<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/NCT03290027</url>
  </required_header>
  <id_info>
    <org_study_id>DFD-03-CD-005</org_study_id>
    <nct_id>NCT03290027</nct_id>
  </id_info>
  <brief_title>A Study of the Safety and Efficacy of DFD-03 for the Treatment of Acne Vulgaris</brief_title>
  <acronym>DFD-03</acronym>
  <official_title>A Multicenter, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Study of the Safety and Efficacy of DFD-03 Lotion in the Treatment of Acne Vulgaris for 12 Weeks</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Reddy's Laboratories Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dr. Reddy's Laboratories Limited</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Enrollment of subjects with mild to moderate facial acne. Efficacy was assessed by using an&#xD;
      Investigator's Global Assessment scale (IGA 5 point scale) and by counting the number of&#xD;
      inflammatory and non-inflammatory lesions on the face at Baseline and Weeks 4, 8, and 12.&#xD;
&#xD;
      Safety assessments included the investigator's assessment of local cutaneous tolerance of the&#xD;
      treated skin (dryness, non-lesional erythema, peeling, stinging, burning, and itching, vital&#xD;
      signs, and adverse events (AEs).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Enrollment of subjects with mild to moderate facial acne. Subjects with acne lesions of any&#xD;
      severity on the chest and/or back (including shoulders) were enrolled provided they had mild&#xD;
      to moderate acne on the face. During the 12-week treatment period subjects used the study&#xD;
      product twice daily. Subjects were instructed to treat the entire face (and chest and/or back&#xD;
      including shoulders, if applicable).&#xD;
&#xD;
      Efficacy was assessed by using an Investigator's Global Assessment scale (IGA 5 point scale)&#xD;
      and by counting the number of inflammatory and non-inflammatory lesions on the face at&#xD;
      Baseline and Weeks 4, 8, and 12.&#xD;
&#xD;
      Safety assessments included the investigator's assessment of local cutaneous tolerance of the&#xD;
      treated skin (dryness, non-lesional erythema, peeling, stinging, burning, and itching;&#xD;
      assessed separately on the chest and/or back including shoulders (if applicable), vital signs&#xD;
      (blood pressure and pulse rate), and adverse events (AEs). Urine pregnancy tests were&#xD;
      performed at Baseline and at every visit through Week 12 for all female subjects. A physical&#xD;
      examination was performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2017</start_date>
  <completion_date type="Actual">April 19, 2018</completion_date>
  <primary_completion_date type="Actual">April 19, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absolute Change in the Inflammatory Lesion Counts on the Face</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Change in inflammatory lesion counts on the face from baseline to Week 12 - will be analyzed using a two way analysis of covariance (ANCOVA) model</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute Change in the Non-inflammatory Lesion Counts on the Face</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Change in non-inflammatory lesion counts on the face from baseline to Week 12 - will be analyzed using the same ANCOVA model</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of Subjects With Treatment Success Based on IGA Score</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>IGA success at Week 12 (an IGA score of 0 (Clear) or 1 (almost clear) with at least a 2-grade reduction from baseline) - will be analyzed using the Cochran-Mantel-Haenszel (CMH) test for general association</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">550</enrollment>
  <condition>Acne Vulgaris</condition>
  <arm_group>
    <arm_group_label>Active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DFD-03 (0.1% tazarotene) Lotion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Vehicle (0% tazarotene) Lotion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DFD-03</intervention_name>
    <description>DFD-03 Lotion</description>
    <arm_group_label>Active</arm_group_label>
    <other_name>Tazarotene 0.1% Lotion</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo Comparator</intervention_name>
    <description>Vehicle (tazarotene 0%) Lotion</description>
    <arm_group_label>Vehicle</arm_group_label>
    <other_name>Vehicle</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Main Inclusion Criteria:&#xD;
&#xD;
          1. Subject must be at least 9 years of age.&#xD;
&#xD;
          2. A clinical diagnosis of mild to moderate facial acne vulgaris.&#xD;
&#xD;
          3. Inflammatory lesion count (papules and pustules) of at least 20 on the face,&#xD;
             Non-inflammatory lesion count (closed and open comedones) of at least 25 on the face&#xD;
             and No more than 2 nodulocystic lesions on the face.&#xD;
&#xD;
          4. Females, regardless of childbearing potential, if sexually active, must be on or use&#xD;
             an acceptable method of birth control.&#xD;
&#xD;
          5. Subject must be in good general health as determined by the investigator and supported&#xD;
             by medical history, physical and Vital Signs exam.&#xD;
&#xD;
        Main Exclusion Criteria:&#xD;
&#xD;
          1. Females who are pregnant or lactating or planning to become pregnant.&#xD;
