<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/NCT03271021</url>
  </required_header>
  <id_info>
    <org_study_id>FX2017-22</org_study_id>
    <nct_id>NCT03271021</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris</brief_title>
  <official_title>A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne Vulgaris (Study FX2017-22)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vyne Therapeutics Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vyne Therapeutics Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of&#xD;
      Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne&#xD;
      Vulgaris (Study FX2017-22)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate&#xD;
      the safety and efficacy over 12 weeks of FMX101 topical foam containing 4% minocycline&#xD;
      compared to vehicle in the treatment of subjects with moderate-to-severe facial acne&#xD;
      vulgaris. Qualified subjects will be randomized to receive 1 of the following 2 treatments:&#xD;
&#xD;
        -  FMX101 4% minocycline foam&#xD;
&#xD;
        -  Vehicle foam&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 17, 2017</start_date>
  <completion_date type="Actual">September 4, 2018</completion_date>
  <primary_completion_date type="Actual">September 4, 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>The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12.</measure>
    <time_frame>12 weeks</time_frame>
    <description>A decrease in the inflammatory lesion count from Baseline to Week 12.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Investigator Global Assessment (IGA) Treatment Success (Dichotomized as Yes/no) at Week 12, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9</measure>
    <time_frame>9 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IGA Treatment Success (Dichotomized as Yes/no) at Week 6, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 6</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IGA Treatment Success (Dichotomized as Yes/no) at Week 9, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 9</measure>
    <time_frame>9 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1488</enrollment>
  <condition>Acne Vulgaris</condition>
  <arm_group>
    <arm_group_label>FMX101, 4% minocycline foam</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FMX101, 4% minocycline foam applied topically once daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle foam</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Vehicle foam applied topically once daily for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FMX101</intervention_name>
    <description>FMX101, 4% minocycline foam</description>
    <arm_group_label>FMX101, 4% minocycline foam</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vehicle Foam</intervention_name>
    <description>Vehicle Foam</description>
    <arm_group_label>Vehicle foam</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Has facial acne vulgaris with:&#xD;
&#xD;
               1. 20 to 50 inflammatory lesions (papules, pustules, and nodules)&#xD;
&#xD;
               2. 25 to 100 non-inflammatory lesions (open and closed comedones)&#xD;
&#xD;
               3. No more than 2 nodules on the face&#xD;
&#xD;
               4. IGA score of moderate (3) to severe (4)&#xD;
&#xD;
          2. Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin&#xD;
             Cleanser) and to refrain from use of any other acne medication, medicated cleanser,&#xD;
             excessive sun exposure, and tanning booths for the duration of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any&#xD;
             dermatological condition of the face or facial hair (eg, beard, sideburns, mustache)&#xD;
             that could interfere with the clinical evaluations.&#xD;
&#xD;
          2. Sunburn on the face.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Foamix Investigational Site #376</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #395</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #315</name>
      <address>
        <city>Bryant</city>
        <state>Arkansas</state>
        <zip>72022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #340</name>
      <address>
        <city>Fort Smith</city>
        <state>Arkansas</state>
        <zip>72916</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational SIte #377</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #366</name>
      <address>
        <city>Encino</city>
        <state>California</state>
        <zip>91436</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #403</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #303</name>
      <address>
        <city>Murrieta</city>
        <state>California</state>
        <zip>92562</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #369</name>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <zip>91324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #387</name>
      <address>
        <city>Palm Springs</city>
        <state>California</state>
        <zip>92262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #393</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #380</name>
      <address>
        <city>Poway</city>
        <state>California</state>
        <zip>92064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site # 328</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95819</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #313</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #336</name>
      <address>
        <city>San Luis Obispo</city>
        <state>California</state>
        <zip>93405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #309</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #325</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #375</name>
      <address>
        <city>Temecula</city>
        <state>California</state>
        <zip>92592</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #381</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational SIte #371</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33431</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #311</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #398</name>
      <address>
        <city>Brandon</city>
        <state>Florida</state>
        <zip>33511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #329</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #378</name>
      <address>
        <city>Davie</city>
        <state>Florida</state>
        <zip>33328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #396</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #392</name>
      <address>
        <city>Doral</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #318</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #401</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #400</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #383</name>
      <address>
        <city>Lake Worth</city>
        <state>Florida</state>
        <zip>33467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #346</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #347</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #397</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #370</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #306</name>
      <address>
        <city>North Miami Beach</city>
        <state>Florida</state>
