<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/NCT01707043</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00021361</org_study_id>
    <nct_id>NCT01707043</nct_id>
  </id_info>
  <brief_title>Patient Preference of Taclonex Ointment to Taclonex Scalp Suspension in Adult Subjects With Psoriasis Vulgaris</brief_title>
  <acronym>PSTaclonex</acronym>
  <official_title>Patient Preference of Taclonex Ointment to Taclonex Scalp Suspension in Adult Subjects With Psoriasis Vulgaris</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>LEO Pharma</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open label, investigator-blinded, cross over, prospective, single center study of&#xD;
      subjects with plaque psoriasis. Taclonex® (calcipotriene 0.005% and betamethasone&#xD;
      dipropionate 0.064%) Ointment and Taclonex Scalp® (calcipotriene 0.005% and betamethasone&#xD;
      dipropionate 0.064%) Topical Suspension will each be applied topically once daily.&#xD;
&#xD;
      The primary objective is to assess the patient preference for Taclonex® (calcipotriene 0.005%&#xD;
      and betamethasone dipropionate 0.064%) Ointment compared to Taclonex Scalp® (calcipotriene&#xD;
      0.005% and betamethasone dipropionate 0.064%) Topical Suspension in the treatment of plaque&#xD;
      psoriasis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Following satisfaction of entry criteria, all subjects at the Baseline/Screening visit&#xD;
           will be randomized 1:1 to receive either Taclonex® (calcipotriene 0.005% and&#xD;
           betamethasone dipropionate 0.064%) Ointment or Taclonex Scalp® (calcipotriene 0.005% and&#xD;
           betamethasone dipropionate 0.064%) Topical Suspension to use once daily for three days&#xD;
           to affected areas of the body, excluding face and intertriginous areas. Subjects will be&#xD;
           aware of which product they are using. Investigators will remain blinded.&#xD;
&#xD;
        -  Subjects will be randomized to use either the ointment or the scalp suspension for the&#xD;
           first three day treatment period, then cross over to use the other product for second&#xD;
           three day treatment period.&#xD;
&#xD;
        -  Each medication will be used within its FDA-approved label for the treatment of plaque&#xD;
           psoriasis in subjects aged 18 and older. Subjects may not treat areas of the face,&#xD;
           axilla or groin in this study.&#xD;
&#xD;
        -  At the Day 3 and Day 6 visits the subjects will complete a questionnaire about their&#xD;
           psoriasis treatment preferences.&#xD;
&#xD;
        -  Pregnancy tests will be done on females of childbearing potential at Baseline/Screening.&#xD;
&#xD;
        -  Adverse events will be monitored at each visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Subjective Subject Preference Survey for the First Treatment Session</measure>
    <time_frame>3 days</time_frame>
    <description>Subjective Subject Preference Survey The Subjective Subject Preference Survey consist of 15 questions relating to patients preference of study drug. The survey includes questions such as how the medication feels to touch, how greasy it is, and time it takes to apply. The final question asks patients to rate the overall appeal of the vehicle. Questions are scored on a 7-point scale, where a score of 1 is extremely unpleasant, 4 is neutral, and a score of 7 is extremely appealing. Total preference score based on the Subjective Subject Preference Survey could range from 15-105.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective Subject Preference Survey for the Second Treatment Session</measure>
    <time_frame>3 days</time_frame>
    <description>Subjective Subject Preference Survey The Subjective Subject Preference Survey consist of 15 questions relating to patients preference of study drug. The survey includes questions such as how the medication feels to touch, how greasy it is, and time it takes to apply. The final question asks patients to rate the overall appeal of the vehicle. Questions are scored on a 7-point scale, where a score of 1 is extremely unpleasant, 4 is neutral, and a score of 7 is extremely appealing. Total preference score based on the Subjective Subject Preference Survey could range from 15-105.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Plaque Psoriasis</condition>
  <arm_group>
    <arm_group_label>Taclonex Ointment First</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All subjects will use Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment once daily for three days to affected areas, then switch to Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas for three days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Taclonex Scalp Suspension first</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas for three days, then switch to Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment once daily for three days to affected areas,</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Taclonex</intervention_name>
    <description>Subjects will be evaluated at baseline, Day 3 and Day 6 (or end of study).</description>
    <arm_group_label>Taclonex Ointment First</arm_group_label>
    <arm_group_label>Taclonex Scalp Suspension first</arm_group_label>
    <other_name>Taclonex® Ointment</other_name>
    <other_name>(calcipotriene 0.005% betamethasone dipropionate 0.064%)</other_name>
    <other_name>Taclonex Scalp®</other_name>
    <other_name>(calcipotriene 0.005% and betamethasone dipropionate 0.064%)</other_name>
    <other_name>Topical Suspension</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is male or female, age 18 or older, in good health.&#xD;
&#xD;
          -  Subject has plaque-type psoriasis- no history of or current pustular, erythrodermic or&#xD;
             guttate psoriasis.&#xD;
&#xD;
          -  Subject is capable of understanding and willing to provide a signed and dated written&#xD;
             voluntary informed consent before any protocol specific procedures are performed.&#xD;
