<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/NCT01703793</url>
  </required_header>
  <id_info>
    <org_study_id>MP-1001-01</org_study_id>
    <nct_id>NCT01703793</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study in Subjects With Seborrheic Dermatitis</brief_title>
  <official_title>A Parallel-group, Vehicle-controlled, Randomized, Double-blind Study of the Efficacy and Safety of Product 49778 and Product 10156 in Subjects With Seborrheic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medicis Global Service Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medicis Global Service Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if two test products are safe and effective in the&#xD;
      treatment of seborrheic dermatitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</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>Symptom Improvement (investigator assessment)</measure>
    <time_frame>Week 4</time_frame>
    <description>Proportion of subjects with a response of clear or almost clear, and at least a two-grade improvement from baseline to week 4</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symptom Improvement (subject assessment)</measure>
    <time_frame>Weeks 2 and 4</time_frame>
    <description>Assess the change in the pruritus score from baseline to week 2 and to week 4.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>Seborrheic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Vehicle (placebo) treatment, twice a week for four weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test Product 10156</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Product 10156 treatment, twice a week for four weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test Product 49778</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Product 49778 treatment, twice a week for four weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Test Product 49778</intervention_name>
    <arm_group_label>Test Product 49778</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Test Product 10156</intervention_name>
    <arm_group_label>Test Product 10156</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vehicle (placebo)</intervention_name>
    <arm_group_label>Vehicle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Investigator assessment of seborrheic dermatitis.&#xD;
&#xD;
          -  Additional criteria as identified in the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of or ongoing psoriasis of the scalp.&#xD;
&#xD;
          -  History of or ongoing atopic dermatitis of the scalp.&#xD;
&#xD;
          -  Additional criteria as identified in the protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ira Lawrence, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Medicis Pharmaceutical</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Fremont</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Snellville</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fridley</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Paramus</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mount Kisco</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>College Station</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Webster</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>October 7, 2012</study_first_submitted>
  <study_first_submitted_qc>October 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>January 7, 2013</last_update_submitted>
  <last_update_submitted_qc>January 7, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2013</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>Dermatitis</mesh_term>
    <mesh_term>Dermatitis, Seborrheic</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/NCT01703793
org study id: MP-1001-01
nct id: NCT01703793
lead sponsor: 
has dmc: No
The purpose of this study is to determine if two test products are safe and effective in the
      treatment of seborrheic dermatitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Symptom Improvement (investigator assessment)
time frame: Week 4
description: Proportion of subjects with a response of clear or almost clear, and at least a two-grade improvement from baseline to week 4
measure: Symptom Improvement (subject assessment)
time frame: Weeks 2 and 4
description: Assess the change in the pruritus score from baseline to week 2 and to week 4.
arm group label: Vehicle
arm group type: Placebo Comparator
description: Vehicle (placebo) treatment, twice a week for four weeks.
arm group label: Test Product 10156
arm group type: Experimental
description: Product 10156 treatment, twice a week for four weeks.
arm group label: Test Product 49778
arm group type: Experimental
description: Product 49778 treatment, twice a week for four weeks.
intervention type: Drug
intervention name: Test Product 49778
arm group label: Test Product 49778
intervention type: Drug
intervention name: Test Product 10156
arm group label: Test Product 10156
intervention type: Drug
intervention name: Vehicle (placebo)
arm group label: Vehicle
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
last name: Ira Lawrence, MD
role: Study Chair
affiliation: Medicis Pharmaceutical
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dermatitis
mesh term: Dermatitis, Seborrheic