        <zip>33162</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #312</name>
      <address>
        <city>Ormond Beach</city>
        <state>Florida</state>
        <zip>32174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #362</name>
      <address>
        <city>South Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational SIte #382</name>
      <address>
        <city>Tamarac</city>
        <state>Florida</state>
        <zip>33321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #399</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #385</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33624</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #394</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33634</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #360</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #368</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #336</name>
      <address>
        <city>Sandy Springs</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #384</name>
      <address>
        <city>Nampa</city>
        <state>Idaho</state>
        <zip>83651</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #345</name>
      <address>
        <city>Skokie</city>
        <state>Illinois</state>
        <zip>60077</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #390</name>
      <address>
        <city>West Dundee</city>
        <state>Illinois</state>
        <zip>60118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #365</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #316</name>
      <address>
        <city>New Albany</city>
        <state>Indiana</state>
        <zip>47150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #361</name>
      <address>
        <city>Plainfield</city>
        <state>Indiana</state>
        <zip>46168</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #331</name>
      <address>
        <city>South Bend</city>
        <state>Indiana</state>
        <zip>46617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #320</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational SIte #367</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #317</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational SIte #373</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #388</name>
      <address>
        <city>Glenn Dale</city>
        <state>Maryland</state>
        <zip>20769</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #304</name>
      <address>
        <city>Beverly</city>
        <state>Massachusetts</state>
        <zip>01915</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #314</name>
      <address>
        <city>Brighton</city>
        <state>Massachusetts</state>
        <zip>02135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #334</name>
      <address>
        <city>Watertown</city>
        <state>Massachusetts</state>
        <zip>02472</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #322</name>
      <address>
        <city>Saint Joseph</city>
        <state>Missouri</state>
        <zip>64506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #372</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #391</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site # 327</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #332</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89728</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #344</name>
      <address>
        <city>Portsmouth</city>
        <state>New Hampshire</state>
        <zip>03801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #356</name>
      <address>
        <city>Berlin</city>
        <state>New Jersey</state>
        <zip>08009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #337</name>
      <address>
        <city>Verona</city>
        <state>New Jersey</state>
        <zip>07044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #321</name>
      <address>
        <city>Charlotte</city>
        <state>New York</state>
        <zip>28277</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #355</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #363</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #307</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #350</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28277</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #348</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #364</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #310</name>
      <address>
        <city>Bexley</city>
        <state>Ohio</state>
        <zip>43209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #386</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #353</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #330</name>
      <address>
        <city>Dublin</city>
        <state>Ohio</state>
        <zip>43016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #302</name>
      <address>
        <city>Norman</city>
        <state>Oklahoma</state>
        <zip>73071</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #335</name>
      <address>
        <city>Exton</city>
        <state>Pennsylvania</state>
        <zip>19341</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #349</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #323</name>
      <address>
        <city>Jenkintown</city>
        <state>Pennsylvania</state>
        <zip>19046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #319</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #305</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #308</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37922</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Research Site # 301</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #374</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational SIte #341</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #351</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #402</name>
      <address>
        <city>Bryan</city>
        <state>Texas</state>
        <zip>77802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #358</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #333</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #352</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site # 324</name>
      <address>
        <city>Pflugerville</city>
        <state>Texas</state>
        <zip>78660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational SIte #379</name>
      <address>
        <city>Lynchburg</city>
        <state>Virginia</state>
        <zip>24501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #343</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>235070</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #389</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98168</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foamix Investigational Site #359</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <results_first_submitted>January 16, 2020</results_first_submitted>
  <results_first_submitted_qc>February 10, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 21, 2020</results_first_posted>
  <last_update_submitted>January 13, 2022</last_update_submitted>