&#xD;
          2. Treatment with the following products:&#xD;
&#xD;
               1. Topical acne treatments or other topical facial medication on the treatment area.&#xD;
&#xD;
               2. Systemic corticosteroids, systemic acne treatments including systemic antibiotics&#xD;
                  used for treatment of acne.&#xD;
&#xD;
               3. Systemic retinoid use.&#xD;
&#xD;
               4. Undertaken certain facial procedures such as chemical peel, laser treatment,&#xD;
                  photodynamic therapy, acne surgery, cryodestruction or chemodestruction, x-ray&#xD;
                  therapy, intralesional steroids, dermabrasion, or depilation (except eyebrow&#xD;
                  shaping).&#xD;
&#xD;
               5. Treatment with a medication or procedure that, in the opinion of the&#xD;
                  investigator, would put the subject at unacceptable risk for participation in the&#xD;
                  study or may interfere with evaluations in the study.&#xD;
&#xD;
               6. Treatment with an investigational product or device in the 30 days.&#xD;
&#xD;
          3. Known allergic reaction to retinoids or tazarotene.&#xD;
&#xD;
          4. Presence of any facial skin disease or condition that would interfere with the study&#xD;
             or place the subject at unacceptable risk including sunburn, rosacea, seborrheic&#xD;
             dermatitis, perioral dermatitis, lupus, dermatomyositis, psoriasis, eczema, squamous&#xD;
             cell carcinoma, acneiform eruptions caused by medications, steroid acne, steroid&#xD;
             folliculitis, bacterial folliculitis or any other facial disease or condition.&#xD;
&#xD;
          5. Subjects with a serious and/or chronic medical condition such as chronic or active&#xD;
             liver disease, renal impairment, heart disease, severe respiratory disease, rheumatoid&#xD;
             arthritis, current malignancies, immunocompromised conditions, or any other disease&#xD;
             that, in the opinion of the investigator, would interfere with the study or place the&#xD;
             subject at unacceptable risk.&#xD;
&#xD;
          6. Subjects who have been in another investigational trial within 30 days.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Srinivas Sidgiddi, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Dr. Reddy's Laboratories Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dr. Seemal</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <results_first_submitted>May 8, 2020</results_first_submitted>
  <results_first_submitted_qc>May 8, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">May 26, 2020</results_first_posted>
  <disposition_first_submitted>September 24, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>September 24, 2019</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">October 8, 2019</disposition_first_posted>
  <last_update_submitted>February 4, 2021</last_update_submitted>
  <last_update_submitted_qc>February 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acne Vulgaris</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tazarotene</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 2, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT03290027/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Active</title>
          <description>DFD-03 (0.1% tazarotene) Lotion&#xD;
DFD-03: DFD-03 Lotion</description>
        </group>
        <group group_id="P2">
          <title>Vehicle</title>
          <description>Vehicle (0% tazarotene) Lotion&#xD;
Placebo Comparator: Vehicle (tazarotene 0%) Lotion</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="277"/>
                <participants group_id="P2" count="273"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="219"/>
                <participants group_id="P2" count="228"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent to Treat (ITT) - The ITT population was the primary efficacy analysis data set and consisted of all subjects who were randomized and dispensed study medication.</population>
      <group_list>
        <group group_id="B1">
          <title>Active</title>
          <description>DFD-03 (0.1% tazarotene) Lotion&#xD;
DFD-03: DFD-03 Lotion</description>
        </group>
        <group group_id="B2">
          <title>Vehicle</title>
          <description>Vehicle (0% tazarotene) Lotion&#xD;
Placebo Comparator: Vehicle (tazarotene 0%) Lotion</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="277"/>
            <count group_id="B2" value="273"/>
            <count group_id="B3" value="550"/>
          </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="91"/>
                    <measurement group_id="B2" value="91"/>
                    <measurement group_id="B3" value="182"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="186"/>
                    <measurement group_id="B2" value="182"/>
                    <measurement group_id="B3" value="368"/>
                  </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>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.2" spread="7.9"/>
                    <measurement group_id="B2" value="21.1" spread="8.0"/>
                    <measurement group_id="B3" value="21.2" spread="7.9"/>
                  </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="145"/>
                    <measurement group_id="B2" value="158"/>
