<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/NCT03292640</url>
  </required_header>
  <id_info>
    <org_study_id>DFD-03-CD-006</org_study_id>
    <nct_id>NCT03292640</nct_id>
  </id_info>
  <brief_title>A Study of the Safety and Efficacy of DFD-03 Lotion in the Treatment of Acne Vulgaris for 12 Weeks</brief_title>
  <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 vulgaris.&#xD;
&#xD;
      Co-Primary efficacy endpoints included:&#xD;
&#xD;
        -  Absolute change from Baseline to Week 12 in the inflammatory lesion counts on the face&#xD;
&#xD;
        -  Absolute change from Baseline to Week 12 in the non-inflammatory lesion counts on the&#xD;
           face&#xD;
&#xD;
        -  Proportion of subjects with a clinical response of &quot;success&quot; at Week 12 for lesions on&#xD;
           the face. Success based on IGA is defined as an IGA score of 0 (Clear) or 1 (Almost&#xD;
           clear) at Week 12 with at least a 2-grade reduction from Baseline.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Enrollment of subjects with mild to moderate facial acne vulgaris. 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 with approximately 12 hours between applications. Subjects were&#xD;
      instructed to treat the entire face (and chest/back including shoulders, if applicable).&#xD;
&#xD;
      Co-Primary efficacy endpoints included:&#xD;
&#xD;
        -  Absolute change from Baseline to Week 12 in the inflammatory lesion counts on the face&#xD;
&#xD;
        -  Absolute change from Baseline to Week 12 in the non-inflammatory lesion counts on the&#xD;
           face&#xD;
&#xD;
        -  Proportion of subjects with a clinical response of &quot;success&quot; at Week 12 for lesions on&#xD;
           the face. Success based on IGA is defined as an IGA score of 0 (Clear) or 1 (Almost&#xD;
           clear) at Week 12 with at least a 2-grade reduction from Baseline.&#xD;
&#xD;
      The primary safety endpoint was treatment-emergent adverse events (TEAEs). Other safety&#xD;
      variables included local cutaneous tolerance evaluation (dryness, non-lesional erythema,&#xD;
      peeling, stinging, burning, and itching) and vital signs (blood pressure and pulse rate).&#xD;
      Urine pregnancy tests were performed at Baseline and at every visit through Week 12 for all&#xD;
      female subjects. A physical examination was performed at the Baseline Visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 6, 2017</start_date>
  <completion_date type="Actual">May 14, 2018</completion_date>
  <primary_completion_date type="Actual">May 14, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of Subjects With a Clinical Response of &quot;Success&quot; at Week 12 for Lesions on the Face Based on IGA.</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)</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 ANCOVA model</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">547</enrollment>
  <condition>Acne Vulgaris</condition>
  <arm_group>
    <arm_group_label>DFD-03 Lotion (0.1% tazarotene)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DFD-03 Lotion (0.1% tazarotene)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DFD-03 Vehicle (0% tazarotene)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>DFD-03 Vehicle Lotion (0% tazarotene)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DFD-03 (0.1% tazarotene) Lotion</intervention_name>
    <description>DFD-03 Lotion (0.1% tazarotene) - twice daily application</description>
    <arm_group_label>DFD-03 Lotion (0.1% tazarotene)</arm_group_label>
    <other_name>DFD-03</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DFD-03 (0% tazarotene) Lotion (Placebo)</intervention_name>
    <description>DFD-03 Vehicle Lotion (0% tazarotene) - twice daily application</description>
    <arm_group_label>DFD-03 Vehicle (0% tazarotene)</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject must be at least 9 years of age.&#xD;
&#xD;
          2. Female subjects must be having their period at the Baseline Visit (as reported by the&#xD;
             subject), except for subjects using hormonal contraceptives that preclude menstrual&#xD;
             periods, if the subject is premenarcheal, is postmenopausal for at least 12 months&#xD;
             prior to baseline, is surgically sterilized (i.e. tubal ligation) or if the subject is&#xD;
             without a uterus and /or both ovaries.&#xD;
&#xD;
          3. A clinical diagnosis of facial mild to moderate acne vulgaris. Subjects with acne&#xD;
             lesions on the chest and/or back (including shoulders) in addition to those on the&#xD;
             face have the option of treating their back and/or chest (including shoulders) in&#xD;
             addition to their face.&#xD;
&#xD;
          4. Inflammatory lesion count (papules and pustules) of at least 20 on the face, and&#xD;
             non-inflammatory lesion count (closed and open comedones) of at least 25 on the face,&#xD;
             including the nose, and no more than 2 nodulocystic lesions on the face, including the&#xD;
             nose.&#xD;
&#xD;
          5. Females, regardless of childbearing potential:&#xD;
&#xD;
             Must have a negative urine pregnancy test and if sexually active, must be on or use an&#xD;
             acceptable method of birth control.&#xD;
&#xD;
          6. Subjects must be willing to comply with sun avoidance measures for the face (as well&#xD;
             as back/chest and shoulders, if applicable) including use of investigator-approved&#xD;
             sunscreen and/or hats, have limited sun exposure time, and have no tanning bed use.&#xD;
&#xD;
          7. Subject must be in good general health as determined by the investigator and supported&#xD;
             by the medical history, physical examination, and normal or not clinically significant&#xD;
             abnormal vital signs (blood pressure and pulse).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Females who are pregnant or lactating or planning to become pregnant during the study&#xD;
             period.&#xD;
&#xD;
          2. Treatment with the following products:&#xD;
&#xD;
