<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/NCT03025282</url>
  </required_header>
  <id_info>
    <org_study_id>RD.03.SPR.112075</org_study_id>
    <nct_id>NCT03025282</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of CD10367 in Psoriasis Vulgaris</brief_title>
  <official_title>Exploratory Study to Evaluate the Safety and Efficacy of CD10367 in Subjects With Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Galderma R&amp;D</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Galderma R&amp;D</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an exploratory, single-centre, investigator blinded, randomized, controlled,&#xD;
      intra-individual study, involving subjects with psoriasis vulgaris.&#xD;
&#xD;
      The objective is to evaluate, in a modified Dumas-Scholtz psoriasis mini-zone test, the&#xD;
      safety and efficacy of CD10367 solution at 1% and 3% after a 3-week treatment period of once&#xD;
      daily application.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study drugs will be applied in each subject once daily, 5 days a week during the first 2&#xD;
      weeks and for 4 days the third week on 6 mini-zones located on at least 2 psoriatic plaques&#xD;
      as described below:&#xD;
&#xD;
        -  on 2 mini-zones pretreated by a keratolytic product, will be tested:&#xD;
&#xD;
             -  CD10367 3% solution&#xD;
&#xD;
             -  CD10367 solution placebo&#xD;
&#xD;
        -  on 4 mini-zones non-pretreated, will be tested:&#xD;
&#xD;
             -  CD10367 3% solution&#xD;
&#xD;
             -  CD10367 1% solution&#xD;
&#xD;
             -  CD10367 solution placebo&#xD;
&#xD;
             -  Betneval 0.1% ointment&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 3, 2016</start_date>
  <completion_date type="Actual">March 24, 2017</completion_date>
  <primary_completion_date type="Actual">March 24, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the Curve (AUC) of Total Sum Score (sum of erythema, scaling and induration scores) from Baseline to Day 19</measure>
    <time_frame>Baseline to Day 19</time_frame>
    <description>Investigator's rating of the clinical appearance of each psoriatic mini-zone.&#xD;
The single items erythema, scaling, and induration (maximum score 4 each) are summed to obtain the Total Sum Score. Maximum score is 12 (very severe); minimum score is 0 (None).</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Psoriasis Vulgaris</condition>
  <arm_group>
    <arm_group_label>CD10367 3% Solution - Non-desquamated zone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>CD10367 1% Solution - Non-desquamated zone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>CD10367 solution placebo - Non-desquamated zone</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>CD10367 solution placebo serves as negative control.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Betneval ointment - Non-desquamated zone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This comparator containing Betamethasone valerate 0.1% serves as positive control.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CD10367 3% Solution - Desquamated zone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>CD10367 solution placebo - Desquamated zone</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CD10367 3% Solution - Non-desquamated zone</intervention_name>
    <description>Once daily application for 3 weeks</description>
    <arm_group_label>CD10367 3% Solution - Non-desquamated zone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CD10367 1% Solution - Non-desquamated zone</intervention_name>
    <description>Once daily application for 3 weeks</description>
    <arm_group_label>CD10367 1% Solution - Non-desquamated zone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CD10367 solution placebo - Non-desquamated zone</intervention_name>
    <description>Once daily application for 3 weeks</description>
    <arm_group_label>CD10367 solution placebo - Non-desquamated zone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Betneval ointment - Non-desquamated zone</intervention_name>
    <description>Once daily application for 3 weeks</description>
    <arm_group_label>Betneval ointment - Non-desquamated zone</arm_group_label>
    <other_name>Betamethasone Valerate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CD10367 3% Solution - Desquamated zone</intervention_name>
    <description>Once daily application for 3 weeks</description>
    <arm_group_label>CD10367 3% Solution - Desquamated zone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CD10367 solution placebo - Desquamated zone</intervention_name>
    <description>Once daily application for 3 weeks</description>
    <arm_group_label>CD10367 solution placebo - Desquamated zone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult male or female aged at least 18 and up to 70 years old inclusive at screening&#xD;
             visit.&#xD;
&#xD;
          2. Female of non childbearing potential (postmenopausal [absence of menstrual bleeding&#xD;
             for 1 year prior to screening, without any other medical reason], hysterectomy or&#xD;
             bilateral oophorectomy).&#xD;
&#xD;
          3. Subject has a skin phototype I to IV on Fitzpatrick's scale. (Screening visit).&#xD;
&#xD;
          4. The subject has a clinical diagnosis of stable plaque psoriasis, defined as no flare&#xD;
             during the month before Screening visit and no change between Screening visit and&#xD;
             Baseline visit, of mild to moderate severity. (Screening visit and Baseline Visit).&#xD;
&#xD;
          5. The subject presents with at least six eligible mini-zones, on at least two psoriasis&#xD;
             plaques (Screening visit and verified also at Baseline Visit) with specific severity&#xD;
             grades,&#xD;
&#xD;
          6. Subject agrees not to wear his/her contact lenses from the Baseline visit till the D19&#xD;
             visit, (Screening visit)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The subject presents guttate, erythrodermic, exfoliative, inverse, pustular, palmo&#xD;
             plantar, infected or ulcerated psoriasis (Screening visit).&#xD;
&#xD;
          2. The subject has any uncontrolled or serious disease, or any medical or surgical&#xD;
             condition, that may either interfere with the interpretation of the clinical trial&#xD;
             results, and/or put the subject at significant risk (according to Investigator's&#xD;
             judgment) if he/she participates in the clinical trial (e.g. history of on-going&#xD;
             gastric or duodenal ulcer, clinically significant lung disease, etc.) (Screening&#xD;
             visit).&#xD;
&#xD;
          3. The subject has known or suspected allergies or sensitivities to any components of the&#xD;
             study drugs or of the keratolytic product (see Investigator's Brochure/Product label).&#xD;
             (Screening visit).&#xD;
&#xD;
          4. The subject has known history of adverse drug reaction or hypersensitivity to a&#xD;
             product with the same mode of action&#xD;
&#xD;
          5. The subject has any abnormal clinically significant findings according to the&#xD;
             ophthalmologist, at the ophthalmological exam at Screening visit,&#xD;
&#xD;
          6. The subject presents any abnormal laboratory tests judged clinically significant by&#xD;
             the investigator (blood samplings and urinalysis done at Screening visit),&#xD;
&#xD;
          7. The subject has QTc interval &gt;450msec or any abnormal ECG value considered as&#xD;
             clinically significant by the cardiologist (Screening visit).&#xD;
&#xD;
          8. The subject has received, applied or taken some specified treatments within the&#xD;
             specified time frame prior to the Baseline visit.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>April 4, 2017</last_update_submitted>
  <last_update_submitted_qc>April 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 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>Betamethasone</mesh_term>
    <mesh_term>Betamethasone Valerate</mesh_term>
    <mesh_term>Pharmaceutical Solutions</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>June 30, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03025282
org study id: RD.03.SPR.112075
nct id: NCT03025282
lead sponsor: 
has dmc: No
This is an exploratory, single-centre, investigator blinded, randomized, controlled,
      intra-individual study, involving subjects with psoriasis vulgaris.

