<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/NCT03287791</url>
  </required_header>
  <id_info>
    <org_study_id>ACTA/AZEL/2015</org_study_id>
    <nct_id>NCT03287791</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Safety and Equivalence of Generic Azelaic Acid Foam and Finacea® Foam in Participants With Rosacea</brief_title>
  <official_title>A Multicenter, Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled Study to Evaluate Safety and Clinical Equivalence of a Generic Azelaic Acid Foam, 15% and the Reference Listed Finacea® (Azelaic Acid) Foam,15% in Patients With Moderate Facial Rosacea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Actavis Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Actavis 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>
      The objectives of this study were to compare the safety and efficacy profiles of a generic&#xD;
      Azelaic Acid Foam, 15% to the reference listed Finacea® (azelaic acid) Foam, 15% and to&#xD;
      demonstrate therapeutic equivalence and safety of the two active foams in the treatment of&#xD;
      moderate facial rosacea, and to demonstrate superiority of the Reference and Test products&#xD;
      over the Vehicle.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Topical azelaic acid is used to treat inflammatory papules and pustules of mild to moderate&#xD;
      rosacea. Other topical therapies and oral antibiotics are also used to treat rosacea&#xD;
      symptoms. Finacea® (azelaic acid) Foam, 15% contains azelaic acid, a naturally occurring&#xD;
      saturated dicarboxylic acid that has proven anti-inflammatory effects, as well as&#xD;
      anti-keratinizing and antimicrobial actions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 19, 2016</start_date>
  <completion_date type="Actual">June 22, 2017</completion_date>
  <primary_completion_date type="Actual">June 22, 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Change From Baseline in the Inflammatory Lesions (Papules and Pustules) Counts at Week 12</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
    <description>All facial papules, pustules, and nodules, located above the jaw line and extending to the hairline, were counted. When counting facial lesions, lesions present on the nose were included. The total count for each lesion type was recorded and the total number of inflammatory lesions (papules and pustules) were calculated. A papule with a pustule on its apex was counted as a pustule. Counts of nodules and cysts were reported separately and not included in the inflammatory counts. Papule defined as inflammatory lesion; small (≤5 mm in diameter), solid palpable lesion, usually with inflamed elevation of the skin that does not contain pus. Pustule defined as inflammatory lesion; small (≤5 mm in diameter), inflamed skin swelling that is filled with pus. Cyst and nodule defined as palpable solid or soft lesion &gt;5 mm in diameter.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Treatment Success Based on IGE Score</measure>
    <time_frame>Baseline and 12 Weeks</time_frame>
    <description>Treatment success defined as an Investigator's Global Evaluation (IGE) score at Week 12 of 0 (clear) or 1 (almost clear). Any other outcome was considered a failure. Participants who were discontinued prematurely from the study due to lack of treatment effect after at least 8 weeks of compliant treatment were considered as treatment failures. The IGE score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">924</enrollment>
  <condition>Rosacea</condition>
  <arm_group>
    <arm_group_label>Generic Azelaic Acid Foam</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A thin layer of generic azelaic acid, 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Finacea® (Azelaic Acid) Foam</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A thin layer of Finacea (azelaic acid), 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle Foam</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A thin layer of the vehicle topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Generic Azelaic Acid Foam</intervention_name>
    <description>Topical foam, generic formulation of the brand product.</description>
    <arm_group_label>Generic Azelaic Acid Foam</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Finacea® (Azelaic Acid) Foam</intervention_name>
    <description>Topical foam, brand product.</description>
    <arm_group_label>Finacea® (Azelaic Acid) Foam</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vehicle Foam</intervention_name>
    <description>Topical foam, placebo. Has no active ingredient.</description>
    <arm_group_label>Vehicle Foam</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cleanser</intervention_name>
    <description>A mild cleanser provided to participants, so they can wash their face prior to applying the study drug.</description>
    <arm_group_label>Finacea® (Azelaic Acid) Foam</arm_group_label>
    <arm_group_label>Generic Azelaic Acid Foam</arm_group_label>
    <arm_group_label>Vehicle Foam</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sunscreen</intervention_name>
    <description>Sunscreen provided to participants, so they can apply it to their face when outdoors.</description>
    <arm_group_label>Finacea® (Azelaic Acid) Foam</arm_group_label>
    <arm_group_label>Generic Azelaic Acid Foam</arm_group_label>
    <arm_group_label>Vehicle Foam</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Towel</intervention_name>
    <description>A soft towel provided to participants, so they can pat their face dry after washing and prior to applying the study drug.</description>