&#xD;
          -  The percentage of overall body surface involvement is between 1-10% on the trunk or&#xD;
             extremities and is amenable to topical treatment with less than 100g of topical&#xD;
             medication per week.&#xD;
&#xD;
          -  The subject has an investigator global assessment of mild to moderate plaque psoriasis&#xD;
             (severity index between 2 and 3 on a 5 point scale).&#xD;
&#xD;
          -  The subject is able to complete the study and comply with study instructions,&#xD;
             including attending all study visits.&#xD;
&#xD;
          -  If a female subject of childbearing potential, subject has a negative urine pregnancy&#xD;
             test. Sexually active women of childbearing potential participating in the study must&#xD;
             have been using a medically acceptable form of contraception (which includes barrier&#xD;
             methods, oral contraception, injectable or implantable methods, or intrauterine&#xD;
             devices) for at least three months prior to entry into the study. A woman of&#xD;
             childbearing potential is defined as one who is biologically capable of becoming&#xD;
             pregnant. Abstinence is considered an acceptable method of contraception.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has used experimental drugs or devices at least one month prior to Baseline.&#xD;
&#xD;
          -  Subject has used systemic corticosteroid, phototherapy, retinoids, methotrexate,&#xD;
             cyclosporine, or other immunosuppressive agents or biologics therapy (ie, alefacept,&#xD;
             etanercept, efalizumab) within four weeks of Baseline.&#xD;
&#xD;
          -  Subject has used topical therapy, corticosteroid therapy, topical vitamin D analog or&#xD;
             calcineurin inhibitors or , tazarotene within two weeks prior to the Baseline visit&#xD;
             (eg, tar, anthralin, salicylic acid, lactic acid, urea preparations).&#xD;
&#xD;
          -  Subject has other serious skin disorder or any chronic medical condition that is not&#xD;
             well controlled.&#xD;
&#xD;
          -  Subject has clinically relevant abnormal vital signs or findings on the physical&#xD;
             examination.&#xD;
&#xD;
          -  Subject has major illness within 30 days prior to the Baseline visit.&#xD;
&#xD;
          -  Subject has history of any immunocompromising disease.&#xD;
&#xD;
          -  Subject is pregnant or nursing. Pregnant and nursing females will not be allowed in&#xD;
             the study, and females of childbearing potential will have a pregnancy test at&#xD;
             Baseline.&#xD;
&#xD;
          -  Subject has a skin condition or disease that may require concurrent therapy or may&#xD;
             confound the evaluation; a history of hypersensitivity to any of the formulation&#xD;
             components; or atopic dermatitis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steve R Feldman, M.D, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alan B Fleischer, Jr, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Adele R Clark, PA-C</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <results_first_submitted>January 27, 2017</results_first_submitted>
  <results_first_submitted_qc>June 8, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">July 11, 2017</results_first_posted>
  <last_update_submitted>August 10, 2018</last_update_submitted>
  <last_update_submitted_qc>August 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>plaque psoriasis</keyword>
  <keyword>taclonex</keyword>
  <keyword>crossover</keyword>
  <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>Calcitriol</mesh_term>
    <mesh_term>Betamethasone</mesh_term>
    <mesh_term>Betamethasone Valerate</mesh_term>
    <mesh_term>Betamethasone-17,21-dipropionate</mesh_term>
    <mesh_term>Betamethasone benzoate</mesh_term>
    <mesh_term>Calcipotriene</mesh_term>
    <mesh_term>Betamethasone sodium phosphate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Taclonex Scalp Suspension First, Then Taclonex Ointment</title>
          <description>All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas of psoriasis for three days.&#xD;
Subjects will then cross over to use Taclonex ointment for 3 days. There is no washout between products.</description>
        </group>
        <group group_id="P2">
          <title>Taclonex Ointment First, Then Taclonex Scalp Suspension</title>
          <description>All subjects will use Taclonex Ointment to psoriasis twice daily for 3 days Subjects will then cross over to use Taclonex Scalp Suspension for 3 days.There is no washout between products.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Taclonex Scalp Suspension First, the Taclonex Ointment</title>
          <description>All subjects will use Taclonex Scalp Suspension first to psoriasis twice daily for 3 days Subjects will then cross over to use Taclonex Ointment for 3 days.There is no washout between products.</description>
        </group>
        <group group_id="B2">
          <title>Taclonex Ointment First Then Taclonex Scalp Suspension</title>
          <description>All subjects will use Taclonex Ointment to psoriasis twice daily for 3 days Subjects will then cross over to use Taclonex Scalp Suspension for 3 days.There is no washout between products.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.5" lower_limit="29" upper_limit="64"/>
                    <measurement group_id="B2" value="47" lower_limit="33" upper_limit="63"/>
                    <measurement group_id="B3" value="48" lower_limit="29" upper_limit="64"/>
                  </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="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="13"/>
                  </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 group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Subjective Subject Preference Survey for the First Treatment Session</title>