  <last_update_submitted_qc>January 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2022</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>Minocycline</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 22, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT03271021/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 17, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT03271021/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>FMX101, 4% Minocycline Foam</title>
          <description>FMX101, 4% minocycline foam applied topically once daily for 12 weeks&#xD;
FMX101: FMX101, 4% minocycline foam</description>
        </group>
        <group group_id="P2">
          <title>Vehicle Foam</title>
          <description>Vehicle foam applied topically once daily for 12 weeks&#xD;
Vehicle Foam: Vehicle Foam</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="738"/>
                <participants group_id="P2" count="750"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="649"/>
                <participants group_id="P2" count="644"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="89"/>
                <participants group_id="P2" count="106"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="53"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="39"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Abnormal Lab Results</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Miscellaneous</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>FMX101, 4% Minocycline Foam</title>
          <description>FMX101, 4% minocycline foam applied topically once daily for 12 weeks&#xD;
FMX101: FMX101, 4% minocycline foam</description>
        </group>
        <group group_id="B2">
          <title>Vehicle Foam</title>
          <description>Vehicle foam applied topically once daily for 12 weeks&#xD;
Vehicle Foam: Vehicle Foam</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="738"/>
            <count group_id="B2" value="750"/>
            <count group_id="B3" value="1488"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>9-12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>13-17</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="321"/>
                    <measurement group_id="B2" value="309"/>
                    <measurement group_id="B3" value="630"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="375"/>
                    <measurement group_id="B2" value="400"/>
                    <measurement group_id="B3" value="775"/>
                  </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="460"/>
                    <measurement group_id="B2" value="469"/>
                    <measurement group_id="B3" value="929"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="278"/>
                    <measurement group_id="B2" value="281"/>
                    <measurement group_id="B3" value="559"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="266"/>
                    <measurement group_id="B2" value="252"/>
                    <measurement group_id="B3" value="518"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="472"/>
                    <measurement group_id="B2" value="498"/>
                    <measurement group_id="B3" value="970"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="54"/>
                  </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="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="125"/>
                    <measurement group_id="B2" value="144"/>
                    <measurement group_id="B3" value="269"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="571"/>
                    <measurement group_id="B2" value="560"/>
                    <measurement group_id="B3" value="1131"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12.</title>
        <description>A decrease in the inflammatory lesion count from Baseline to Week 12.</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FMX101, 4% Minocycline Foam</title>
            <description>FMX101, 4% minocycline foam applied topically once daily for 12 weeks&#xD;
FMX101: FMX101, 4% minocycline foam</description>
          </group>
          <group group_id="O2">
            <title>Vehicle Foam</title>
            <description>Vehicle foam applied topically once daily for 12 weeks&#xD;
Vehicle Foam: Vehicle Foam</description>
          </group>
        </group_list>
        <measure>
          <title>The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12.</title>
          <description>A decrease in the inflammatory lesion count from Baseline to Week 12.</description>
          <units>Lesion Count</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="738"/>
                <count group_id="O2" value="750"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.39" lower_limit="15.53" upper_limit="17.25"/>
                    <measurement group_id="O2" value="12.74" lower_limit="11.88" upper_limit="13.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Investigator Global Assessment (IGA) Treatment Success (Dichotomized as Yes/no) at Week 12, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline</title>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FMX101, 4% Minocycline Foam</title>
            <description>FMX101, 4% minocycline foam applied topically once daily for 12 weeks&#xD;
FMX101: FMX101, 4% minocycline foam</description>
          </group>
          <group group_id="O2">
            <title>Vehicle Foam</title>
            <description>Vehicle foam applied topically once daily for 12 weeks&#xD;
Vehicle Foam: Vehicle Foam</description>
          </group>
        </group_list>
        <measure>
          <title>Investigator Global Assessment (IGA) Treatment Success (Dichotomized as Yes/no) at Week 12, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="738"/>
                <count group_id="O2" value="750"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="199"/>
                    <measurement group_id="O2" value="133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12</title>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FMX101, 4% Minocycline Foam</title>
            <description>FMX101, 4% minocycline foam applied topically once daily for 12 weeks&#xD;
FMX101: FMX101, 4% minocycline foam</description>
          </group>
          <group group_id="O2">
            <title>Vehicle Foam</title>
            <description>Vehicle foam applied topically once daily for 12 weeks&#xD;
Vehicle Foam: Vehicle Foam</description>
          </group>
        </group_list>
        <measure>
          <title>The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12</title>
          <units>Lesion Count</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="626"/>
                <count group_id="O2" value="622"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.80" lower_limit="17.06" upper_limit="20.54"/>
                    <measurement group_id="O2" value="15.89" lower_limit="14.14" upper_limit="17.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9</title>
        <time_frame>9 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FMX101, 4% Minocycline Foam</title>
            <description>FMX101, 4% minocycline foam applied topically once daily for 12 weeks&#xD;
FMX101: FMX101, 4% minocycline foam</description>
          </group>
          <group group_id="O2">
            <title>Vehicle Foam</title>
            <description>Vehicle foam applied topically once daily for 12 weeks&#xD;
Vehicle Foam: Vehicle Foam</description>
          </group>
        </group_list>
        <measure>
