<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/NCT02249767</url>
  </required_header>
  <id_info>
    <org_study_id>Tret.2014.10.01.14</org_study_id>
    <nct_id>NCT02249767</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study of Tretinoin Gel 0.05% to Brand Tretinoin Gel</brief_title>
  <official_title>Bioequivalence Study of Tretinoin Gel 0.05% to Brand Tretinoin Gel</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spear Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Spear Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was a double-blind, randomized, three-treatment, parallel study. Normal, healthy male&#xD;
      and female children and adults (i.e., ages 12 to 40 years) with at least Grade 2 (i.e., mild&#xD;
      severity) acne vulgaris were treated on the full face once daily for 84 days with the&#xD;
      Tretinoin Gel 0.05%, Brand (tretinoin) Gel 0.05%, or Gel Vehicle. Acne lesions were graded by&#xD;
      a single blinded observer at screening and at Weeks 0 (i.e., baseline), 2, 4, 8, and 12 at&#xD;
      each location.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a double-blind, randomized, three-treatment, parallel study conducted at three&#xD;
      locations with a single investigator. Normal, healthy male and female children and adults&#xD;
      (i.e., ages 12 to 40 years) with at least Grade 2 (i.e., mild severity) acne vulgaris were&#xD;
      treated on the full face once daily for 84 days with the Tretinoin Gel 0.05%, Brand&#xD;
      (tretinoin) Gel 0.05%, or Gel Vehicle. Acne lesions were graded by a single blinded observer&#xD;
      at screening and at Weeks 0 (i.e., baseline), 2, 4, 8, and 12 at each location.&#xD;
&#xD;
      The assigned study treatment was self-applied topically once daily for 84 consecutive days.&#xD;
      Scheduled study visits included:&#xD;
&#xD;
        -  Visit 1 (Baseline Visit, Day 0)&#xD;
&#xD;
        -  Visit 2 (First Interim Visit, Day 14)&#xD;
&#xD;
        -  Visit 3 (Second Interim Visit, Day 28)&#xD;
&#xD;
        -  Visit 4 (Third Interim Visit, Day 56)&#xD;
&#xD;
        -  Visit 5 (Forth Interim Visit, Day 84)&#xD;
&#xD;
      A window of ± 4 days was considered acceptable for each scheduled visit following the&#xD;
      Baseline Visit. Subjects were admitted into the study if they had a clinical diagnosis of&#xD;
      acne vulgaris and if they met the inclusion/exclusion criteria. During the study visits, the&#xD;
      following procedures were performed:&#xD;
&#xD;
        -  Counts of inflammatory, non-inflammatory, and nodulocystic lesions&#xD;
&#xD;
        -  The Investigator's Global Assessment (IGA)&#xD;
&#xD;
        -  Assessment of application site reactions Safety was assessed by the monitoring of AEs&#xD;
           and documenting signs and/or symptoms of application site reactions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2013</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</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>Percent Change in Baseline Acne Lesions at Week 12</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Percent change in baseline in inflammatory and non-inflammatory lesions at week 12.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">574</enrollment>
  <condition>Acne</condition>
  <arm_group>
    <arm_group_label>Generic Tretinoin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment of acne once daily over 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brand Tretinoin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment of Acne once daily over 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Treatment of acne once daily over 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tretinoin</intervention_name>
    <description>Treatment of acne once daily in evening</description>
    <arm_group_label>Brand Tretinoin</arm_group_label>
    <arm_group_label>Generic Tretinoin</arm_group_label>
    <arm_group_label>Placebo Vehicle</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normal, healthy male and female children and adults aged 12 to 40 years&#xD;
&#xD;
          -  Written and verbal informed consent had to be obtained. Subjects aged 12 to 17 years,&#xD;
             had to sign an assent for the study and a parent or a legal guardian had to sign the&#xD;
             informed consent&#xD;
&#xD;
          -  Women of childbearing potential had to be non-pregnant and non-nursing, and had to be&#xD;
             willing to avoid pregnancy during the course of the study and during the menstrual&#xD;
             cycle following completion of their participation in the study. Adequate contraception&#xD;
             was defined as systemic birth control, such as oral contraceptives, for three months&#xD;
             prior and implantable/injectable contraceptives (e.g., Norplant, intrauterine device&#xD;
             [IUD]) for six months prior to study drug administration; or barrier methods, such as&#xD;
             diaphragm plus spermicide or condom plus spermicide, consistently for at least 14 days&#xD;
             prior to study drug administration; or abstinence.&#xD;
&#xD;
          -  On the face, having ≥ 20 inflammatory (i.e., papules and pustules) and ≥ 25&#xD;
             non-inflammatory (i.e., open and closed comedones) lesions with ≤ 2 nodulocystic&#xD;
             lesions (i.e, nodules and cysts), as per FDA Draft Guidance on Tretinoin, dated March&#xD;
             20&#xD;
&#xD;
          -  Able to refrain from the use of all other topical acne medications or antibiotics&#xD;
             during the treatment period&#xD;
&#xD;
          -  Considered reliable and capable of understanding their responsibility and role in the&#xD;
             study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of any skin condition that would interfere with the diagnosis or assessment&#xD;
             of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell&#xD;
             carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid&#xD;
             folliculitis, or bacterial folliculitis). Note: Eczema and psoriasis on the body are&#xD;
             not exclusions.&#xD;
&#xD;
          -  Subjects with active cystic acne as evidenced by more than 2 facial nodules. Nodules&#xD;
             are defined as in 7.3.3 as: deep-seated in the skin (i.e., centered in the dermis or&#xD;
             subcutis) and greater than 5 mm in diameter.&#xD;
&#xD;
          -  More than 40 papules and/or pustules (inflammatory lesions).&#xD;
&#xD;
          -  More than 60 open and/or closed comedones/milia (non-inflammatory lesions).&#xD;
&#xD;
          -  Overall severity grade of less than 2 or greater than 4.&#xD;
&#xD;
          -  History of allergy or hypersensitivity to tretinoin, retinoids, or any of the study&#xD;
             medication ingredients.&#xD;
&#xD;
          -  Significant history or clinical evidence of auto-immune, cardiovascular,&#xD;
             gastrointestinal, hematological, hepatic, neurological, pancreatic, or renal disease.&#xD;
&#xD;
          -  Use within 6 months prior to baseline of systemic retinoid (isotretinoin) treatment or&#xD;
             therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are&#xD;
             allowed).&#xD;
&#xD;
          -  Oral contraceptives started or changed within 3 months prior to study initiation or&#xD;
             planned to change during the study.&#xD;
&#xD;
          -  Use on the face within 1 month prior to baseline of 1) cryodestruction or&#xD;
             chemodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5)&#xD;
             intralesional steroids, or 6) x-ray therapy.&#xD;
&#xD;
          -  Use within 1 month prior to baseline of 1) spironolactone, 2) systemic steroids, 3)&#xD;
             systemic antibiotics, 4) systemic treatment for acne vulgaris (other than oral&#xD;
             retinoids, which require a 6-month washout), or 5) systemic anti-inflammatory agents.&#xD;
&#xD;
          -  Use within 2 weeks prior to baseline of 1) topical steroids, 2) topical retinoids, 3)&#xD;
             topical acne treatments including over-the-counter preparations, 4) topical&#xD;
             anti-inflammatory agents, or 5) topical antibiotics.&#xD;
&#xD;
          -  Pregnant or breast-feeding.&#xD;
&#xD;
          -  Serious psychological illness.&#xD;
&#xD;
          -  Significant history (within the past year) of alcohol or drug abuse.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan Barker, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Moore Clinical Research</affiliation>
  </overall_official>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <results_first_submitted>December 28, 2019</results_first_submitted>
  <results_first_submitted_qc>December 28, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 13, 2020</results_first_posted>
  <last_update_submitted>January 24, 2020</last_update_submitted>
  <last_update_submitted_qc>January 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tretinoin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Generic Tretinoin</title>
          <description>Treatment of acne once daily over 12 weeks&#xD;
Tretinoin: Treatment of acne once daily in evening</description>
        </group>
        <group group_id="P2">
          <title>Brand Tretinoin</title>
          <description>Treatment of Acne once daily over 12 weeks&#xD;
Tretinoin: Treatment of acne once daily in evening</description>
        </group>
        <group group_id="P3">
          <title>Placebo Vehicle</title>
          <description>Treatment of acne once daily over 12 weeks&#xD;
Tretinoin: Treatment of acne once daily in evening</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="230"/>
                <participants group_id="P2" count="229"/>
                <participants group_id="P3" count="115"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="222"/>
                <participants group_id="P2" count="220"/>
                <participants group_id="P3" count="107"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Did not use medication</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Generic Tretinoin</title>
          <description>Treatment of acne once daily over 12 weeks&#xD;
Tretinoin: Treatment of acne once daily in evening</description>
        </group>
        <group group_id="B2">
          <title>Brand Tretinoin</title>
          <description>Treatment of Acne once daily over 12 weeks&#xD;
Tretinoin: Treatment of acne once daily in evening</description>
        </group>
        <group group_id="B3">
          <title>Placebo Vehicle</title>
          <description>Treatment of acne once daily over 12 weeks&#xD;
Tretinoin: Treatment of acne once daily in evening</description>
        </group>
        <group group_id="B4">
          <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="222"/>
            <count group_id="B2" value="220"/>
            <count group_id="B3" value="107"/>
            <count group_id="B4" value="549"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="20.1" spread="7.06"/>
                    <measurement group_id="B2" value="20.1" spread="7.60"/>
                    <measurement group_id="B3" value="19.6" spread="7.31"/>
                    <measurement group_id="B4" value="20.0" spread="7.32"/>
                  </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="124"/>
                    <measurement group_id="B2" value="131"/>
                    <measurement group_id="B3" value="64"/>
                    <measurement group_id="B4" value="319"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="98"/>
                    <measurement group_id="B2" value="89"/>
                    <measurement group_id="B3" value="43"/>
                    <measurement group_id="B4" value="230"/>
