<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/NCT03003247</url>
  </required_header>
  <id_info>
    <org_study_id>V01-120A-201</org_study_id>
    <nct_id>NCT03003247</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris</brief_title>
  <official_title>A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle- Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bausch Health Americas, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bausch Health Americas, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle- Controlled, Parallel-Group,&#xD;
      Clinical Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne&#xD;
      Vulgaris&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2015</start_date>
  <completion_date type="Actual">September 30, 2016</completion_date>
  <primary_completion_date type="Actual">August 31, 2016</primary_completion_date>
  <phase>Phase 2</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 of subjects achieving clear or almost clear on the Evaluator's Global Severity Score.</measure>
    <time_frame>12 Weeks</time_frame>
    <description>Percent of subjects who achieve at least a two-grade reduction from Baseline and are Clear or Almost Clear at Week 12 in the Evaluator's Global Severity Score.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">364</enrollment>
  <condition>Acne Vulgaris</condition>
  <arm_group>
    <arm_group_label>IDP-120 Gel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IDP-120 Gel is a combination treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IDP-120 Component A Gel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>IDP-120 Monad Gel of Component A</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IDP-120 Component B Gel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>IDP-120 Monad Gel of Component B</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IDP-120 Vehicle Gel</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>IDP-120 Vehicle Gel</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IDP-120 Gel</intervention_name>
    <description>IDP-120 Gel is a combination product</description>
    <arm_group_label>IDP-120 Gel</arm_group_label>
    <other_name>Component A + B</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IDP 120 Component A Gel</intervention_name>
    <description>Monad of Component A</description>
    <arm_group_label>IDP-120 Component A Gel</arm_group_label>
    <other_name>Component A</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IDP 120 Component B Gel</intervention_name>
    <description>Monad of Component B</description>
    <arm_group_label>IDP-120 Component B Gel</arm_group_label>
    <other_name>Component B</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IDP 120 Vehicle Gel</intervention_name>
    <description>Vehicle</description>
    <arm_group_label>IDP-120 Vehicle Gel</arm_group_label>
    <other_name>Vehicle</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Male or female at least 9 years of age and older;&#xD;
&#xD;
          -  Written and verbal informed consent must be obtained. Subjects less than age of&#xD;
             consent must sign an assent for the study and a parent or a legal guardian must sign&#xD;
             the informed consent (if subject reaches age of consent during the study they should&#xD;
             be re-consented at the next study visit)&#xD;
&#xD;
          -  Pre-menses females and women of childbearing potential must have a negative urine&#xD;
             pregnancy test at screening visit, and a negative urine pregnancy test at baseline&#xD;
             visit.&#xD;
&#xD;
          -  Subjects must be willing to comply with study instructions and return to the clinic&#xD;
             for required visits. Subjects under the age of consent must be accompanied by the&#xD;
             parent or legal guardian at the time of assent/consent signing.&#xD;
&#xD;
          -  If a cleanser, moisturizer or sunscreen is needed during the study, Subjects must be&#xD;
             willing to use only allowed cleansers, moisturizers, sunscreens, or&#xD;
             moisturizer/sunscreen combination products. If the subject wears makeup they must&#xD;
             agree to use non-comedogenic makeup.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Use of an investigational drug or device within 30 days of enrollment or participation&#xD;
             in a research study concurrent with this study.&#xD;
&#xD;
          -  Any dermatological conditions on the face that could interfere with clinical&#xD;
             evaluations such as acne conglobata, acne fulminans, secondary acne, perioral&#xD;
             dermatitis, clinically significant rosacea, gramnegative folliculitis.&#xD;
&#xD;
          -  Any underlying disease(s) or some other dermatological condition of the face that&#xD;
             requires the use of interfering topical or systemic therapy or makes evaluations and&#xD;
             lesion count inconclusive.&#xD;
&#xD;
          -  Subjects with a facial beard or mustache that could interfere with the study&#xD;
             assessments.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anya Loncaric</last_name>
    <role>Study Director</role>
    <affiliation>Valeant Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Valeant Site 15</name>
      <address>
        <city>Encino</city>
        <state>California</state>
        <zip>91316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valeant Site 13</name>
      <address>
        <city>Lake Mary</city>
        <state>Florida</state>
        <zip>32746</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valeant Site 16</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valeant Site 14</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valeant Site 02</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valeant Site 21</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30302</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valeant Site 23</name>
      <address>
        <city>South Bend</city>
        <state>Indiana</state>
        <zip>46601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valeant Site 09</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valeant Site 24</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valeant Site 11</name>
      <address>
        <city>Saint Joseph</city>
        <state>Missouri</state>
        <zip>64502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valreant Site 05</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valeant Site 06</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10002</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valeant Site 01</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27517</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valeant Site 17</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27268</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valeant Site 22</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43085</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valeant Site 04</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valeant Site 07</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>73301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valeant Site 12</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valeant Site 18</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valeant Site 25</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valeant Site 10</name>
      <address>
        <city>Winnepeg</city>
        <state>Manitoba</state>
        <zip>R2C 0A1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valeant Site 03</name>
      <address>
        <city>Markham</city>
        <state>Ontario</state>
        <zip>L3P 0A1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valeant Site 08</name>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <zip>N2J 1L9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valeant Site 20</name>
      <address>
        <city>Windsor</city>
        <state>Ontario</state>
        <zip>N9A 2S6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>May 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <disposition_first_submitted>December 13, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>December 14, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 18, 2017</disposition_first_posted>
  <last_update_submitted>December 14, 2017</last_update_submitted>
  <last_update_submitted_qc>December 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 18, 2017</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT03003247
org study id: V01-120A-201
nct id: NCT03003247
lead sponsor: 
has dmc: No
Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris
A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle- Controlled, Parallel-Group,
      Clinical Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne
      Vulgaris
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percent of subjects achieving clear or almost clear on the Evaluator's Global Severity Score.
time frame: 12 Weeks
description: Percent of subjects who achieve at least a two-grade reduction from Baseline and are Clear or Almost Clear at Week 12 in the Evaluator's Global Severity Score.
arm group label: IDP-120 Gel
arm group type: Experimental
description: IDP-120 Gel is a combination treatment
arm group label: IDP-120 Component A Gel
arm group type: Active Comparator
description: IDP-120 Monad Gel of Component A
arm group label: IDP-120 Component B Gel
arm group type: Active Comparator
description: IDP-120 Monad Gel of Component B
arm group label: IDP-120 Vehicle Gel
arm group type: Placebo Comparator
description: IDP-120 Vehicle Gel
intervention type: Drug
intervention name: IDP-120 Gel
description: IDP-120 Gel is a combination product
arm group label: IDP-120 Gel
other name: Component A + B
intervention type: Drug
intervention name: IDP 120 Component A Gel
description: Monad of Component A
arm group label: IDP-120 Component A Gel
other name: Component A
intervention type: Drug
intervention name: IDP 120 Component B Gel
description: Monad of Component B
arm group label: IDP-120 Component B Gel
other name: Component B
intervention type: Drug
intervention name: IDP 120 Vehicle Gel
description: Vehicle
arm group label: IDP-120 Vehicle Gel
other name: Vehicle
criteria: 
gender: All
minimum age: 9 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Anya Loncaric
role: Study Director
affiliation: Valeant Pharmaceuticals
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country: Canada
country: United States
responsible party type: Sponsor
mesh term: Acne Vulgaris
sharing ipd: Yes