    <arm_group_label>Finacea® (Azelaic Acid) Foam</arm_group_label>
    <arm_group_label>Generic Azelaic Acid Foam</arm_group_label>
    <arm_group_label>Vehicle Foam</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Moisturizing Lotion</intervention_name>
    <description>Moisturizing lotion provided to participants, so they can apply it to their face, as needed.</description>
    <arm_group_label>Finacea® (Azelaic Acid) Foam</arm_group_label>
    <arm_group_label>Generic Azelaic Acid Foam</arm_group_label>
    <arm_group_label>Vehicle Foam</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants had to be willing and able to provide written informed consent for the&#xD;
             study&#xD;
&#xD;
          -  Healthy males or non-pregnant females ≥18 years-of-age with a clinical diagnosis of&#xD;
             moderate facial rosacea&#xD;
&#xD;
          -  Participants had to have at least 8 and not more than 50 inflammatory facial lesions&#xD;
             (that is, papules/pustules) and ≤2 nodules on the face. For the purposes of study&#xD;
             treatment and evaluation, these lesions were limited to the facial treatment area&#xD;
             including those present on the nose. Lesions involving the eyes and scalp were&#xD;
             excluded from the count.&#xD;
&#xD;
          -  Participants had to have persistent erythema on the face with moderate (3) score&#xD;
&#xD;
          -  Participants had to have a mild (1) to moderate (2) score for telangiectasia on the&#xD;
             face&#xD;
&#xD;
          -  Participants had to have a definite clinical diagnosis of moderate facial rosacea&#xD;
             (severity score 3)&#xD;
&#xD;
          -  Participants had to be willing to minimize external factors that might trigger rosacea&#xD;
             flare-ups (for example, spicy foods, thermally hot foods and drinks, hot environments,&#xD;
             prolonged sun exposure, strong winds, and alcoholic beverages) during the course of&#xD;
             the study&#xD;
&#xD;
          -  Participants had to be in general good health and free from any clinically significant&#xD;
             disease other than rosacea on the face, that could have interfered with the study&#xD;
             evaluations&#xD;
&#xD;
          -  Participants had to be willing and able to understand and comply with the requirements&#xD;
             of the study, apply the medication as instructed, return for the required treatment&#xD;
             period visits, comply with therapy prohibitions, and able to complete the study&#xD;
&#xD;
          -  Male participants and female participants of childbearing potential had to use&#xD;
             accepted methods of birth control or had to agree to practice abstinence, from study&#xD;
             start to 30 days after the last administration of study drug. All female participants&#xD;
             were considered to be of childbearing potential unless they had been surgically&#xD;
             sterilized (hysterectomy, bilateral oophorectomy, or tubal ligation) or had been&#xD;
             postmenopausal for at least a year. Any of the following methods of birth control were&#xD;
             acceptable: oral contraceptives, contraceptive patches/implants (for example,&#xD;
             Norplant®), vaginal ring (NuvaRing®), Depo-Provera® (Medroxy progesterone acetate),&#xD;
             double barrier methods (for example, condom and spermicide), or intrauterine device&#xD;
&#xD;
          -  Female participants of child bearing potential had to have a negative urine pregnancy&#xD;
             test at baseline&#xD;
&#xD;
          -  Participants who used make-up had to have used the same brands/types of make-up for a&#xD;
             minimum period of 14 days prior to study entry and had to agree to use the same&#xD;
             make-up, brand/type, or frequency of use, throughout the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating or planning to become pregnant during the study period&#xD;
&#xD;
          -  Presence of any skin condition on the face that could have interfered with the&#xD;
             diagnosis or assessment of rosacea&#xD;
&#xD;
          -  Excessive facial hair (for example, beards, sideburns, moustaches) that would&#xD;
             interfere could have interfered with diagnosis or assessment of rosacea&#xD;
&#xD;
          -  History of hypersensitivity or allergy to azelaic acid, propylene glycol, or any other&#xD;
             component of the formulation&#xD;
&#xD;
          -  The use within 6 months prior to baseline of oral retinoids (for example, Accutane®)&#xD;
             or therapeutic Vitamin A supplements of greater than 10,000 units/day (multivitamins&#xD;
             were allowed)&#xD;
&#xD;
          -  The use of estrogens or oral contraceptives for less than 3 months prior to baseline&#xD;
&#xD;
          -  The use within 1 month prior to baseline of the following:&#xD;
&#xD;
               -  topical retinoids to the face&#xD;
&#xD;
               -  systemic antibiotics known to have an impact on the severity of facial rosacea&#xD;
                  (for example, containing tetracycline and its derivatives, erythromycin and its&#xD;
                  derivatives, sulfamethoxazole, or trimethoprim)&#xD;
&#xD;
               -  systemic corticosteroids&#xD;
&#xD;
          -  Use within two weeks prior to baseline of the following:&#xD;
&#xD;
               -  topical corticosteroids&#xD;
&#xD;
               -  topical antibiotics&#xD;
&#xD;
               -  topical medications for rosacea (for example, metronidazole, azelaic acid)&#xD;
&#xD;