      The objective is to evaluate, in a modified Dumas-Scholtz psoriasis mini-zone test, the
      safety and efficacy of CD10367 solution at 1% and 3% after a 3-week treatment period of once
      daily application.
Study drugs will be applied in each subject once daily, 5 days a week during the first 2
      weeks and for 4 days the third week on 6 mini-zones located on at least 2 psoriatic plaques
      as described below:

        -  on 2 mini-zones pretreated by a keratolytic product, will be tested:

             -  CD10367 3% solution

             -  CD10367 solution placebo

        -  on 4 mini-zones non-pretreated, will be tested:

             -  CD10367 3% solution

             -  CD10367 1% solution

             -  CD10367 solution placebo

             -  Betneval 0.1% ointment
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Area Under the Curve (AUC) of Total Sum Score (sum of erythema, scaling and induration scores) from Baseline to Day 19
time frame: Baseline to Day 19
description: Investigator's rating of the clinical appearance of each psoriatic mini-zone.
The single items erythema, scaling, and induration (maximum score 4 each) are summed to obtain the Total Sum Score. Maximum score is 12 (very severe); minimum score is 0 (None).
arm group label: CD10367 3% Solution - Non-desquamated zone
arm group type: Experimental
arm group label: CD10367 1% Solution - Non-desquamated zone
arm group type: Experimental
arm group label: CD10367 solution placebo - Non-desquamated zone
arm group type: Placebo Comparator
description: CD10367 solution placebo serves as negative control.
arm group label: Betneval ointment - Non-desquamated zone
arm group type: Active Comparator
description: This comparator containing Betamethasone valerate 0.1% serves as positive control.
arm group label: CD10367 3% Solution - Desquamated zone
arm group type: Experimental
arm group label: CD10367 solution placebo - Desquamated zone
arm group type: Placebo Comparator
intervention type: Drug
intervention name: CD10367 3% Solution - Non-desquamated zone
description: Once daily application for 3 weeks
arm group label: CD10367 3% Solution - Non-desquamated zone
intervention type: Drug
intervention name: CD10367 1% Solution - Non-desquamated zone
description: Once daily application for 3 weeks
arm group label: CD10367 1% Solution - Non-desquamated zone
intervention type: Drug
intervention name: CD10367 solution placebo - Non-desquamated zone
description: Once daily application for 3 weeks
arm group label: CD10367 solution placebo - Non-desquamated zone
intervention type: Drug
intervention name: Betneval ointment - Non-desquamated zone
description: Once daily application for 3 weeks
arm group label: Betneval ointment - Non-desquamated zone
other name: Betamethasone Valerate
intervention type: Drug
intervention name: CD10367 3% Solution - Desquamated zone
description: Once daily application for 3 weeks
arm group label: CD10367 3% Solution - Desquamated zone
intervention type: Drug
intervention name: CD10367 solution placebo - Desquamated zone
description: Once daily application for 3 weeks
arm group label: CD10367 solution placebo - Desquamated zone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Betamethasone
mesh term: Betamethasone Valerate
mesh term: Pharmaceutical Solutions
submitted: June 30, 2023