                  </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="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="127"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="111"/>
                    <measurement group_id="B2" value="109"/>
                    <measurement group_id="B3" value="61"/>
                    <measurement group_id="B4" value="281"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="126"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="4"/>
                  </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="222"/>
                    <measurement group_id="B2" value="220"/>
                    <measurement group_id="B3" value="107"/>
                    <measurement group_id="B4" value="549"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change in Baseline Acne Lesions at Week 12</title>
        <description>Percent change in baseline in inflammatory and non-inflammatory lesions at week 12.</description>
        <time_frame>Baseline and 12 weeks</time_frame>
        <population>This is Per protocol population (PP) Analysis. Generic Tretinoin Intent to Treat (ITT) started 222- 22 excluded as not following protocol= 200 PP. Brand Tretinoin 220 ITT - 11 excluded not following Protocol=209 PP. Placebo 107 ITT - 7 excluded = 100 PP Percent change from baseline in acne lesions</population>
        <group_list>
          <group group_id="O1">
            <title>Generic Tretinoin</title>
            <description>Treatment of acne once daily over 12 weeks&#xD;
Tretinoin: Treatment of acne once daily in evening</description>
          </group>
          <group group_id="O2">
            <title>Brand Tretinoin</title>
            <description>Treatment of Acne once daily over 12 weeks&#xD;
Tretinoin: Treatment of acne once daily in evening</description>
          </group>
          <group group_id="O3">
            <title>Placebo Vehicle</title>
            <description>Treatment of acne once daily over 12 weeks&#xD;
Tretinoin: Treatment of acne once daily in evening</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Baseline Acne Lesions at Week 12</title>
          <description>Percent change in baseline in inflammatory and non-inflammatory lesions at week 12.</description>
          <population>This is Per protocol population (PP) Analysis. Generic Tretinoin Intent to Treat (ITT) started 222- 22 excluded as not following protocol= 200 PP. Brand Tretinoin 220 ITT - 11 excluded not following Protocol=209 PP. Placebo 107 ITT - 7 excluded = 100 PP Percent change from baseline in acne lesions</population>
          <units>Percent reduction</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
                <count group_id="O2" value="209"/>
                <count group_id="O3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-32.34" spread="30.35"/>
                    <measurement group_id="O2" value="-37.32" spread="28.81"/>
                    <measurement group_id="O3" value="-26.38" spread="32.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks</time_frame>
      <desc>Treatment related irritation</desc>
      <group_list>
        <group group_id="E1">
          <title>Generic Tretinoin</title>
          <description>Treatment of acne once daily over 12 weeks&#xD;
Tretinoin: Treatment of acne once daily in evening</description>
        </group>
        <group group_id="E2">
          <title>Brand Tretinoin</title>
          <description>Treatment of Acne once daily over 12 weeks&#xD;
Tretinoin: Treatment of acne once daily in evening</description>
        </group>
        <group group_id="E3">
          <title>Placebo Vehicle</title>
          <description>Treatment of acne once daily over 12 weeks&#xD;
Tretinoin: Treatment of acne once daily in evening</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="230"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="230"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="115"/>
              </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="49" subjects_at_risk="230"/>
                <counts group_id="E2" subjects_affected="46" subjects_at_risk="229"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Irritation from Drug</sub_title>
                <description>Irritation from drug as expected</description>
                <counts group_id="E1" subjects_affected="49" subjects_at_risk="230"/>
                <counts group_id="E2" subjects_affected="46" subjects_at_risk="229"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="115"/>
              </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>With OK from Sponsor</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Spear</name_or_title>
      <organization>Spear Pharmaceuticals</organization>
      <phone>239-560-2411</phone>
      <email>spear@spearpharm.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/NCT02249767
org study id: Tret.2014.10.01.14
nct id: NCT02249767
lead sponsor: 
has dmc: Yes
This was a double-blind, randomized, three-treatment, parallel study. Normal, healthy male
      and female children and adults (i.e., ages 12 to 40 years) with at least Grade 2 (i.e., mild
      severity) acne vulgaris were treated on the full face once daily for 84 days with the
      Tretinoin Gel 0.05%, Brand (tretinoin) Gel 0.05%, or Gel Vehicle. Acne lesions were graded by
      a single blinded observer at screening and at Weeks 0 (i.e., baseline), 2, 4, 8, and 12 at
      each location.
This was a double-blind, randomized, three-treatment, parallel study conducted at three
      locations with a single investigator. Normal, healthy male and female children and adults
      (i.e., ages 12 to 40 years) with at least Grade 2 (i.e., mild severity) acne vulgaris were
      treated on the full face once daily for 84 days with the Tretinoin Gel 0.05%, Brand
      (tretinoin) Gel 0.05%, or Gel Vehicle. Acne lesions were graded by a single blinded observer
      at screening and at Weeks 0 (i.e., baseline), 2, 4, 8, and 12 at each location.