               1. Topical acne treatments or other topical facial medication on the treatment area&#xD;
                  in the 14 days prior to the Baseline Visit, including prescription and&#xD;
                  non-prescription products.&#xD;
&#xD;
               2. Systemic corticosteroids, systemic acne treatments including systemic antibiotics&#xD;
                  used for treatment of acne, potential photosensitizing agents spironolactone,&#xD;
                  flutamide, or immunosuppressant drugs in the 30 days prior to the Baseline Visit.&#xD;
&#xD;
               3. Systemic retinoid use in the 180 days prior to the Baseline Visit.&#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) in the 30 days prior to the Baseline Visit. After the subject is&#xD;
                  enrolled in the study, eyebrow shaping (except for tweezing) is prohibited.&#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 prior to the&#xD;
                  Baseline Visit.&#xD;
&#xD;
          3. Known allergic reaction to retinoids or tazarotene or any of the other ingredients of&#xD;
             these products.&#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;
        7. Subjects who have been treated for alcohol dependence or alcohol or drug abuse in the&#xD;
        year.&#xD;
&#xD;
        8. 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 R. Sidgiddi, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Dr. Reddy's Laboratories</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Dermatology Clinical Research Inc.</name>
      <address>
        <city>Fremont</city>
        <state>California</state>
        <zip>94538</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 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <results_first_submitted>May 20, 2020</results_first_submitted>
  <results_first_submitted_qc>May 20, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 9, 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>Nicotinic Acids</mesh_term>
    <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/40/NCT03292640/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>DFD-03 Lotion (0.1% Tazarotene)</title>
          <description>DFD-03 (0.1% tazarotene) Lotion: Subjects will apply a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. Care should be taken to avoid the areas around the eyes, mouth, and nostrils. After a short time, the subject will rinse off the product by thoroughly rinsing with warm water. This procedure will be followed twice daily, in the morning and at bedtime, approximately 12 hours apart.</description>
        </group>
        <group group_id="P2">
          <title>DFD-03 Vehicle (0% Tazarotene)</title>
          <description>DFD-03 (0% tazarotene) Lotion (Placebo): Subjects will apply a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. Care should be taken to avoid the areas around the eyes, mouth, and nostrils. After a short time, the subject will rinse off the product by thoroughly rinsing with warm water. This procedure will be followed twice daily, in the morning and at bedtime, approximately 12 hours apart.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="275"/>
                <participants group_id="P2" count="272"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="214"/>
                <participants group_id="P2" count="230"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
                <participants group_id="P2" count="42"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>DFD-03 Lotion (0.1% Tazarotene)</title>
          <description>DFD-03 (0.1% tazarotene) Lotion: Subjects will apply a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. Care should be taken to avoid the areas around the eyes, mouth, and nostrils. After a short time, the subject will rinse off the product by thoroughly rinsing with warm water. This procedure will be followed twice daily, in the morning and at bedtime, approximately 12 hours apart.</description>
        </group>
        <group group_id="B2">
          <title>DFD-03 Vehicle (0% Tazarotene)</title>
          <description>DFD-03 (0% tazarotene) Lotion (Placebo): Subjects will apply a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. Care should be taken to avoid the areas around the eyes, mouth, and nostrils. After a short time, the subject will rinse off the product by thoroughly rinsing with warm water. This procedure will be followed twice daily, in the morning and at bedtime, approximately 12 hours apart.</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="275"/>
            <count group_id="B2" value="272"/>
            <count group_id="B3" value="547"/>
          </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="93"/>
                    <measurement group_id="B2" value="85"/>
                    <measurement group_id="B3" value="178"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="182"/>
                    <measurement group_id="B2" value="187"/>
                    <measurement group_id="B3" value="369"/>
                  </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="20.7" spread="6.5"/>
                    <measurement group_id="B2" value="21.3" spread="7.6"/>
                    <measurement group_id="B3" value="21.0" spread="7.1"/>
                  </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="143"/>
                    <measurement group_id="B2" value="111"/>
                    <measurement group_id="B3" value="254"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="132"/>
                    <measurement group_id="B2" value="161"/>
                    <measurement group_id="B3" value="293"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="85"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="186"/>
                    <measurement group_id="B2" value="186"/>
                    <measurement group_id="B3" value="372"/>
                  </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="12"/>
                    <measurement group_id="B3" value="24"/>
                  </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="275"/>
                    <measurement group_id="B2" value="272"/>
                    <measurement group_id="B3" value="547"/>