          -  Antipruritics, including antihistamines, within 24 hours of any study visit&#xD;
&#xD;
          -  Participants with moderate or severe rhinophyma, dense telangiectasia (score 3,&#xD;
             severe), or plaque-like facial edema&#xD;
&#xD;
          -  Participants with a severe irritation grade for erythema, dryness, scaling, pruritus,&#xD;
             stinging/burning, and edema&#xD;
&#xD;
          -  Ocular rosacea (for example, conjunctivitis, blepharitis, or keratitis) of sufficient&#xD;
             severity to require topical or systemic antibiotics&#xD;
&#xD;
          -  A participant who had used a sauna during the 2 weeks prior to study entry and during&#xD;
             the study&#xD;
&#xD;
          -  Participants who had performed wax epilation of the face within 14 days prior to&#xD;
             baseline&#xD;
&#xD;
          -  A participant who had a history of being unresponsive to topical azelaic acid therapy&#xD;
&#xD;
          -  A participant who had any clinically significant condition or situation, other than&#xD;
             the condition being studied that, in the opinion of the Investigator, could have&#xD;
             interfered with the study evaluations or optimal participation in the study&#xD;
&#xD;
          -  A participant who had used any topical azelaic acid therapy within 30 days of baseline&#xD;
             visit&#xD;
&#xD;
          -  Participants who had participated in an investigational drug study (for example,&#xD;
             participants had been treated with an investigational drug) within 30 days prior to&#xD;
             baseline were excluded from study participation. Participants who were participating&#xD;
             in non-treatment studies such as observational studies or registry studies could be&#xD;
             considered for inclusion&#xD;
&#xD;
          -  Participants who had been previously randomized in this study&#xD;
&#xD;
          -  Participants who had laser therapy (for telangiectasia or other conditions) and&#xD;
             phototherapy to the facial area within 180 days prior to study entry&#xD;
&#xD;
          -  Participants who had cosmetic procedures (for example, facials), which could affect&#xD;
             the efficacy and safety profile of the investigational product within 14 days prior to&#xD;
             study entry&#xD;
&#xD;
          -  Employees or staff of the research site were excluded from participation in the study&#xD;
&#xD;
          -  No more than 1 participant from the same household was allowed to participate in the&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Teva Pharmaceuticals USA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigative Site 2</name>
      <address>
        <city>Encino</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 10</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 19</name>
      <address>
        <city>Brandon</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 1</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 9</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 23</name>
      <address>
        <city>Lauderdale Lakes</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 11</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 15</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 20</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 12</name>
      <address>
        <city>Miramar</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 25</name>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 22</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 18</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 16</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 14</name>
      <address>
        <city>Plainfield</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 13</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 6</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 17</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 8</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 3</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 21</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 4</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 26</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 7</name>
      <address>
        <city>New Braunfels</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 5</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site 24</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <results_first_submitted>June 26, 2019</results_first_submitted>
  <results_first_submitted_qc>June 26, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 17, 2019</results_first_posted>
  <last_update_submitted>July 18, 2019</last_update_submitted>
  <last_update_submitted_qc>July 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2019</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>Rosacea</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azelaic acid</mesh_term>
    <mesh_term>Sunscreening Agents</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>March 28, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT03287791/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>April 6, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT03287791/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The populations for this study included the Safety Population, the modified Intent-to-Treat (mITT) population, and the Per-Protocol (PP) Population.</recruitment_details>