        <description>Subjective Subject Preference Survey The Subjective Subject Preference Survey consist of 15 questions relating to patients preference of study drug. The survey includes questions such as how the medication feels to touch, how greasy it is, and time it takes to apply. The final question asks patients to rate the overall appeal of the vehicle. Questions are scored on a 7-point scale, where a score of 1 is extremely unpleasant, 4 is neutral, and a score of 7 is extremely appealing. Total preference score based on the Subjective Subject Preference Survey could range from 15-105.</description>
        <time_frame>3 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Taclonex Scalp Suspension First Then Taclonex Ointment</title>
            <description>All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas of psoriasis for three days.&#xD;
Subjects will then cross over to use Taclonex ointment for 3 days. There is no washout between products.</description>
          </group>
          <group group_id="O2">
            <title>Taclonex Ointment First, Then Taclonex Scalp Suspension</title>
            <description>All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment once daily to affected areas of psoriasis for three days.&#xD;
Subjects will then cross over to use Taclonex Suspension for 3 days. There is no washout between products.</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Subject Preference Survey for the First Treatment Session</title>
          <description>Subjective Subject Preference Survey The Subjective Subject Preference Survey consist of 15 questions relating to patients preference of study drug. The survey includes questions such as how the medication feels to touch, how greasy it is, and time it takes to apply. The final question asks patients to rate the overall appeal of the vehicle. Questions are scored on a 7-point scale, where a score of 1 is extremely unpleasant, 4 is neutral, and a score of 7 is extremely appealing. Total preference score based on the Subjective Subject Preference Survey could range from 15-105.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.1" spread="18.4"/>
                    <measurement group_id="O2" value="77.6" spread="21.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Subjective Subject Preference Survey for the Second Treatment Session</title>
        <description>Subjective Subject Preference Survey The Subjective Subject Preference Survey consist of 15 questions relating to patients preference of study drug. The survey includes questions such as how the medication feels to touch, how greasy it is, and time it takes to apply. The final question asks patients to rate the overall appeal of the vehicle. Questions are scored on a 7-point scale, where a score of 1 is extremely unpleasant, 4 is neutral, and a score of 7 is extremely appealing. Total preference score based on the Subjective Subject Preference Survey could range from 15-105.</description>
        <time_frame>3 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Taclonex Scalp Suspension First Then Taclonex Ointment</title>
            <description>All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas of psoriasis for three days.&#xD;
Subjects will then cross over to use Taclonex ointment for 3 days. There is no washout between products.</description>
          </group>
          <group group_id="O2">
            <title>Taclonex Ointment First, Then Taclonex Scalp Suspension</title>
            <description>All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment once daily to affected areas of psoriasis for three days.&#xD;
Subjects will then cross over to use Taclonex Suspension for 3 days. There is no washout between products.</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Subject Preference Survey for the Second Treatment Session</title>
          <description>Subjective Subject Preference Survey The Subjective Subject Preference Survey consist of 15 questions relating to patients preference of study drug. The survey includes questions such as how the medication feels to touch, how greasy it is, and time it takes to apply. The final question asks patients to rate the overall appeal of the vehicle. Questions are scored on a 7-point scale, where a score of 1 is extremely unpleasant, 4 is neutral, and a score of 7 is extremely appealing. Total preference score based on the Subjective Subject Preference Survey could range from 15-105.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.9" spread="22.8"/>
                    <measurement group_id="O2" value="69.4" spread="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>data collected at each visit over one week</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Taclonex Ointment</title>
          <description>All subjects will use Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment once daily for three days to affected areas In this arm, subject will give a preference rating for Taclonex Ointment</description>
        </group>
        <group group_id="E2">
          <title>Taclonex Scalp Suspension</title>
          <description>All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas for three days.&#xD;
In this arm, subjects will give a preference rating for the Suspension</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Steve Feldman, MD</name_or_title>
      <organization>Wake Forest</organization>
      <phone>336-716-3775</phone>
      <email>sfeldman@wakehalth.edu</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/NCT01707043
org study id: IRB00021361
nct id: NCT01707043
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is an open label, investigator-blinded, cross over, prospective, single center study of
      subjects with plaque psoriasis. Taclonex® (calcipotriene 0.005% and betamethasone
      dipropionate 0.064%) Ointment and Taclonex Scalp® (calcipotriene 0.005% and betamethasone
      dipropionate 0.064%) Topical Suspension will each be applied topically once daily.

