<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/NCT04459780</url>
  </required_header>
  <id_info>
    <org_study_id>CaPSO17</org_study_id>
    <nct_id>NCT04459780</nct_id>
  </id_info>
  <brief_title>Characterization and Functionality of Calcium Channels Cav1.4 of Th17 Lymphocytes in Human With Psoriasis</brief_title>
  <official_title>Characterization and Functionality of Calcium Channels Cav1.4 of Th17 Lymphocytes in Human With Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pierre Fabre Dermo Cosmetique</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre National de la Recherche Scientifique, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Pierre Fabre Dermo Cosmetique</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      It's clearly known that lymphocyte activation in particular Th17 response, plays a major role&#xD;
      in the development of plaque psoriasis. New therapies targeting this pathway are showing&#xD;
      great clinical efficacy in patients with moderate to severe plaque psoriasis.&#xD;
&#xD;
      Pioneering observations have shown that the expression of Cav1.4 channels in Th17 lymphocytes&#xD;
      and they're functional role is supported by the inhibition of IL-17 production by a&#xD;
      pharmacological inhibitor of Cav1 channels that is effective in a mouse model of Psoriasis.&#xD;
&#xD;
      This data strongly suggest that the Cav1.4 channel, via its involvement in the signalling&#xD;
      responsible for the production of Th17 cytokines represents an interesting therapeutic target&#xD;
      in Psoriasis.&#xD;
&#xD;
      The aim of the study is to explore biological functions related to the activation of the&#xD;
      Cav1.4 pathway in Psoriasis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Evaluate the expression of Cav1.4 calcium channels by Th17 lymphocytes from plaque&#xD;
           psoriasis.&#xD;
&#xD;
        -  To assess:&#xD;
&#xD;
             -  The role of Cav1.4 channels on the activation of Th17 lymphocytes&#xD;
&#xD;
             -  The transcriptomic signature relating to the signalling channel Cav1.4&#xD;
&#xD;
             -  The epigenetic signature, in particular changes in overall methylation and specific&#xD;
                promoter methylation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 25, 2016</start_date>
  <completion_date type="Actual">November 13, 2017</completion_date>
  <primary_completion_date type="Actual">November 13, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Monocentric, open-label, comparative, parallel group and intra-individual patho-physiological study :&#xD;
Group 1 : 20 subjects with plaque psoriasis&#xD;
Group 2 : 10 subject with atopic dermatitis</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Expression of Cav1.4 calcium channels in Th17 lymphocytes</measure>
    <time_frame>Baseline</time_frame>
    <description>Immunohistochemistry (IHC) and in situ hybridation (HIS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Role of Cav1.4 channels on the activation of Th17 lymphocytes</measure>
    <time_frame>Baseline</time_frame>
    <description>Fonctional study : intracellular marquing and qPCR (with TLDA technology (TaqMan Low Density Arrrays)) and ELISA method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transcriptomic signature relating to the signaling channel Cav1.4</measure>
    <time_frame>Baseline</time_frame>
    <description>qPCR with TLDA technology (TaqMan Low Density Arrrays)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epigenetic signature, in particular changes in overall methylation and specific promoter methylation</measure>
    <time_frame>Baseline</time_frame>
    <description>Pyrosequencing</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Group 1 : 20 subjects with plaque psoriasis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: skin biopsies and blood sample</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 : 10 subjects with atopic dermatitis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: skin biopsies</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Skin biopsies</intervention_name>
    <description>3 biopsies on lesion skin (and one more for the first fifteen subjects in group 1)</description>
    <arm_group_label>Group 1 : 20 subjects with plaque psoriasis</arm_group_label>
    <arm_group_label>Group 2 : 10 subjects with atopic dermatitis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>One blood sample for the group 1 only.</description>
    <arm_group_label>Group 1 : 20 subjects with plaque psoriasis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Group 1 : Subject with plaque psoriasis (diagnosis confirmed by dermatologist) with a&#xD;
             plaque IGA score ≥ 3&#xD;
&#xD;
          -  Group 2 : Subject with atopic dermatitis according to the UK Working party criteria&#xD;
             with an IGA plaque score ≥3&#xD;
&#xD;
        Exlusion Criteria:&#xD;
&#xD;
          -  Group 1 : Other chronic inflammatory dermatosis than plaque psoriasis at the sites to&#xD;
             be sampled&#xD;
&#xD;
          -  Group 2 : Other chronic inflammatory dermatosis than Atopic Dermatitis at the sites to&#xD;
             be sampled&#xD;
&#xD;
          -  For both groups: Ongoing treatment with calcium channel blockers&#xD;
&#xD;
          -  For both groups: Any current topical treatment on the biopsied or systemic plaque for&#xD;
             psoriasis or AD (including phototherapy)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul CARL, Pr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Service de Dermatologie - Hôpital Larrey</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service de Dermatologie - Hôpital Larrey</name>
      <address>
        <city>Toulouse</city>
        <zip>31400</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 10, 2020</last_update_submitted>
  <last_update_submitted_qc>July 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Th17</keyword>
  <keyword>Cav1.4</keyword>
  <keyword>Lymphocyte</keyword>
  <keyword>Channel</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_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/NCT04459780
org study id: CaPSO17
nct id: NCT04459780
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It's clearly known that lymphocyte activation in particular Th17 response, plays a major role
      in the development of plaque psoriasis. New therapies targeting this pathway are showing
      great clinical efficacy in patients with moderate to severe plaque psoriasis.

