<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/NCT01702181</url>
  </required_header>
  <id_info>
    <org_study_id>271-12-204</org_study_id>
    <nct_id>NCT01702181</nct_id>
  </id_info>
  <brief_title>A Safety Study to Evaluate the Use and Effectiveness of a Topical Ointment to Treat Adults With Atopic Dermatitis</brief_title>
  <official_title>A Multiple-Dose (0.3%, 1%, and 3% [w/w]), Randomized, Blinded, Vehicle- and Active Comparator-Controlled, Sequential Dose Cohorts, Multi-Center Trial to Assess the Safety, Pharmacokinetics, and Proof-of-Concept Efficacy of Topical OPA 15406 Ointment, Applied Twice Daily for 28 Days, in Adult Subjects With Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Otsuka Pharmaceutical Development &amp; Commercialization, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Otsuka Pharmaceutical Development &amp; Commercialization, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the pharmacokinetics and safety of OPA-15406 in&#xD;
      adult subjects with atopic dermatitis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects with AEs, SAEs, and % of clinically relevant changes from baseline in Draize Scale, physical examinations, vital signs, laboratory assessments, and electrocardiograms.</measure>
    <time_frame>28 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement of drug levels in the blood of treated patients</measure>
    <time_frame>28 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Investigator's Global Assessment (IGA) of Disease Severity at Week 4</measure>
    <time_frame>28 Days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">92</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tacrolimus</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tacrolimus 0.1% ointment twice daily for 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OPA-15406</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OPA-15406</intervention_name>
    <description>0.3%, 1%, or 3% OPA-15406 topical ointment, applied twice daily for 28 days</description>
    <arm_group_label>OPA-15406</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tacrolimus</intervention_name>
    <description>0.1% concentration of tacrolimus.</description>
    <arm_group_label>Tacrolimus</arm_group_label>
    <other_name>Protopic</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult subjects 18-65 years of age&#xD;
&#xD;
          -  Diagnosis of atopic dermatitis (AD)&#xD;
&#xD;
          -  AD affecting at least 5% of total Body Surface Area (BSA) for Part 1 and at least 10%&#xD;
             BSA for Part 2, not including face, neck, and head&#xD;
&#xD;
          -  Have had a positive but inadequate response to one or more treatment course of&#xD;
             standard AD therapy including topical steroids, UV light A, narrowband UV B, and UV&#xD;
             light B.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -Use of systemic or topical therapy for contact or atopic dermatitis within 30 days of&#xD;
        screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hot Springs</city>
        <state>Arizona</state>
        <zip>71913</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92697</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orange Park</city>
        <state>Florida</state>
        <zip>32073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Carmel</city>
        <state>Indiana</state>
        <zip>46032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Berlin</city>
        <state>New Jersey</state>
        <zip>08009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>College Station</city>
        <state>Texas</state>
        <zip>77845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>January 16, 2014</last_update_submitted>
  <last_update_submitted_qc>January 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atopic Dermatitis, Eczema</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tacrolimus</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/NCT01702181
org study id: 271-12-204
nct id: NCT01702181
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the pharmacokinetics and safety of OPA-15406 in
      adult subjects with atopic dermatitis
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of subjects with AEs, SAEs, and % of clinically relevant changes from baseline in Draize Scale, physical examinations, vital signs, laboratory assessments, and electrocardiograms.
time frame: 28 days
measure: Measurement of drug levels in the blood of treated patients
time frame: 28 days
measure: Investigator's Global Assessment (IGA) of Disease Severity at Week 4
time frame: 28 Days
arm group label: Placebo
arm group type: Placebo Comparator
description: Matching placebo.
arm group label: Tacrolimus
arm group type: Active Comparator
description: Tacrolimus 0.1% ointment twice daily for 28 days.
arm group label: OPA-15406
arm group type: Experimental
intervention type: Drug
intervention name: OPA-15406
description: 0.3%, 1%, or 3% OPA-15406 topical ointment, applied twice daily for 28 days
arm group label: OPA-15406
intervention type: Drug
intervention name: Tacrolimus
description: 0.1% concentration of tacrolimus.
arm group label: Tacrolimus
other name: Protopic
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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facility: 
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country: United States
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
mesh term: Tacrolimus