                  </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</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>DFD-03 Lotion (0.1% Tazarotene)</title>
            <description>DFD-03 (0.1% tazarotene) Lotion: Subjects will apply a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. Care should be taken to avoid the areas around the eyes, mouth, and nostrils. After a short time, the subject will rinse off the product by thoroughly rinsing with warm water. This procedure will be followed twice daily, in the morning and at bedtime, approximately 12 hours apart.</description>
          </group>
          <group group_id="O2">
            <title>DFD-03 Vehicle (0% Tazarotene)</title>
            <description>DFD-03 (0% tazarotene) Lotion (Placebo): Subjects will apply a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. Care should be taken to avoid the areas around the eyes, mouth, and nostrils. After a short time, the subject will rinse off the product by thoroughly rinsing with warm water. This procedure will be followed twice daily, in the morning and at bedtime, approximately 12 hours apart.</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</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>Face</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="275"/>
                <count group_id="O2" value="272"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Face</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="275"/>
                <count group_id="O2" value="272"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.4" spread="13.82"/>
                    <measurement group_id="O2" value="29.7" spread="13.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.9" spread="12.14"/>
                    <measurement group_id="O2" value="18.2" spread="16.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Subjects With a Clinical Response of &quot;Success&quot; at Week 12 for Lesions on the Face Based on IGA.</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)</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>DFD-03 Lotion (0.1% Tazarotene)</title>
            <description>DFD-03 (0.1% tazarotene) Lotion: Subjects applied a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. After a short time, the subject rinsed off the product with warm water. This procedure was followed twice daily, in the morning and at bedtime, approximately 12 hours apart.</description>
          </group>
          <group group_id="O2">
            <title>DFD-03 Vehicle (0% Tazarotene)</title>
            <description>DFD-03 (0% tazarotene) Lotion (Placebo): Subjects applied a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. After a short time, the subject rinsed off the product with warm water. This procedure was followed twice daily, in the morning and at bedtime, approximately 12 hours apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With a Clinical Response of &quot;Success&quot; at Week 12 for Lesions on the Face Based on IGA.</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)</description>
          <population>Intent To Treat (ITT) Population - All subjects randomized and dispensed study medication.</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="275"/>
                <count group_id="O2" value="272"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58"/>
                    <measurement group_id="O2" value="26"/>
                  </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 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>DFD-03 Lotion (0.1% Tazarotene)</title>
            <description>DFD-03 Lotion (0.1% tazarotene)&#xD;
DFD-03 (0.1% tazarotene) Lotion: DFD-03 Lotion (0.1% tazarotene) - twice daily application</description>
          </group>
          <group group_id="O2">
            <title>DFD-03 Vehicle (0% Tazarotene)</title>
            <description>DFD-03 Vehicle Lotion (0% tazarotene)&#xD;
DFD-03 (0% tazarotene) Lotion (Placebo): DFD-03 Vehicle Lotion (0% tazarotene) - twice daily application</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 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>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="275"/>
                <count group_id="O2" value="272"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.8" spread="33.93"/>
                    <measurement group_id="O2" value="44.4" spread="27.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.3" spread="18.13"/>
                    <measurement group_id="O2" value="29.7" spread="23.12"/>
                  </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 (i.e. up to 12 weeks), 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>DFD-03 Lotion (0.1% Tazarotene)</title>
          <description>DFD-03 (0.1% tazarotene) Lotion was to be applied twice daily for 12 weeks</description>
        </group>
        <group group_id="E2">
          <title>DFD-03 Vehicle (0% Tazarotene)</title>
          <description>DFD-03 Vehicle Lotion (0% tazarotene) was to be applied twice daily for 12 weeks</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDra</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="275"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="272"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="275"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="272"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA 20.0">Stomach Ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="275"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="272"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Auto Accident with head trauma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="275"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="272"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="275"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="272"/>
              </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, Senior Director, Clinical Development</name_or_title>
      <organization>Dr. Reddy's Laboratoris, 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/NCT03292640
org study id: DFD-03-CD-006
nct id: NCT03292640
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
Enrollment of subjects with mild to moderate facial acne vulgaris.

