<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/NCT01670513</url>
  </required_header>
  <id_info>
    <org_study_id>DPSI-IDP-118-P2-01</org_study_id>
    <nct_id>NCT01670513</nct_id>
  </id_info>
  <brief_title>A Phase 2 Dose Ranging, Evaluator-Blinded Study to Evaluate the Safety of Topical IDP-118</brief_title>
  <acronym>IDP-118</acronym>
  <official_title>A Phase 2 Dose Ranging, Evaluator-Blinded Study to Evaluate the Safety of Topical IDP-118</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dow Pharmaceutical Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dow Pharmaceutical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Subjects with a clinical diagnosis of plaque psoriasis with 10% to 20% of body surface area&#xD;
      affected will be enrolled in the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately 60 subjects with a clinical diagnosis of moderate or severe psoriasis (defined&#xD;
      as at least of 10 % - 20% treatable Body Surface Area (BSA) and an Investigator's Global&#xD;
      Evaluation (IGE) of 3 or 4 at baseline (moderate or severe) will be enrolled in the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>June 2012</start_date>
  <completion_date type="Anticipated">July 2013</completion_date>
  <primary_completion_date type="Anticipated">May 2013</primary_completion_date>
  <phase>Phase 1/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>The incidence of HPA axis suppression after treatment with investigational drug product and the comparators</measure>
    <time_frame>8 weeks</time_frame>
    <description>To measure the incidence of HPA axis suppression after treatment with investigational drug product and the comparators</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the safety and cutaneous tolerability of the two formulations and the comparators</measure>
    <time_frame>8 weeks</time_frame>
    <description>To evaluate and Local Skin Reactions: Tolerability will be evaluated through assessment of selected local signs and symptoms at the drug-application site: itching, dryness, burning and stinging. In addition the treatment areas will be examined at each visit for significant known drug-related AEs such as skin atrophy, striae, telangiectasia and folliculitis.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>To evaluate efficacy, defined as reduction of severity of disease in a sample target plaque during the course of the study</measure>
    <time_frame>8 weeks</time_frame>
    <description>The Investigator will assess the target lesion site affected by psoriasis at each visit. Areas affected by psoriasis (at a minimum 10% BSA) are to be treated with study drug</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Plaque Psoriasis</condition>
  <arm_group>
    <arm_group_label>IDP-118 Low Strength</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IDP-118 Low Strength</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IDP-118 High Strength</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IDP-118 High Strength</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IDP-118 Low Strength</intervention_name>
    <description>8 weeks</description>
    <arm_group_label>IDP-118 Low Strength</arm_group_label>
    <other_name>IDP-118</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IDP-118 High Strength</intervention_name>
    <description>8 weeks</description>
    <arm_group_label>IDP-118 High Strength</arm_group_label>
    <other_name>IDP-118</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female of any race, 18 to 65 (inclusive) years of age.&#xD;
&#xD;
          -  Freely given verbal and written informed consent obtained from the subject.&#xD;
&#xD;
          -  Clinical diagnosis of psoriasis at the Screening and Baseline visits with&#xD;
&#xD;
          -  At least 10% - 20% of total treatable BSA involvement, and&#xD;
&#xD;
          -  an Investigator's Global Evaluation score of 3 or 4 ( moderate or severe) on a scale&#xD;
             of 0 to 5&#xD;
&#xD;
          -  Good general health as determined by the Investigator based on the subject's medical&#xD;
             history and physical examination, with Screening hematology, serum chemistry, and&#xD;
             urinalysis laboratory values within normal range limits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of psoriasis that was previously treated with prescription medication prior&#xD;
             to the Screening visit and is non-responsive to corticosteroid treatment, as&#xD;
             determined by the Investigator.&#xD;
&#xD;
          -  Presence of any concurrent skin condition that could interfere with the evaluation of&#xD;
             the study drug, as determined by the Investigator.&#xD;
&#xD;
          -  History of adrenal disease&#xD;
&#xD;
          -  Female who is pregnant, nursing an infant, or planning a pregnancy during the study&#xD;
             period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Todd Plott, MD</last_name>
    <role>Study Director</role>
    <affiliation>Medical Monitor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dow Clinical Study Site</name>
      <address>
        <city>Santa Rosa</city>
        <state>California</state>
        <zip>95403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dow Clinical Study Site</name>
      <address>
        <city>Clinton Township</city>
        <state>Michigan</state>
        <zip>48038</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dow Cliincal Study Site</name>
      <address>
        <city>Fort Gratiot</city>
        <state>Michigan</state>
        <zip>48059</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dow Clinical Study Site</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dow Clinical Study Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78759</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dow Clinical Study Site</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>May 31, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>April 23, 2013</last_update_submitted>
  <last_update_submitted_qc>April 23, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 25, 2013</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>
  <!-- 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/NCT01670513
org study id: DPSI-IDP-118-P2-01
nct id: NCT01670513
lead sponsor: 
has dmc: No
Subjects with a clinical diagnosis of plaque psoriasis with 10% to 20% of body surface area
      affected will be enrolled in the study.
Approximately 60 subjects with a clinical diagnosis of moderate or severe psoriasis (defined
      as at least of 10 % - 20% treatable Body Surface Area (BSA) and an Investigator's Global
      Evaluation (IGE) of 3 or 4 at baseline (moderate or severe) will be enrolled in the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: The incidence of HPA axis suppression after treatment with investigational drug product and the comparators
time frame: 8 weeks
description: To measure the incidence of HPA axis suppression after treatment with investigational drug product and the comparators
measure: To evaluate the safety and cutaneous tolerability of the two formulations and the comparators
time frame: 8 weeks
description: To evaluate and Local Skin Reactions: Tolerability will be evaluated through assessment of selected local signs and symptoms at the drug-application site: itching, dryness, burning and stinging. In addition the treatment areas will be examined at each visit for significant known drug-related AEs such as skin atrophy, striae, telangiectasia and folliculitis.
measure: To evaluate efficacy, defined as reduction of severity of disease in a sample target plaque during the course of the study
time frame: 8 weeks
description: The Investigator will assess the target lesion site affected by psoriasis at each visit. Areas affected by psoriasis (at a minimum 10% BSA) are to be treated with study drug
arm group label: IDP-118 Low Strength
arm group type: Experimental
description: IDP-118 Low Strength
arm group label: IDP-118 High Strength
arm group type: Experimental
description: IDP-118 High Strength
intervention type: Drug
intervention name: IDP-118 Low Strength
description: 8 weeks
arm group label: IDP-118 Low Strength
other name: IDP-118
intervention type: Drug
intervention name: IDP-118 High Strength
description: 8 weeks
arm group label: IDP-118 High Strength
other name: IDP-118
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Todd Plott, MD
role: Study Director
affiliation: Medical Monitor
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Psoriasis