<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/NCT01694433</url>
  </required_header>
  <id_info>
    <org_study_id>1R01AR053542-01A2</org_study_id>
    <secondary_id>1R01AR053542-01A2</secondary_id>
    <nct_id>NCT01694433</nct_id>
  </id_info>
  <brief_title>&quot;Clinical Trial to Determine the Efficacy of Vitamin D for Acne Therapy&quot;</brief_title>
  <official_title>Innate Immunity in Acne Vulgaris</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to study the effects of topical Vitamin D cream (Calcipotriene,&#xD;
      also known as Dovonex) on acne. The information gained from this study may lead to new&#xD;
      treatments for acne. In this study, Calcipotriene will be compared with a placebo, a cream&#xD;
      that looks like Calcipotriene, but contains no active ingredients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a randomized, double-blinded, parallel group comparison of calcipotriene&#xD;
      vs. placebo cream. Patients with acne will use calcipotriene or placebo cream 2x/day for 12&#xD;
      weeks and will be assessed at weeks 0, 2, 4, 8 and 12. Each group will have 24 subjects as&#xD;
      calculated by power analysis. Three additional subjects for each group will be recruited for&#xD;
      possible dropouts and total of 27 subjects will be recruited for each group. Primary endpoint&#xD;
      (lesion count) and secondary endpoint (IGA- Investigator's Global Assessment) will be&#xD;
      determined. Lesion counts will be assessed by one of the investigator physicians or nurse&#xD;
      practitioner. Adverse effects including irritation, dry skin, inflammation and worsening of&#xD;
      the lesions will be noted at each visit. Photographs will be taken to aid in assessing the&#xD;
      clinical changes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">January 9, 2014</completion_date>
  <primary_completion_date type="Actual">January 9, 2014</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lesion Counts (Total, Inflammatory and Non-inflammatory)</measure>
    <time_frame>Weeks 2, 4, 8 &amp; 12</time_frame>
    <description>Lesion counts will be assessed by one of the investigator physicians or nurse practitioner.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acne Severity as Assessed With the Investigator's Global Assessment (IGA)</measure>
    <time_frame>Weeks 2, 4, 8 &amp; 12</time_frame>
    <description>Investigator's Global Assessment (IGA) is a 5-point scale of acne severity, ranging from 0 (Clear) to 4 (Severe)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Acne Vulgaris</condition>
  <arm_group>
    <arm_group_label>Calcipotriene Cream</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Calcipotriene Cream will be supplied as 1g daily use individual tubes to be used 2x/day (once in the morning and once in the evening) for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The Placebo Cream will be supplied as 1g daily use individual tubes to be used 2x/day (once in the morning and once in the evening) for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Calcipotriene</intervention_name>
    <description>1g daily BID</description>
    <arm_group_label>Calcipotriene Cream</arm_group_label>
    <other_name>Dovonex</other_name>
    <other_name>Vitamin D cream</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>1g daily BID</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo cream manufactured to mimic calcipotriene</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 years or older, of either gender and any racial/ethnic group&#xD;
&#xD;
          2. Subjects must have clinically evident mild to moderate acne vulgaris of the facial&#xD;
             area, IGA scale, grade 2-4&#xD;
&#xD;
          3. Subjects must understand and sign the informed consent prior to participation&#xD;
&#xD;
          4. Subjects must be in generally good health&#xD;
&#xD;
          5. Subjects must be able and willing to comply with the requirements of the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Oral retinoid use within twelve months of entry into the study&#xD;
&#xD;
          2. Systemic acne therapies (oral antibiotics) within 30 days of entry into the study&#xD;
&#xD;
          3. Topical acne therapies (retinoids, antibiotics) within 14 days of entry into the study&#xD;
&#xD;
          4. Non-compliant patients&#xD;
&#xD;
          5. Pregnant or nursing women&#xD;
&#xD;
          6. Subjects with a significant medical history or concurrent condition that the&#xD;
             investigator(s) feel is not safe for study participation&#xD;
&#xD;
          7. Subjects with hypercalcemia (hyperparathyroidism, kidney disease)&#xD;
&#xD;
          8. Subjects who cannot avoid excessive exposure to either natural or artificial sunlight.&#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>Jenny Kim, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCLA Department of Medicine/Division of Dermatology and Nutrition</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA Dermatology</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <results_first_submitted>March 15, 2019</results_first_submitted>
  <results_first_submitted_qc>April 18, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">May 7, 2019</results_first_posted>
  <last_update_submitted>April 18, 2019</last_update_submitted>
  <last_update_submitted_qc>April 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Jenny Kim, MD, PhD</investigator_full_name>
    <investigator_title>Professor of Medicine/Dermatology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acne Vulgaris</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Calcitriol</mesh_term>
    <mesh_term>Calcipotriene</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Calcipotriene Cream</title>
          <description>The Calcipotriene Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks.&#xD;
Calcipotriene: 1g daily BID</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>The Placebo Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks.&#xD;
Placebo: 1g daily BID</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Baseline Visit</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>One enrolled participant withdrew from the Placebo arm prior to Baseline</population>
      <group_list>
        <group group_id="B1">
          <title>Calcipotriene Cream</title>
          <description>The Calcipotriene Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks.&#xD;
Calcipotriene: 1g daily BID</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>The Placebo Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks.&#xD;
Placebo: 1g daily BID</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="33"/>
            <count group_id="B2" value="32"/>