      Co-Primary efficacy endpoints included:

        -  Absolute change from Baseline to Week 12 in the inflammatory lesion counts on the face

        -  Absolute change from Baseline to Week 12 in the non-inflammatory lesion counts on the
           face

        -  Proportion of subjects with a clinical response of "success" at Week 12 for lesions on
           the face. Success based on IGA is defined as an IGA score of 0 (Clear) or 1 (Almost
           clear) at Week 12 with at least a 2-grade reduction from Baseline.
Enrollment of subjects with mild to moderate facial acne vulgaris. 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 with approximately 12 hours between applications. Subjects were
      instructed to treat the entire face (and chest/back including shoulders, if applicable).

      Co-Primary efficacy endpoints included:

        -  Absolute change from Baseline to Week 12 in the inflammatory lesion counts on the face

        -  Absolute change from Baseline to Week 12 in the non-inflammatory lesion counts on the
           face

        -  Proportion of subjects with a clinical response of "success" at Week 12 for lesions on
           the face. Success based on IGA is defined as an IGA score of 0 (Clear) or 1 (Almost
           clear) at Week 12 with at least a 2-grade reduction from Baseline.

      The primary safety endpoint was treatment-emergent adverse events (TEAEs). Other safety
      variables included local cutaneous tolerance evaluation (dryness, non-lesional erythema,
      peeling, stinging, burning, and itching) and vital signs (blood pressure and pulse rate).
      Urine pregnancy tests were performed at Baseline and at every visit through Week 12 for all
      female subjects. A physical examination was performed at the Baseline Visit.
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
measure: Proportion of Subjects With a Clinical Response of "Success" at Week 12 for Lesions on the Face Based on IGA.
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)
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 ANCOVA model
arm group label: DFD-03 Lotion (0.1% tazarotene)
arm group type: Experimental
description: DFD-03 Lotion (0.1% tazarotene)
arm group label: DFD-03 Vehicle (0% tazarotene)
arm group type: Placebo Comparator
description: DFD-03 Vehicle Lotion (0% tazarotene)
intervention type: Drug
intervention name: DFD-03 (0.1% tazarotene) Lotion
description: DFD-03 Lotion (0.1% tazarotene) - twice daily application
arm group label: DFD-03 Lotion (0.1% tazarotene)
other name: DFD-03
intervention type: Drug
intervention name: DFD-03 (0% tazarotene) Lotion (Placebo)
description: DFD-03 Vehicle Lotion (0% tazarotene) - twice daily application
arm group label: DFD-03 Vehicle (0% tazarotene)
other name: Placebo
criteria: 
gender: All
minimum age: 9 Years
maximum age: N/A
healthy volunteers: No
last name: Srinivas R. Sidgiddi, M.D.
role: Study Director
affiliation: Dr. Reddy's Laboratories
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acne Vulgaris
mesh term: Nicotinic Acids
mesh term: Tazarotene
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 