                    <measurement group_id="B3" value="303"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="132"/>
                    <measurement group_id="B2" value="115"/>
                    <measurement group_id="B3" value="247"/>
                  </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="109"/>
                    <measurement group_id="B2" value="105"/>
                    <measurement group_id="B3" value="214"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="168"/>
                    <measurement group_id="B2" value="168"/>
                    <measurement group_id="B3" value="336"/>
                  </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="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="21"/>
                  </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="51"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="109"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="200"/>
                    <measurement group_id="B2" value="194"/>
                    <measurement group_id="B3" value="394"/>
                  </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="12"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="277"/>
                    <measurement group_id="B2" value="273"/>
                    <measurement group_id="B3" value="550"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change in the Inflammatory Lesion Counts on the Face</title>
        <description>Change in inflammatory lesion counts on the face from baseline to Week 12 - will be analyzed using a two way analysis of covariance (ANCOVA) model</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>Intent To Treat (ITT) Population - All subjects randomized and dispensed study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Active</title>
            <description>DFD-03 (0.1% tazarotene) Lotion&#xD;
DFD-03: DFD-03 Lotion</description>
          </group>
          <group group_id="O2">
            <title>Vehicle</title>
            <description>Vehicle (0% tazarotene) Lotion&#xD;
Placebo Comparator: Vehicle (tazarotene 0%) Lotion</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in the Inflammatory Lesion Counts on the Face</title>
          <description>Change in inflammatory lesion counts on the face from baseline to Week 12 - will be analyzed using a two way analysis of covariance (ANCOVA) model</description>
          <population>Intent To Treat (ITT) Population - All subjects randomized and dispensed study medication.</population>
          <units>Lesions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Lesions</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="277"/>
                <count group_id="O2" value="273"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="277"/>
                <count group_id="O2" value="273"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.1" spread="9.81"/>
                    <measurement group_id="O2" value="29.8" spread="9.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.4" spread="11.43"/>
                    <measurement group_id="O2" value="16.9" spread="11.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change in the Non-inflammatory Lesion Counts on the Face</title>
        <description>Change in non-inflammatory lesion counts on the face from baseline to Week 12 - will be analyzed using the same ANCOVA model</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Active</title>
            <description>DFD-03 (0.1% tazarotene) Lotion&#xD;
DFD-03: DFD-03 Lotion</description>
          </group>
          <group group_id="O2">
            <title>Vehicle</title>
            <description>Vehicle (0% tazarotene) Lotion&#xD;
Placebo Comparator: Vehicle (tazarotene 0%) Lotion</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in the Non-inflammatory Lesion Counts on the Face</title>
          <description>Change in non-inflammatory lesion counts on the face from baseline to Week 12 - will be analyzed using the same ANCOVA model</description>
          <population>ITT Population</population>
          <units>Lesions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="277"/>
                <count group_id="O2" value="273"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.4" spread="14.71"/>
                    <measurement group_id="O2" value="36.6" spread="13.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.3" spread="13.88"/>
                    <measurement group_id="O2" value="22.1" spread="18.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Subjects With Treatment Success Based on IGA Score</title>
        <description>IGA success at Week 12 (an IGA score of 0 (Clear) or 1 (almost clear) with at least a 2-grade reduction from baseline) - will be analyzed using the Cochran-Mantel-Haenszel (CMH) test for general association</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Active</title>
            <description>DFD-03 (0.1% tazarotene) Lotion&#xD;
DFD-03: DFD-03 Lotion</description>
          </group>
          <group group_id="O2">
            <title>Vehicle</title>
            <description>Vehicle (0% tazarotene) Lotion&#xD;
Placebo Comparator: Vehicle (tazarotene 0%) Lotion</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With Treatment Success Based on IGA Score</title>
          <description>IGA success at Week 12 (an IGA score of 0 (Clear) or 1 (almost clear) with at least a 2-grade reduction from baseline) - will be analyzed using the Cochran-Mantel-Haenszel (CMH) test for general association</description>