      Pioneering observations have shown that the expression of Cav1.4 channels in Th17 lymphocytes
      and they're functional role is supported by the inhibition of IL-17 production by a
      pharmacological inhibitor of Cav1 channels that is effective in a mouse model of Psoriasis.

      This data strongly suggest that the Cav1.4 channel, via its involvement in the signalling
      responsible for the production of Th17 cytokines represents an interesting therapeutic target
      in Psoriasis.

      The aim of the study is to explore biological functions related to the activation of the
      Cav1.4 pathway in Psoriasis.
-  Evaluate the expression of Cav1.4 calcium channels by Th17 lymphocytes from plaque
           psoriasis.

        -  To assess:

             -  The role of Cav1.4 channels on the activation of Th17 lymphocytes

             -  The transcriptomic signature relating to the signalling channel Cav1.4

             -  The epigenetic signature, in particular changes in overall methylation and specific
                promoter methylation
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Monocentric, open-label, comparative, parallel group and intra-individual patho-physiological study :
Group 1 : 20 subjects with plaque psoriasis
Group 2 : 10 subject with atopic dermatitis
primary purpose: Basic Science
masking: None (Open Label)
measure: Expression of Cav1.4 calcium channels in Th17 lymphocytes
time frame: Baseline
description: Immunohistochemistry (IHC) and in situ hybridation (HIS)
measure: Role of Cav1.4 channels on the activation of Th17 lymphocytes
time frame: Baseline
description: Fonctional study : intracellular marquing and qPCR (with TLDA technology (TaqMan Low Density Arrrays)) and ELISA method
measure: Transcriptomic signature relating to the signaling channel Cav1.4
time frame: Baseline
description: qPCR with TLDA technology (TaqMan Low Density Arrrays)
measure: Epigenetic signature, in particular changes in overall methylation and specific promoter methylation
time frame: Baseline
description: Pyrosequencing
arm group label: Group 1 : 20 subjects with plaque psoriasis
arm group type: Experimental
description: Intervention: skin biopsies and blood sample
arm group label: Group 2 : 10 subjects with atopic dermatitis
arm group type: Experimental
description: Intervention: skin biopsies
intervention type: Biological
intervention name: Skin biopsies
description: 3 biopsies on lesion skin (and one more for the first fifteen subjects in group 1)
arm group label: Group 1 : 20 subjects with plaque psoriasis
arm group label: Group 2 : 10 subjects with atopic dermatitis
intervention type: Biological
intervention name: Blood sample
description: One blood sample for the group 1 only.
arm group label: Group 1 : 20 subjects with plaque psoriasis
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Paul CARL, Pr.
role: Principal Investigator
affiliation: Service de Dermatologie - Hôpital Larrey
facility: 
country: France
responsible party type: Sponsor
mesh term: Psoriasis
sharing ipd: No