      <pre_assignment_details>If participant failed to return diary card and had no evidence of study drug use, then •participant was included in Safety population if there was some participant safety or efficacy data after Baseline •participant considered lost to follow up and excluded from Safety Population if there was no participant safety or efficacy data after Baseline</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Generic Azelaic Acid Foam</title>
          <description>A thin layer of generic azelaic acid, 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks (wks). Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.</description>
        </group>
        <group group_id="P2">
          <title>Finacea (Azelaic Acid) Foam</title>
          <description>A thin layer of Finacea (azelaic acid), 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.</description>
        </group>
        <group group_id="P3">
          <title>Vehicle Foam</title>
          <description>A thin layer of the vehicle topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="312"/>
                <participants group_id="P2" count="312"/>
                <participants group_id="P3" count="300"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="306"/>
                <participants group_id="P2" count="297"/>
                <participants group_id="P3" count="291"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>mITT Population</title>
              <participants_list>
                <participants group_id="P1" count="291"/>
                <participants group_id="P2" count="291"/>
                <participants group_id="P3" count="283"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>PP Population</title>
              <participants_list>
                <participants group_id="P1" count="262"/>
                <participants group_id="P2" count="259"/>
                <participants group_id="P3" count="245"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="280"/>
                <participants group_id="P2" count="276"/>
                <participants group_id="P3" count="264"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="36"/>
                <participants group_id="P3" count="36"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Insufficient Therapeutic Response</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="17"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missed more than 6 consecutive doses</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant was enrolled at 2 sites</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Too much time between 2 visits</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did not meet inclusion criteria</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Randomized participants with evidence in diary card of using ≥1 dose of study drug (Safety Population).</population>
      <group_list>
        <group group_id="B1">
          <title>Generic Azelaic Acid Foam</title>
          <description>A thin layer of generic azelaic acid, 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.</description>
        </group>
        <group group_id="B2">
          <title>Finacea (Azelaic Acid) Foam</title>
          <description>A thin layer of Finacea (azelaic acid), 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.</description>
        </group>
        <group group_id="B3">
          <title>Vehicle Foam</title>
          <description>A thin layer of the vehicle topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="306"/>
            <count group_id="B2" value="297"/>
            <count group_id="B3" value="291"/>
            <count group_id="B4" value="894"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.6" spread="14.20"/>
                    <measurement group_id="B2" value="52.3" spread="15.14"/>
                    <measurement group_id="B3" value="51.0" spread="15.09"/>
                    <measurement group_id="B4" value="51.6" spread="14.80"/>
                  </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="212"/>
                    <measurement group_id="B2" value="220"/>
                    <measurement group_id="B3" value="204"/>
                    <measurement group_id="B4" value="636"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                    <measurement group_id="B2" value="77"/>
                    <measurement group_id="B3" value="87"/>
                    <measurement group_id="B4" value="258"/>
                  </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="185"/>
                    <measurement group_id="B2" value="177"/>
                    <measurement group_id="B3" value="180"/>
                    <measurement group_id="B4" value="542"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="121"/>
                    <measurement group_id="B2" value="120"/>
                    <measurement group_id="B3" value="111"/>
                    <measurement group_id="B4" value="352"/>
                  </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 group_id="B4" 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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="302"/>
                    <measurement group_id="B2" value="292"/>
                    <measurement group_id="B3" value="288"/>
                    <measurement group_id="B4" value="882"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Inflammatory Lesion Count</title>
          <description>All facial papules and pustules were considered inflammatory lesions. Papule defined as inflammatory lesion; small (≤5 millimeters [mm] in diameter), solid palpable lesion, usually with inflamed elevation of the skin that does not contain pus. Pustule defined as inflammatory lesion; small (≤5 mm in diameter), inflamed skin swelling that is filled with pus.</description>