      The primary objective is to assess the patient preference for Taclonex® (calcipotriene 0.005%
      and betamethasone dipropionate 0.064%) Ointment compared to Taclonex Scalp® (calcipotriene
      0.005% and betamethasone dipropionate 0.064%) Topical Suspension in the treatment of plaque
      psoriasis.
-  Following satisfaction of entry criteria, all subjects at the Baseline/Screening visit
           will be randomized 1:1 to receive either Taclonex® (calcipotriene 0.005% and
           betamethasone dipropionate 0.064%) Ointment or Taclonex Scalp® (calcipotriene 0.005% and
           betamethasone dipropionate 0.064%) Topical Suspension to use once daily for three days
           to affected areas of the body, excluding face and intertriginous areas. Subjects will be
           aware of which product they are using. Investigators will remain blinded.

        -  Subjects will be randomized to use either the ointment or the scalp suspension for the
           first three day treatment period, then cross over to use the other product for second
           three day treatment period.

        -  Each medication will be used within its FDA-approved label for the treatment of plaque
           psoriasis in subjects aged 18 and older. Subjects may not treat areas of the face,
           axilla or groin in this study.

        -  At the Day 3 and Day 6 visits the subjects will complete a questionnaire about their
           psoriasis treatment preferences.

        -  Pregnancy tests will be done on females of childbearing potential at Baseline/Screening.

        -  Adverse events will be monitored at each visit.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Single (Investigator)
measure: Subjective Subject Preference Survey for the First Treatment Session
time frame: 3 days
description: Subjective Subject Preference Survey The Subjective Subject Preference Survey consist of 15 questions relating to patients preference of study drug. The survey includes questions such as how the medication feels to touch, how greasy it is, and time it takes to apply. The final question asks patients to rate the overall appeal of the vehicle. Questions are scored on a 7-point scale, where a score of 1 is extremely unpleasant, 4 is neutral, and a score of 7 is extremely appealing. Total preference score based on the Subjective Subject Preference Survey could range from 15-105.
measure: Subjective Subject Preference Survey for the Second Treatment Session
time frame: 3 days
description: Subjective Subject Preference Survey The Subjective Subject Preference Survey consist of 15 questions relating to patients preference of study drug. The survey includes questions such as how the medication feels to touch, how greasy it is, and time it takes to apply. The final question asks patients to rate the overall appeal of the vehicle. Questions are scored on a 7-point scale, where a score of 1 is extremely unpleasant, 4 is neutral, and a score of 7 is extremely appealing. Total preference score based on the Subjective Subject Preference Survey could range from 15-105.
arm group label: Taclonex Ointment First
arm group type: Active Comparator
description: All subjects will use Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment once daily for three days to affected areas, then switch to Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas for three days
arm group label: Taclonex Scalp Suspension first
arm group type: Active Comparator
description: All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas for three days, then switch to Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment once daily for three days to affected areas,
intervention type: Drug
intervention name: Taclonex
description: Subjects will be evaluated at baseline, Day 3 and Day 6 (or end of study).
arm group label: Taclonex Ointment First
arm group label: Taclonex Scalp Suspension first
other name: Taclonex® Ointment
other name: (calcipotriene 0.005% betamethasone dipropionate 0.064%)
other name: Taclonex Scalp®
other name: (calcipotriene 0.005% and betamethasone dipropionate 0.064%)
other name: Topical Suspension
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Steve R Feldman, M.D, Ph.D.
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
last name: Alan B Fleischer, Jr, M.D.
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
last name: Adele R Clark, PA-C
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Calcitriol
mesh term: Betamethasone
mesh term: Betamethasone Valerate
mesh term: Betamethasone-17,21-dipropionate
mesh term: Betamethasone benzoate
mesh term: Calcipotriene
mesh term: Betamethasone sodium phosphate
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 