          <population>ITT Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="277"/>
                <count group_id="O2" value="273"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected from the time treatment was initiated until study product treatment was discontinued, except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Active</title>
          <description>DFD-03 (0.1% tazarotene) Lotion&#xD;
DFD-03: DFD-03 Lotion</description>
        </group>
        <group group_id="E2">
          <title>Vehicle</title>
          <description>Vehicle (0% tazarotene) Lotion&#xD;
Placebo Comparator: Vehicle (tazarotene 0%) Lotion</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedRA 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="277"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="273"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="277"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="273"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Polyps/Epithelioid</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="277"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="273"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <description>Worsening of Anxiety</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="277"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="273"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Overian cyst ruptured</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="277"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="273"/>
              </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="277"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="273"/>
              </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>Srinivas Sidgiddi</name_or_title>
      <organization>Dr. Reddys Laboratories Inc.</organization>
      <phone>9084585362</phone>
      <email>srinivassidgiddi@drreddys.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03290027
org study id: DFD-03-CD-005
nct id: NCT03290027
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
Enrollment of subjects with mild to moderate facial acne. Efficacy was assessed by using an
      Investigator's Global Assessment scale (IGA 5 point scale) and by counting the number of
      inflammatory and non-inflammatory lesions on the face at Baseline and Weeks 4, 8, and 12.

      Safety assessments included the investigator's assessment of local cutaneous tolerance of the
      treated skin (dryness, non-lesional erythema, peeling, stinging, burning, and itching, vital
      signs, and adverse events (AEs).
Enrollment of subjects with mild to moderate facial acne. Subjects with acne lesions of any
      severity on the chest and/or back (including shoulders) were enrolled provided they had mild
      to moderate acne on the face. During the 12-week treatment period subjects used the study
      product twice daily. Subjects were instructed to treat the entire face (and chest and/or back
      including shoulders, if applicable).

      Efficacy was assessed by using an Investigator's Global Assessment scale (IGA 5 point scale)
      and by counting the number of inflammatory and non-inflammatory lesions on the face at
      Baseline and Weeks 4, 8, and 12.

      Safety assessments included the investigator's assessment of local cutaneous tolerance of the
      treated skin (dryness, non-lesional erythema, peeling, stinging, burning, and itching;
      assessed separately on the chest and/or back including shoulders (if applicable), vital signs
      (blood pressure and pulse rate), and adverse events (AEs). Urine pregnancy tests were
      performed at Baseline and at every visit through Week 12 for all female subjects. A physical
      examination was performed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Absolute Change in the Inflammatory Lesion Counts on the Face
time frame: Baseline to Week 12
description: Change in inflammatory lesion counts on the face from baseline to Week 12 - will be analyzed using a two way analysis of covariance (ANCOVA) model
measure: Absolute Change in the Non-inflammatory Lesion Counts on the Face
time frame: Baseline to Week 12
description: Change in non-inflammatory lesion counts on the face from baseline to Week 12 - will be analyzed using the same ANCOVA model
measure: Proportion of Subjects With Treatment Success Based on IGA Score
time frame: Baseline to Week 12
description: IGA success at Week 12 (an IGA score of 0 (Clear) or 1 (almost clear) with at least a 2-grade reduction from baseline) - will be analyzed using the Cochran-Mantel-Haenszel (CMH) test for general association
arm group label: Active
arm group type: Experimental
description: DFD-03 (0.1% tazarotene) Lotion
arm group label: Vehicle
arm group type: Placebo Comparator
description: Vehicle (0% tazarotene) Lotion
intervention type: Drug
intervention name: DFD-03
description: DFD-03 Lotion
arm group label: Active
other name: Tazarotene 0.1% Lotion
intervention type: Other
intervention name: Placebo Comparator
description: Vehicle (tazarotene 0%) Lotion
arm group label: Vehicle
other name: Vehicle
criteria: 
gender: All
minimum age: 9 Years
maximum age: N/A
healthy volunteers: No
last name: Srinivas Sidgiddi, M.D.
role: Study Director
affiliation: Dr. Reddy's Laboratories Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acne Vulgaris
mesh term: Tazarotene
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 