<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/NCT02995473</url>
  </required_header>
  <id_info>
    <org_study_id>RD.03.SPR.100535</org_study_id>
    <nct_id>NCT02995473</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of NP000888 in Subjects With Plaque and Nail Psoriasis</brief_title>
  <official_title>Multi-center, Randomized, Vehicle-controlled, Investigator-blinded, Parallel Groups Study to Evaluate the Efficacy and Safety of NP000888 in Subjects With Plaque and Nail 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to evaluate the efficacy and safety of topical application of NP000888 ointment&#xD;
      compared to vehicle in plaque and fingernail psoriasis subjects.&#xD;
&#xD;
      Duration of administration: 24 weeks&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 8, 2017</start_date>
  <completion_date type="Actual">May 28, 2018</completion_date>
  <primary_completion_date type="Actual">May 3, 2018</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success rate in IGA score (clear or almost clear)</measure>
    <time_frame>Baseline - Week 12</time_frame>
    <description>Success rate in IGA score (clear or almost clear)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent change from baseline in total mtNAPSI scores</measure>
    <time_frame>Baseline - Week 24</time_frame>
    <description>Mean percent change from baseline in total mtNAPSI scores</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>NP000888</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pharmaceutical form: Ointment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Pharmaceutical form: Ointment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NP000888</intervention_name>
    <description>270 µg/g topical (BID) for 24 weeks</description>
    <arm_group_label>NP000888</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vehicle</intervention_name>
    <description>Topical (BID) for 24 weeks</description>
    <arm_group_label>Vehicle</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject with a clinical diagnosis of plaque psoriasis defined as an IGA score at least&#xD;
             2 (mild) at Screening and Baseline visits&#xD;
&#xD;
          -  Subject with a plaque psoriasis total Body Surface Area (BSA) involvement of at least&#xD;
             equal to 3% but less than 20% at Screening and Baseline visits&#xD;
&#xD;
          -  Subject with a clinical diagnosis of fingernail psoriasis on at least 1 fingernail&#xD;
             with a fingernail PGA score from 2 (mild) to 4 (severe) at Screening and Baseline&#xD;
             visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject with guttata, erythrodermic, exfoliative, inverse, pustular or palmo plantar,&#xD;
             infected or ulcerated psoriasis or psoriasis involvement &gt;=20% BSA or an unstable form&#xD;
             of psoriasis, defined as at least one flare in the previous month before Screening&#xD;
             visit&#xD;
&#xD;
          -  Subject with chronic plaque psoriasis who are candidates for systemic therapy at&#xD;
             Screening and Baseline visits&#xD;
&#xD;
          -  Subject with clinical signs of psoriatic arthritis at Screening and Baseline visits&#xD;
&#xD;
          -  Subject with a clinical diagnosis of fingernail psoriasis on at least 1 fingernail&#xD;
             with a nail-PGA score from 2 (mild) to 4 (severe) at Screening and Baseline visits.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Lincuo</city>
        <state>Taoyuan</state>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma investigational site</name>
      <address>
        <city>New Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma investigational site</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma investigational site</name>
      <address>
        <city>Tainan</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma investigational site 1</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma investigational site 2</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma investigational site 3</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma investigational site 4</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma investigational site 5</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma investigational site 6</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>June 11, 2018</last_update_submitted>
  <last_update_submitted_qc>June 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Psoriasis</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/NCT02995473
org study id: RD.03.SPR.100535
nct id: NCT02995473
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is to evaluate the efficacy and safety of topical application of NP000888 ointment
      compared to vehicle in plaque and fingernail psoriasis subjects.

      Duration of administration: 24 weeks
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Success rate in IGA score (clear or almost clear)
time frame: Baseline - Week 12
description: Success rate in IGA score (clear or almost clear)
measure: Percent change from baseline in total mtNAPSI scores
time frame: Baseline - Week 24
description: Mean percent change from baseline in total mtNAPSI scores
arm group label: NP000888
arm group type: Experimental
description: Pharmaceutical form: Ointment
arm group label: Vehicle
arm group type: Placebo Comparator
description: Pharmaceutical form: Ointment
intervention type: Drug
intervention name: NP000888
description: 270 µg/g topical (BID) for 24 weeks
arm group label: NP000888
intervention type: Drug
intervention name: Vehicle
description: Topical (BID) for 24 weeks
arm group label: Vehicle
other name: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Psoriasis
sharing ipd: No