<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/NCT02191007</url>
  </required_header>
  <id_info>
    <org_study_id>CUP2012D001</org_study_id>
    <nct_id>NCT02191007</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of Calcipotriol Betamethasone Plus Calcipotriol in Sequential Therapy to Psoriasis</brief_title>
  <official_title>Multi-center,Single Blind, Parallel-Controlled Study of the Efficacy and Safety of Calcipotriol Betamethasone Ointment Plus Calcipotriol Ointment in Sequential Therapy to Psoriasis Vulgaris</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xijing Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xijing Hospital</source>
  <brief_summary>
    <textblock>
      Evaluate the efficacy and safety of Calcipotriol Betamethasone Ointment and Calcipotriol&#xD;
      Ointment in sequential therapy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1.240 subjects will be randomized 1:1:1 divided into the 3 groups 2.Week0 to Week4,each group&#xD;
      were treated with Calcipotriol Betamethasone Ointment 3.Week4 to Week12, the there group were&#xD;
      respectively treated with Calcipotriol Betamethasone Ointment,Calcipotriol Ointment and Urea&#xD;
      Cream 4.The efficacy and safety were evaluated at the baseline, as well as 1, 4, 8 and 12&#xD;
      weeks after the beginning of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2013</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>N/A</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Psoriasis Area and Severity Index 50 ,75 and 90</measure>
    <time_frame>week0 and week12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to recurrence</measure>
    <time_frame>Any Point In Time after 4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">230</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Calcipotriol/Betamethasone and Calcipotriol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Calcipotriol/Betamethasone ointment 1/d for 4 weeks; Calcipotriol ointment bid for 6 weeks on-demand treatment period;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Calcipotriol/Betamethasone and urea cream</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>alcipotriol/Betamethasone ointment 1/d for 4 weeks , urea cream 1/d for 6 weeks on-demand treatment period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Calcipotriol/Betamethasone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Calcipotriol/Betamethasone ointment 1/d for 4 weeks, Calcipotriol/Betamethasone ointment 1/d for 6 weeks on-demand treatment period</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Calcipotriol Betamethasone ointment and Calcipotriol ointment</intervention_name>
    <arm_group_label>Calcipotriol/Betamethasone and Calcipotriol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Calcipotriol Betamethasone ointment</intervention_name>
    <arm_group_label>Calcipotriol/Betamethasone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Calcipotriol Betamethasone ointment and Urea Cream</intervention_name>
    <arm_group_label>Calcipotriol/Betamethasone and urea cream</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects who signed Informed Consent Form；&#xD;
&#xD;
          2. Male or female subjects 18-65 years of age；&#xD;
&#xD;
          3. Clinically confirmed diagnosis of plaque psoriasis as per the diagnostic criteria for&#xD;
             psoriasis vulgaris specified in Clinical Dermatology.&#xD;
&#xD;
          4. Involved area 1-10% of the body surface area.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Incompliance with the diagnosis of plaque psoriasis or plaque area &gt; 10% of the body&#xD;
             surface area.&#xD;
&#xD;
          2. Erythrodermic psoriasis, psoriasis arfhropathica or pustular psoriasis;&#xD;
&#xD;
          3. Known allergy to any component of the test or control drug；&#xD;
&#xD;
          4. Concomitant allergic skin disease such as eczema， contact dermatitis and urticaria, or&#xD;
             other serious and/or extensive skin disease；&#xD;
&#xD;
          5. Systemic medication or ultraviolet therapy for psoriasis within 4 weeks prior to study&#xD;
             initiation；&#xD;
&#xD;
          6. Topical use of external drug for psoriasis within 2 weeks prior to study initiation；&#xD;
&#xD;
          7. Women of child-bearing potential who are pregnant, plan to become pregnant during&#xD;
             study or are lactating；&#xD;
&#xD;
          8. Glucocorticoid or immunodepressant, or hypoleukemia due to tumor or chemotherapy&#xD;
             within the last 4 weeks；&#xD;
&#xD;
          9. Serious life-threatening condition that allows a life expectancy of less than 2&#xD;
             months；&#xD;
&#xD;
         10. Inability to guarantee taking medications and completing visits as scheduled during&#xD;
             the study;&#xD;
&#xD;
         11. Serious infection that is not suitable for external treatment；&#xD;
&#xD;
         12. Any other condition that the investigator deems unsuitable for entering the study.&#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>
      <name>Xijing Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>December 26, 2013</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>July 11, 2014</last_update_submitted>
  <last_update_submitted_qc>July 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xijing Hospital</investigator_affiliation>
    <investigator_full_name>xjpfW</investigator_full_name>
    <investigator_title>Wang Gang</investigator_title>
  </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>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>
  <!-- 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/NCT02191007
org study id: CUP2012D001
nct id: NCT02191007
lead sponsor: 
Evaluate the efficacy and safety of Calcipotriol Betamethasone Ointment and Calcipotriol
      Ointment in sequential therapy
1.240 subjects will be randomized 1:1:1 divided into the 3 groups 2.Week0 to Week4,each group
      were treated with Calcipotriol Betamethasone Ointment 3.Week4 to Week12, the there group were
      respectively treated with Calcipotriol Betamethasone Ointment,Calcipotriol Ointment and Urea
      Cream 4.The efficacy and safety were evaluated at the baseline, as well as 1, 4, 8 and 12
      weeks after the beginning of treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Psoriasis Area and Severity Index 50 ,75 and 90
time frame: week0 and week12
measure: Time to recurrence
time frame: Any Point In Time after 4 weeks
arm group label: Calcipotriol/Betamethasone and Calcipotriol
arm group type: Experimental
description: Calcipotriol/Betamethasone ointment 1/d for 4 weeks; Calcipotriol ointment bid for 6 weeks on-demand treatment period;
arm group label: Calcipotriol/Betamethasone and urea cream
arm group type: Sham Comparator
description: alcipotriol/Betamethasone ointment 1/d for 4 weeks , urea cream 1/d for 6 weeks on-demand treatment period
arm group label: Calcipotriol/Betamethasone
arm group type: Active Comparator
description: Calcipotriol/Betamethasone ointment 1/d for 4 weeks, Calcipotriol/Betamethasone ointment 1/d for 6 weeks on-demand treatment period
intervention type: Drug
intervention name: Calcipotriol Betamethasone ointment and Calcipotriol ointment
arm group label: Calcipotriol/Betamethasone and Calcipotriol
intervention type: Drug
intervention name: Calcipotriol Betamethasone ointment
arm group label: Calcipotriol/Betamethasone
intervention type: Drug
intervention name: Calcipotriol Betamethasone ointment and Urea Cream
arm group label: Calcipotriol/Betamethasone and urea cream
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Xijing Hospital
investigator full name: xjpfW
investigator title: Wang Gang
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