            <count group_id="B3" value="65"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</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>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="22"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="21"/>
                  </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="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="51"/>
                  </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="13"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="28"/>
                  </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="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>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="33"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Inflammatory Lesion Count</title>
          <units>Lesions</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.8" lower_limit="0" upper_limit="59"/>
                    <measurement group_id="B2" value="11.7" lower_limit="1" upper_limit="34"/>
                    <measurement group_id="B3" value="14.3" lower_limit="1" upper_limit="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Non-inflammatory Lesion Count</title>
          <units>Lesions</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.4" lower_limit="4" upper_limit="440"/>
                    <measurement group_id="B2" value="38.4" lower_limit="2" upper_limit="141"/>
                    <measurement group_id="B3" value="43.5" lower_limit="4" upper_limit="440"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total Lesion Count</title>
          <units>Lesions</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.3" lower_limit="13" upper_limit="452"/>
                    <measurement group_id="B2" value="50.1" lower_limit="5" upper_limit="146"/>
                    <measurement group_id="B3" value="57.8" lower_limit="5" upper_limit="452"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>IGA at Baseline</title>
          <description>Investigator's Global Assessment (IGA) is a 5-point scale of acne severity, ranging from 0 (Clear) to 4 (Severe)</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.15" lower_limit="2" upper_limit="4"/>
                    <measurement group_id="B2" value="3.06" lower_limit="1" upper_limit="4"/>
                    <measurement group_id="B3" value="3.11" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Lesion Counts (Total, Inflammatory and Non-inflammatory)</title>
        <description>Lesion counts will be assessed by one of the investigator physicians or nurse practitioner.</description>
        <time_frame>Weeks 2, 4, 8 &amp; 12</time_frame>
        <population>The number of participants analyzed differ from overall number analyzed due to participant withdrawal or missed study visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Calcipotriene Cream</title>
            <description>The Calcipotriene Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks.&#xD;
Calcipotriene: 1g daily BID</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>The Placebo Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks.&#xD;
Placebo: 1g daily BID</description>
          </group>
        </group_list>
        <measure>
          <title>Lesion Counts (Total, Inflammatory and Non-inflammatory)</title>
          <description>Lesion counts will be assessed by one of the investigator physicians or nurse practitioner.</description>
          <population>The number of participants analyzed differ from overall number analyzed due to participant withdrawal or missed study visit.</population>
          <units>Lesions</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Inflammatory lesions at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.4" lower_limit="1" upper_limit="89"/>
                    <measurement group_id="O2" value="13.4" lower_limit="0" upper_limit="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inflammatory lesions at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.8" lower_limit="0" upper_limit="66"/>
                    <measurement group_id="O2" value="9.9" lower_limit="1" upper_limit="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inflammatory lesions at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.1" lower_limit="0" upper_limit="94"/>
                    <measurement group_id="O2" value="10.2" lower_limit="0" upper_limit="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inflammatory lesions at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.5" lower_limit="0" upper_limit="37"/>
                    <measurement group_id="O2" value="7.0" lower_limit="0" upper_limit="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-inflammatory lesions at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.9" lower_limit="1" upper_limit="152"/>
                    <measurement group_id="O2" value="33.1" lower_limit="0" upper_limit="131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-inflammatory lesions at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.5" lower_limit="3" upper_limit="299"/>
                    <measurement group_id="O2" value="34.4" lower_limit="0" upper_limit="198"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-inflammatory lesions at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.1" lower_limit="0" upper_limit="136"/>
                    <measurement group_id="O2" value="24.3" lower_limit="0" upper_limit="110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-inflammatory lesions at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.6" lower_limit="0" upper_limit="78"/>
                    <measurement group_id="O2" value="20.2" lower_limit="1" upper_limit="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total lesions at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.0" lower_limit="6" upper_limit="241"/>
                    <measurement group_id="O2" value="46.5" lower_limit="2" upper_limit="158"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total lesions at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.4" lower_limit="0" upper_limit="299"/>
                    <measurement group_id="O2" value="44.3" lower_limit="2" upper_limit="232"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total lesions at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.2" lower_limit="0" upper_limit="136"/>
                    <measurement group_id="O2" value="34.55" lower_limit="1" upper_limit="134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total lesions at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.1" lower_limit="0" upper_limit="78"/>
                    <measurement group_id="O2" value="27.24" lower_limit="2" upper_limit="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Acne Severity as Assessed With the Investigator's Global Assessment (IGA)</title>
