<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/NCT01714544</url>
  </required_header>
  <id_info>
    <org_study_id>CDC1201</org_study_id>
    <nct_id>NCT01714544</nct_id>
  </id_info>
  <brief_title>Study of the Efficacy of Cloderm® Cream in the Treatment of Moderate Plaque Psoriasis</brief_title>
  <official_title>An Open-Label, Multicenter Study of the Efficacy of Cloderm® Cream (Clocortolone Pivalate, 0.1%) in the Treatment of Moderate Plaque Psoriasis for 28 Days</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Promius Pharma, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Promius Pharma, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether Cloderm Cream is effective for topical&#xD;
      treatment of moderate psoriasis over 28 days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to estimate the efficacy of Cloderm Cream for topical&#xD;
      treatment of moderate plaque psoriasis over 28 days using current standards for evaluation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Investigator's Global Assessment (IGA)</measure>
    <time_frame>28 days</time_frame>
    <description>The proportion of subjects who demonstrate an IGA score of clear (0) or almost clear (1).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Cloderm Cream</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cloderm Cream</intervention_name>
    <arm_group_label>Cloderm Cream</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject understands the study procedures and agrees to participate by giving written&#xD;
             informed consent.&#xD;
&#xD;
          2. Subjects must be at least 18 years of age.&#xD;
&#xD;
          3. Subjects must present with a clinical diagnosis of stable (at least 3 months)&#xD;
             plaque-type psoriasis.&#xD;
&#xD;
          4. Subjects with psoriasis involving 2 to 20% BSA, not including the face, scalp and&#xD;
             intertriginous areas.&#xD;
&#xD;
          5. Subjects must have an IGA Grade of 3 at the Baseline Visit.&#xD;
&#xD;
          6. Female subjects of childbearing potential must have a negative urine pregnancy test&#xD;
             result at Baseline (Visit 2) (test will have a sensitivity of at least 25mIU/ml for&#xD;
             human chorionic gonadotropin) and practice a reliable method of contraception or&#xD;
             remain sexually inactive throughout the study.&#xD;
&#xD;
             All women of childbearing potential must be willing to undergo a urine pregnancy test&#xD;
             at Visit 2 (Day 0), at Visit 4 (Day 14), and at Visit 5 (Day 28).&#xD;
&#xD;
          7. Subjects must be in good general health as determined by the investigator and&#xD;
             supported by the medical history and normal or not clinically significant abnormal&#xD;
             vital signs (blood pressure and pulse).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic,&#xD;
             exfoliative or pustular psoriasis.&#xD;
&#xD;
          2. Other inflammatory skin disease that may confound the evaluation of the plaque&#xD;
             psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).&#xD;
&#xD;
          3. Presence of pigmentation, extensive scarring, pigmented lesions or sunburn which could&#xD;
             interfere with the rating of efficacy parameters.&#xD;
&#xD;
          4. History of psoriasis unresponsive to topical treatments.&#xD;
&#xD;
          5. History of organ transplant requiring immunosuppression, HIV, or other&#xD;
             immunocompromised state.&#xD;
&#xD;
          6. Use within 180 days prior to Baseline Visit of biologic treatment for psoriasis (e.g.,&#xD;
             infliximab, adalimumab, etanercept, ustekinumab, or alefacept).&#xD;
&#xD;
          7. Have received treatment for any type of cancer within 5 years of the Baseline Visit&#xD;
             except for non-melanoma skin cancer and cervical cancer (in situ) are allowed within 1&#xD;
             year of the Baseline Visit.&#xD;
&#xD;
          8. Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g.,&#xD;
             tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate,&#xD;
             cyclosporine, hydroxyurea) or 3) oral retinoids (e.g., acitretin, isotretinoin).&#xD;
&#xD;
          9. Use within 30 days prior to the Baseline Visit of: 1) systemic steroids, 2) PUVA&#xD;
             therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil,&#xD;
             sulfasalazine, 6-thioguanine), or 4) UVB therapy. Note: Inhaled, intraocular and&#xD;
             intranasal steroids are allowed.&#xD;
&#xD;
         10. Use within 14 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs&#xD;
             (e.g., salicylic acid, anthralin, coal tar, calcipotriene), 2) topical retinoids&#xD;
             (e.g., tazarotene, tretinoin) or 3) topical corticosteroids.&#xD;
&#xD;
         11. Subjects with known hypersensitivity to clocortolone pivalate or any component of&#xD;
             Cloderm Cream.&#xD;
&#xD;
         12. Subjects who have participated in a study of an investigational drug 60 days prior to&#xD;
             the Baseline Visit.&#xD;
&#xD;
         13. Subjects unable to comply with study requirements.&#xD;
&#xD;
         14. Female subjects who are pregnant (or planning to become pregnant) or breast-feeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joanne M Fraser, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Promius Pharma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Radiant Research, Inc.</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Medical Research</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97223</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DermResearch, Inc.</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78759</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Across America</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Madison Skin and Research, Inc.</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53719</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <results_first_submitted>June 25, 2014</results_first_submitted>
  <results_first_submitted_qc>June 25, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 23, 2014</results_first_posted>
  <last_update_submitted>June 25, 2014</last_update_submitted>
  <last_update_submitted_qc>June 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 23, 2014</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>Clocortolone pivalate</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cloderm Cream</title>
          <description>Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days&#xD;
Cloderm Cream</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cloderm Cream</title>
          <description>Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days&#xD;
Cloderm Cream</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50" spread="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Investigator's Global Assessment (IGA)</title>
        <description>The proportion of subjects who demonstrate an IGA score of clear (0) or almost clear (1).</description>
        <time_frame>28 days</time_frame>
        <population>Intent to treat population, with LOCF for missing data</population>
        <group_list>
          <group group_id="O1">
            <title>Cloderm Cream</title>
            <description>Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days&#xD;
Cloderm Cream</description>
          </group>
        </group_list>
        <measure>
          <title>Investigator's Global Assessment (IGA)</title>
          <description>The proportion of subjects who demonstrate an IGA score of clear (0) or almost clear (1).</description>
          <population>Intent to treat population, with LOCF for missing data</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15" lower_limit="8.1" upper_limit="26.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Cloderm Cream</title>
          <description>Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days&#xD;
Cloderm Cream</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>No report, abstract, oral presentation, or publication proposed by the Investigator/Institution in regard to Study shall be presented or published without the prior written consent of the Sponsor. Sponsor reserves the right to comment on and delay the proposed report, abstract, oral presentation, or publication and to revise as necessary to protect confidential information or intellectual property.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director Clinical Operations</name_or_title>
      <organization>Promius Pharma</organization>
      <phone>609-282-1404</phone>
      <email>jfraser@drreddys.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01714544
org study id: CDC1201
nct id: NCT01714544
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether Cloderm Cream is effective for topical
      treatment of moderate psoriasis over 28 days.
The objective of this study is to estimate the efficacy of Cloderm Cream for topical
      treatment of moderate plaque psoriasis over 28 days using current standards for evaluation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Investigator's Global Assessment (IGA)
time frame: 28 days
description: The proportion of subjects who demonstrate an IGA score of clear (0) or almost clear (1).
arm group label: Cloderm Cream
arm group type: Experimental
description: Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days
intervention type: Drug
intervention name: Cloderm Cream
arm group label: Cloderm Cream
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joanne M Fraser, PhD
role: Study Director
affiliation: Promius Pharma
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Clocortolone pivalate
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 