<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/NCT02235480</url>
  </required_header>
  <id_info>
    <org_study_id>H 573 000 1307</org_study_id>
    <secondary_id>2013-004519-28</secondary_id>
    <nct_id>NCT02235480</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Tazarotene Gel in Nail Psoriasis</brief_title>
  <official_title>A Phase II Trial to Evaluate the Anti-psoriatic Efficacy and Tolerability of Tazarotene in a Gel Formulation in Patients With Mild to Moderate Nail Psoriasis - Parallel Group Comparison</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Almirall, S.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Almirall, S.A.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to determine the efficacy and safety of topical application of the&#xD;
      gel compared to placebo in nail psoriasis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2014</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>% reduction in the Nail Psoriasis Severity Index ( NAPSI )</measure>
    <time_frame>Day85</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>Day 85</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Nail Psoriasis</condition>
  <arm_group>
    <arm_group_label>Tazarotene Gel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Gel</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>once daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Experimental Tazarotene Gel</intervention_name>
    <arm_group_label>Tazarotene Gel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo Gel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Key inclusion criteria:&#xD;
&#xD;
          -  Mild to moderate nail psoriasis on at least one fingernail&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Key exclusion criteria:&#xD;
&#xD;
          -  any other skin condition, with a potential to affect the nails or to interfere with&#xD;
             evaluation of the disease;&#xD;
&#xD;
          -  history of hypersensitivity to retinoids or to other components of the trial&#xD;
             medication&#xD;
&#xD;
          -  topical treatment of nails with antipsoriatics in the 4 weeks preceding the treatment&#xD;
             phase;&#xD;
&#xD;
          -  systemic treatment of psoriasis within the three months before the treatment phase of&#xD;
             the trial or during the trial&#xD;
&#xD;
          -  intralesional steroid injection before the treatment phase of the trial&#xD;
&#xD;
          -  phototherapy before the treatment phase of the trial;&#xD;
&#xD;
          -  any chronic infection or condition capable of interfering with the conduct of the&#xD;
             trial;&#xD;
&#xD;
          -  evidence of drug or alcohol abuse;&#xD;
&#xD;
          -  symptoms of a clinically significant illness that may influence the outcome of the&#xD;
             trial in the four weeks preceding the treatment phase of the trial;&#xD;
&#xD;
          -  participation in another clinical trial within the last 4 weeks prior to first&#xD;
             treatment in this clinical trial;&#xD;
&#xD;
          -  pregnancy or nursing;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Investigational site 3</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational site 4</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational 2</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational site 1</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>March 31, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>June 9, 2015</last_update_submitted>
  <last_update_submitted_qc>June 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 10, 2015</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>Tazarotene</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02235480
org study id: H 573 000 1307
secondary id: 2013-004519-28
nct id: NCT02235480
lead sponsor: 
has dmc: No
The aim of this study is to determine the efficacy and safety of topical application of the
      gel compared to placebo in nail psoriasis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: % reduction in the Nail Psoriasis Severity Index ( NAPSI )
time frame: Day85
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: Day 85
arm group label: Tazarotene Gel
arm group type: Experimental
description: once daily
arm group label: Placebo Gel
arm group type: Placebo Comparator
description: once daily
intervention type: Drug
intervention name: Experimental Tazarotene Gel
arm group label: Tazarotene Gel
intervention type: Drug
intervention name: Placebo
arm group label: Placebo Gel
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Tazarotene