          <units>inflammatory lesions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17.1" spread="8.85"/>
                    <measurement group_id="B2" value="16.7" spread="7.88"/>
                    <measurement group_id="B3" value="17.7" spread="8.88"/>
                    <measurement group_id="B4" value="17.1" spread="8.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in the Inflammatory Lesions (Papules and Pustules) Counts at Week 12</title>
        <description>All facial papules, pustules, and nodules, located above the jaw line and extending to the hairline, were counted. When counting facial lesions, lesions present on the nose were included. The total count for each lesion type was recorded and the total number of inflammatory lesions (papules and pustules) were calculated. A papule with a pustule on its apex was counted as a pustule. Counts of nodules and cysts were reported separately and not included in the inflammatory counts. Papule defined as inflammatory lesion; small (≤5 mm in diameter), solid palpable lesion, usually with inflamed elevation of the skin that does not contain pus. Pustule defined as inflammatory lesion; small (≤5 mm in diameter), inflamed skin swelling that is filled with pus. Cyst and nodule defined as palpable solid or soft lesion &gt;5 mm in diameter.</description>
        <time_frame>Baseline, 12 weeks</time_frame>
        <population>Participants in the PP Population. If participant discontinued between 8 and 12 weeks of treatment due to lack of treatment, last observation carried forward (LOCF) was used to impute the number of lesions. If participant was missing Week 12 assessment for any other reason, participant was excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Generic Azelaic Acid Foam</title>
            <description>A thin layer of generic azelaic acid, 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.</description>
          </group>
          <group group_id="O2">
            <title>Finacea (Azelaic Acid) Foam</title>
            <description>A thin layer of Finacea (azelaic acid), 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.</description>
          </group>
          <group group_id="O3">
            <title>Vehicle Foam</title>
            <description>A thin layer of the vehicle topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in the Inflammatory Lesions (Papules and Pustules) Counts at Week 12</title>
          <description>All facial papules, pustules, and nodules, located above the jaw line and extending to the hairline, were counted. When counting facial lesions, lesions present on the nose were included. The total count for each lesion type was recorded and the total number of inflammatory lesions (papules and pustules) were calculated. A papule with a pustule on its apex was counted as a pustule. Counts of nodules and cysts were reported separately and not included in the inflammatory counts. Papule defined as inflammatory lesion; small (≤5 mm in diameter), solid palpable lesion, usually with inflamed elevation of the skin that does not contain pus. Pustule defined as inflammatory lesion; small (≤5 mm in diameter), inflamed skin swelling that is filled with pus. Cyst and nodule defined as palpable solid or soft lesion &gt;5 mm in diameter.</description>
          <population>Participants in the PP Population. If participant discontinued between 8 and 12 weeks of treatment due to lack of treatment, last observation carried forward (LOCF) was used to impute the number of lesions. If participant was missing Week 12 assessment for any other reason, participant was excluded.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="262"/>
                <count group_id="O2" value="259"/>
                <count group_id="O3" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-64.28" spread="25.050"/>
                    <measurement group_id="O2" value="-65.15" spread="26.419"/>
                    <measurement group_id="O3" value="-57.84" spread="30.626"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analyses was performed using an Analysis of Variance (ANOVA) model with percent change from baseline to Week 12 in the lesion count as outcome and treatment, center and treatment-by-center interaction as factors.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-11.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.80</ci_lower_limit>
            <ci_upper_limit>-5.73</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analyses was performed using an ANOVA model with percent change from baseline to Week 12 in the lesion count as outcome and treatment, center and treatment-by-center interaction as factors.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0007</p_value>
            <method>ANOVA</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-9.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.28</ci_lower_limit>
            <ci_upper_limit>-4.14</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Treatment Success Based on IGE Score</title>
        <description>Treatment success defined as an Investigator's Global Evaluation (IGE) score at Week 12 of 0 (clear) or 1 (almost clear). Any other outcome was considered a failure. Participants who were discontinued prematurely from the study due to lack of treatment effect after at least 8 weeks of compliant treatment were considered as treatment failures. The IGE score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).</description>
        <time_frame>Baseline and 12 Weeks</time_frame>
        <population>Participants in the PP Population. Participants who did not have a valid Week 12 assessment for any other reason were excluded from the PP analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Generic Azelaic Acid Foam</title>