          <title>The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9</title>
          <units>Lesion Count</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="738"/>
                <count group_id="O2" value="750"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.59" lower_limit="14.80" upper_limit="16.38"/>
                    <measurement group_id="O2" value="11.72" lower_limit="10.92" upper_limit="12.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6</title>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FMX101, 4% Minocycline Foam</title>
            <description>FMX101, 4% minocycline foam applied topically once daily for 12 weeks&#xD;
FMX101: FMX101, 4% minocycline foam</description>
          </group>
          <group group_id="O2">
            <title>Vehicle Foam</title>
            <description>Vehicle foam applied topically once daily for 12 weeks&#xD;
Vehicle Foam: Vehicle Foam</description>
          </group>
        </group_list>
        <measure>
          <title>The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6</title>
          <units>Lesion Count</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="738"/>
                <count group_id="O2" value="750"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.09" lower_limit="12.29" upper_limit="13.89"/>
                    <measurement group_id="O2" value="9.57" lower_limit="8.76" upper_limit="110.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>IGA Treatment Success (Dichotomized as Yes/no) at Week 6, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 6</title>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FMX101, 4% Minocycline Foam</title>
            <description>FMX101, 4% minocycline foam applied topically once daily for 12 weeks&#xD;
FMX101: FMX101, 4% minocycline foam</description>
          </group>
          <group group_id="O2">
            <title>Vehicle Foam</title>
            <description>Vehicle foam applied topically once daily for 12 weeks&#xD;
Vehicle Foam: Vehicle Foam</description>
          </group>
        </group_list>
        <measure>
          <title>IGA Treatment Success (Dichotomized as Yes/no) at Week 6, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 6</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="738"/>
                <count group_id="O2" value="750"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>IGA Treatment Success (Dichotomized as Yes/no) at Week 9, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 9</title>
        <time_frame>9 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FMX101, 4% Minocycline Foam</title>
            <description>FMX101, 4% minocycline foam applied topically once daily for 12 weeks&#xD;
FMX101: FMX101, 4% minocycline foam</description>
          </group>
          <group group_id="O2">
            <title>Vehicle Foam</title>
            <description>Vehicle foam applied topically once daily for 12 weeks&#xD;
Vehicle Foam: Vehicle Foam</description>
          </group>
        </group_list>
        <measure>
          <title>IGA Treatment Success (Dichotomized as Yes/no) at Week 9, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 9</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="738"/>
                <count group_id="O2" value="750"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="137"/>
                    <measurement group_id="O2" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 16 weeks</time_frame>
      <desc>Number of participants represents the Safety Population.</desc>
      <group_list>
        <group group_id="E1">
          <title>FMX101, 4% Minocycline Foam</title>
          <description>FMX101, 4% minocycline foam applied topically once daily for 12 weeks&#xD;
FMX101: FMX101, 4% minocycline foam</description>
        </group>
        <group group_id="E2">
          <title>Vehicle Foam</title>
          <description>Vehicle foam applied topically once daily for 12 weeks&#xD;
Vehicle Foam: Vehicle Foam</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-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="737"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="747"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="737"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="747"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chron's disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="737"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="747"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="737"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="747"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Pregnancy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="737"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="747"/>
              </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="737"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="747"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Director, Clinical Operations</name_or_title>
      <organization>Foamix Pharmaceuticals</organization>
      <phone>9089630117</phone>
      <email>kendra.gulbronson@foamix.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/NCT03271021
org study id: FX2017-22
nct id: NCT03271021
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of
      Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne
      Vulgaris (Study FX2017-22)
This is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate
      the safety and efficacy over 12 weeks of FMX101 topical foam containing 4% minocycline
      compared to vehicle in the treatment of subjects with moderate-to-severe facial acne
      vulgaris. Qualified subjects will be randomized to receive 1 of the following 2 treatments:

        -  FMX101 4% minocycline foam

        -  Vehicle foam
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12.
time frame: 12 weeks
description: A decrease in the inflammatory lesion count from Baseline to Week 12.
measure: Investigator Global Assessment (IGA) Treatment Success (Dichotomized as Yes/no) at Week 12, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline
time frame: 12 weeks
measure: The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12
time frame: 12 weeks
measure: The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9
time frame: 9 weeks
measure: The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6
time frame: 6 weeks
measure: IGA Treatment Success (Dichotomized as Yes/no) at Week 6, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 6
time frame: 6 weeks
measure: IGA Treatment Success (Dichotomized as Yes/no) at Week 9, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 9
time frame: 9 weeks
arm group label: FMX101, 4% minocycline foam
arm group type: Experimental
description: FMX101, 4% minocycline foam applied topically once daily for 12 weeks
arm group label: Vehicle foam
arm group type: Placebo Comparator
description: Vehicle foam applied topically once daily for 12 weeks
intervention type: Drug
intervention name: FMX101
description: FMX101, 4% minocycline foam
arm group label: FMX101, 4% minocycline foam
intervention type: Drug
intervention name: Vehicle Foam
description: Vehicle Foam
arm group label: Vehicle foam
criteria: 
gender: All
minimum age: 9 Years
maximum age: N/A
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Acne Vulgaris
mesh term: Minocycline
provided document: 
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