<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/NCT02218034</url>
  </required_header>
  <id_info>
    <org_study_id>190168-069</org_study_id>
    <nct_id>NCT02218034</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Pharmacokinetics of AGN-190168 in Subjects With Acne Vulgaris</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allergan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a safety, tolerability and pharmacokinetics study of AGN-190168 in subjects with acne&#xD;
      vulgaris.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>Phase 1</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>Basic Science</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Plasma Level (Cmax) of AGN-190168</measure>
    <time_frame>Day 29</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Plasma Level (Cmax) of AGN-190168 Metabolite</measure>
    <time_frame>Day 29</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale</measure>
    <time_frame>Day 29</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Local Dermal Tolerability as Assessed by the Investigator Using a 4-Point Scale</measure>
    <time_frame>Day 29</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Acne Vulgaris</condition>
  <arm_group>
    <arm_group_label>AGN-190168 Formulation 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AGN-190168 Formulation 1 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AGN-190168 Formulation 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AGN-190168 Formulation 2 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAZORAC® Gel 0.1%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TAZORAC® Gel 0.1% (tazarotene gel 0.1%) applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAZORAC® Cream 0.1%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TAZORAC® Cream 0.1% (tazarotene cream 0.1%) applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AGN-190168 Formulation 1</intervention_name>
    <description>AGN-190168 Formulation 1 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.</description>
    <arm_group_label>AGN-190168 Formulation 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AGN-190168 Formulation 2</intervention_name>
    <description>AGN-190168 Formulation 2 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.</description>
    <arm_group_label>AGN-190168 Formulation 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>tazarotene gel 0.1%</intervention_name>
    <description>Tazarotene gel 0.1% applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.</description>
    <arm_group_label>TAZORAC® Gel 0.1%</arm_group_label>
    <other_name>TAZORAC® Gel 0.1%</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>tazarotene cream 0.1%</intervention_name>
    <description>Tazarotene cream 0.1% cream applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.</description>
    <arm_group_label>TAZORAC® Cream 0.1%</arm_group_label>
    <other_name>TAZORAC® Cream 0.1%</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of acne vulgaris on the face&#xD;
&#xD;
          -  No tobacco use for the past 30 days, and willing to refrain from nicotine use during&#xD;
             the study&#xD;
&#xD;
          -  Willing to avoid excessive or prolonged exposure of the treated skin to ultraviolet&#xD;
             light (eg, sunlight, tanning beds) and extremes in weather, such as wind or cold,&#xD;
             throughout the study&#xD;
&#xD;
          -  If male, willing to maintain routine shaving regimen for the duration of the study and&#xD;
             avoid shaving 12 hours prior to specified visits&#xD;
&#xD;
          -  Females of childbearing potential must use a reliable method of contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of phototherapy devices (eg, ClearLight™) and adhesive cleansing strips (eg,&#xD;
             Ponds® and Biore®), as well as cosmetic procedures (eg, facials, peeling, and comedone&#xD;
             extraction) in the area to be treated in the past 1 week&#xD;
&#xD;
          -  Use of topical anti-inflammatory drugs, salicylic acid (eg, Clearasil® and Clean &amp;&#xD;
             Clear®), corticosteroids, antibiotics, antibacterials (including benzoyl&#xD;
             peroxide-containing products [eg, benzamycin]), retinoids, and other topical acne&#xD;
             treatments (eg, photodynamic therapy, laser therapy, and medicated soaps) in the area&#xD;
             to be treated in the past 2 weeks&#xD;
&#xD;
          -  Ability to abstain from caffeine-containing products on the dates instructed&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Allergan</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>College Station</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>April 28, 2015</last_update_submitted>
  <last_update_submitted_qc>April 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 30, 2015</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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02218034
org study id: 190168-069
nct id: NCT02218034
lead sponsor: 
has dmc: No
This is a safety, tolerability and pharmacokinetics study of AGN-190168 in subjects with acne
      vulgaris.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Investigator)
measure: Maximum Plasma Level (Cmax) of AGN-190168
time frame: Day 29
measure: Maximum Plasma Level (Cmax) of AGN-190168 Metabolite
time frame: Day 29
measure: Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale
time frame: Day 29
measure: Local Dermal Tolerability as Assessed by the Investigator Using a 4-Point Scale
time frame: Day 29
arm group label: AGN-190168 Formulation 1
arm group type: Experimental
description: AGN-190168 Formulation 1 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
arm group label: AGN-190168 Formulation 2
arm group type: Experimental
description: AGN-190168 Formulation 2 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
arm group label: TAZORAC® Gel 0.1%
arm group type: Active Comparator
description: TAZORAC® Gel 0.1% (tazarotene gel 0.1%) applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
arm group label: TAZORAC® Cream 0.1%
arm group type: Active Comparator
description: TAZORAC® Cream 0.1% (tazarotene cream 0.1%) applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
intervention type: Drug
intervention name: AGN-190168 Formulation 1
description: AGN-190168 Formulation 1 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
arm group label: AGN-190168 Formulation 1
intervention type: Drug
intervention name: AGN-190168 Formulation 2
description: AGN-190168 Formulation 2 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
arm group label: AGN-190168 Formulation 2
intervention type: Drug
intervention name: tazarotene gel 0.1%
description: Tazarotene gel 0.1% applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
arm group label: TAZORAC® Gel 0.1%
other name: TAZORAC® Gel 0.1%
intervention type: Drug
intervention name: tazarotene cream 0.1%
description: Tazarotene cream 0.1% cream applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
arm group label: TAZORAC® Cream 0.1%
other name: TAZORAC® Cream 0.1%
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Allergan
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acne Vulgaris
mesh term: Nicotinic Acids
mesh term: Tazarotene