fitzpatrick scale).&#xD;
&#xD;
          -  Female subjects who are breastfeeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CPCAD</name>
      <address>
        <city>Nice</city>
        <state>Cedex</state>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>May 8, 2017</last_update_submitted>
  <last_update_submitted_qc>May 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2017</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clobetasol</mesh_term>
    <mesh_term>Betamethasone-17,21-dipropionate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02973776
org study id: LP0053-1276
nct id: NCT02973776
lead sponsor: 
has dmc: No
Vasoconstriction study with LEO 90100
This study compares the pharmacodynamic activity of LEO 90100 with Dermovate cream, Diprosone
      ointment, Elocon cream, Locoid ointment and LEO 90100 vehicle using a human skin blanching
      test
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Mean of two visual skin blanching scores for each treatment measured 2 hours after 16 hours application under non-occlusive conditions
time frame: 18 hours
arm group label: LEO 90100 aerosol foam
arm group type: Experimental
description: LEO 90100 calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) aerosol foam
Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once.
arm group label: Dermoval®/Dermovate®
arm group type: Active Comparator
description: Dermoval®/Dermovate® (clobetasol propionate 0.05%) cream
Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once.
arm group label: Diprosone®
arm group type: Active Comparator
description: Diprosone® betamethasone 0.5 mg/g (as dipropionate) ointment
Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once.
arm group label: Elocon®
arm group type: Active Comparator
description: Elocon® mometasone furoate 0.1% cream
Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once.
arm group label: Locoid®
arm group type: Active Comparator
description: Locoid® hydrocortisone-17-butyrate 0.1% ointment
Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once.
arm group label: LEO 90100 foam vehicle
arm group type: Placebo Comparator
description: LEO 90100 foam vehicle
Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once.
intervention type: Drug
intervention name: LEO 90100 aerosol foam
arm group label: Dermoval®/Dermovate®
arm group label: Diprosone®
arm group label: Elocon®
arm group label: LEO 90100 aerosol foam
arm group label: LEO 90100 foam vehicle
arm group label: Locoid®
intervention type: Drug
intervention name: Dermoval®/Dermovate®
arm group label: Dermoval®/Dermovate®
arm group label: Diprosone®
arm group label: Elocon®
arm group label: LEO 90100 aerosol foam
arm group label: LEO 90100 foam vehicle
arm group label: Locoid®
intervention type: Drug
intervention name: Diprosone
arm group label: Dermoval®/Dermovate®
arm group label: Diprosone®
arm group label: Elocon®
arm group label: LEO 90100 aerosol foam
arm group label: LEO 90100 foam vehicle
arm group label: Locoid®
intervention type: Drug
intervention name: Elocon
arm group label: Dermoval®/Dermovate®
arm group label: Diprosone®
arm group label: Elocon®
arm group label: LEO 90100 aerosol foam
arm group label: LEO 90100 foam vehicle
arm group label: Locoid®
intervention type: Drug
intervention name: Locoid
arm group label: Dermoval®/Dermovate®
arm group label: Diprosone®
arm group label: Elocon®
arm group label: LEO 90100 aerosol foam
arm group label: LEO 90100 foam vehicle
arm group label: Locoid®
intervention type: Other
intervention name: LEO 90100 foam vehicle
arm group label: Dermoval®/Dermovate®
arm group label: Diprosone®
arm group label: Elocon®
arm group label: LEO 90100 aerosol foam
arm group label: LEO 90100 foam vehicle
arm group label: Locoid®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Clobetasol
mesh term: Betamethasone-17,21-dipropionate
sharing ipd: No