      The assigned study treatment was self-applied topically once daily for 84 consecutive days.
      Scheduled study visits included:

        -  Visit 1 (Baseline Visit, Day 0)

        -  Visit 2 (First Interim Visit, Day 14)

        -  Visit 3 (Second Interim Visit, Day 28)

        -  Visit 4 (Third Interim Visit, Day 56)

        -  Visit 5 (Forth Interim Visit, Day 84)

      A window of ± 4 days was considered acceptable for each scheduled visit following the
      Baseline Visit. Subjects were admitted into the study if they had a clinical diagnosis of
      acne vulgaris and if they met the inclusion/exclusion criteria. During the study visits, the
      following procedures were performed:

        -  Counts of inflammatory, non-inflammatory, and nodulocystic lesions

        -  The Investigator's Global Assessment (IGA)

        -  Assessment of application site reactions Safety was assessed by the monitoring of AEs
           and documenting signs and/or symptoms of application site reactions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percent Change in Baseline Acne Lesions at Week 12
time frame: Baseline and 12 weeks
description: Percent change in baseline in inflammatory and non-inflammatory lesions at week 12.
arm group label: Generic Tretinoin
arm group type: Active Comparator
description: Treatment of acne once daily over 12 weeks
arm group label: Brand Tretinoin
arm group type: Active Comparator
description: Treatment of Acne once daily over 12 weeks
arm group label: Placebo Vehicle
arm group type: Placebo Comparator
description: Treatment of acne once daily over 12 weeks
intervention type: Drug
intervention name: Tretinoin
description: Treatment of acne once daily in evening
arm group label: Brand Tretinoin
arm group label: Generic Tretinoin
arm group label: Placebo Vehicle
other name: Placebo
criteria: 
gender: All
minimum age: 12 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Susan Barker, MD
role: Principal Investigator
affiliation: Moore Clinical Research
responsible party type: Sponsor
mesh term: Tretinoin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 