        <description>Investigator's Global Assessment (IGA) is a 5-point scale of acne severity, ranging from 0 (Clear) to 4 (Severe)</description>
        <time_frame>Weeks 2, 4, 8 &amp; 12</time_frame>
        <population>The number of participants analyzed differ from overall number analyzed due to participant withdrawal or missed study visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Calcipotriene Cream</title>
            <description>The Calcipotriene Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks.&#xD;
Calcipotriene: 1g daily BID</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>The Placebo Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks.&#xD;
Placebo: 1g daily BID</description>
          </group>
        </group_list>
        <measure>
          <title>Acne Severity as Assessed With the Investigator's Global Assessment (IGA)</title>
          <description>Investigator's Global Assessment (IGA) is a 5-point scale of acne severity, ranging from 0 (Clear) to 4 (Severe)</description>
          <population>The number of participants analyzed differ from overall number analyzed due to participant withdrawal or missed study visit.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IGA at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.77" lower_limit="1" upper_limit="4"/>
                    <measurement group_id="O2" value="2.9" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IGA at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.83" lower_limit="1" upper_limit="4"/>
                    <measurement group_id="O2" value="2.59" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IGA at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.21" lower_limit="1" upper_limit="4"/>
                    <measurement group_id="O2" value="2.48" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IGA at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.23" lower_limit="1" upper_limit="4"/>
                    <measurement group_id="O2" value="2.31" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Calcipotriene Cream</title>
          <description>The Calcipotriene Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks.&#xD;
Calcipotriene: 1g daily BID</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>The Placebo Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks.&#xD;
Placebo: 1g daily BID</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="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Bump on eyelid</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>GI Flu</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Flu-like symptoms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Sore Throat</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergic reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Common cold/allergy</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="33"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Menstrual cramps</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Bruising</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Bug bite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Facial dryness</sub_title>
                <counts group_id="E1" events="22" subjects_affected="18" subjects_at_risk="33"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hives</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Facial irritation</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Itching</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Redness</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="33"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Jenny Kim</name_or_title>
      <organization>UCLA</organization>
      <phone>310-825-5420</phone>
      <email>jekim@mednet.ucla.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/NCT01694433
org study id: 1R01AR053542-01A2
secondary id: 1R01AR053542-01A2
nct id: NCT01694433
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
The purpose of this study is to study the effects of topical Vitamin D cream (Calcipotriene,
      also known as Dovonex) on acne. The information gained from this study may lead to new
      treatments for acne. In this study, Calcipotriene will be compared with a placebo, a cream
      that looks like Calcipotriene, but contains no active ingredients.
This study will be a randomized, double-blinded, parallel group comparison of calcipotriene
      vs. placebo cream. Patients with acne will use calcipotriene or placebo cream 2x/day for 12
      weeks and will be assessed at weeks 0, 2, 4, 8 and 12. Each group will have 24 subjects as
      calculated by power analysis. Three additional subjects for each group will be recruited for
      possible dropouts and total of 27 subjects will be recruited for each group. Primary endpoint
      (lesion count) and secondary endpoint (IGA- Investigator's Global Assessment) will be
      determined. Lesion counts will be assessed by one of the investigator physicians or nurse
      practitioner. Adverse effects including irritation, dry skin, inflammation and worsening of
      the lesions will be noted at each visit. Photographs will be taken to aid in assessing the
      clinical changes.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Lesion Counts (Total, Inflammatory and Non-inflammatory)
time frame: Weeks 2, 4, 8 & 12
description: Lesion counts will be assessed by one of the investigator physicians or nurse practitioner.
measure: Acne Severity as Assessed With the Investigator's Global Assessment (IGA)
time frame: Weeks 2, 4, 8 & 12
description: Investigator's Global Assessment (IGA) is a 5-point scale of acne severity, ranging from 0 (Clear) to 4 (Severe)
arm group label: Calcipotriene Cream
arm group type: Experimental
description: The Calcipotriene Cream will be supplied as 1g daily use individual tubes to be used 2x/day (once in the morning and once in the evening) for 12 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: The Placebo Cream will be supplied as 1g daily use individual tubes to be used 2x/day (once in the morning and once in the evening) for 12 weeks.
intervention type: Drug
intervention name: Calcipotriene
description: 1g daily BID
arm group label: Calcipotriene Cream
other name: Dovonex
other name: Vitamin D cream
intervention type: Drug
intervention name: Placebo
description: 1g daily BID
arm group label: Placebo
other name: Placebo cream manufactured to mimic calcipotriene
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jenny Kim, MD,PhD
role: Principal Investigator
affiliation: UCLA Department of Medicine/Division of Dermatology and Nutrition
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Jenny Kim, MD, PhD
investigator title: Professor of Medicine/Dermatology
mesh term: Acne Vulgaris
mesh term: Vitamin D
mesh term: Calcitriol
mesh term: Calcipotriene
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 