            <description>A thin layer of generic azelaic acid, 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.</description>
          </group>
          <group group_id="O2">
            <title>Finacea (Azelaic Acid) Foam</title>
            <description>A thin layer of Finacea (azelaic acid), 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.</description>
          </group>
          <group group_id="O3">
            <title>Vehicle Foam</title>
            <description>A thin layer of the vehicle topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Treatment Success Based on IGE Score</title>
          <description>Treatment success defined as an Investigator's Global Evaluation (IGE) score at Week 12 of 0 (clear) or 1 (almost clear). Any other outcome was considered a failure. Participants who were discontinued prematurely from the study due to lack of treatment effect after at least 8 weeks of compliant treatment were considered as treatment failures. The IGE score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).</description>
          <population>Participants in the PP Population. Participants who did not have a valid Week 12 assessment for any other reason were excluded from the PP analysis.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="262"/>
                <count group_id="O2" value="259"/>
                <count group_id="O3" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.7"/>
                    <measurement group_id="O2" value="48.3"/>
                    <measurement group_id="O3" value="33.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to Day 84</time_frame>
      <desc>Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).</desc>
      <group_list>
        <group group_id="E1">
          <title>Generic Azelaic Acid Foam</title>
          <description>A thin layer of generic azelaic acid, 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.</description>
        </group>
        <group group_id="E2">
          <title>Finacea (Azelaic Acid) Foam</title>
          <description>A thin layer of Finacea (azelaic acid), 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.</description>
        </group>
        <group group_id="E3">
          <title>Vehicle Foam</title>
          <description>A thin layer of the vehicle topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="297"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="297"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 18.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="129" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="128" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="125" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Dacryostenosis acquired</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Eye swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Oral discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application site acne</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Application site dryness</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="52" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Application site erythema</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="34" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Application site exfoliation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Application site inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Application site irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Application site oedema</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Application site pain</sub_title>
                <counts group_id="E1" subjects_affected="47" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="41" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="28" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Application site pruritus</sub_title>
                <counts group_id="E1" subjects_affected="51" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="43" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="28" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Application site reaction</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="20" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Application site swelling</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Application site vesicles</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Application site folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Application site pustules</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Pertussis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Eye contusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Sunburn</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Tooth fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Biopsy skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Sinus headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Actinic keratosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Rosacea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Skin disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Swelling face</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Cataract operation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Cholecystectomy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="291"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="291"/>
              </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>Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of Multicenter data.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director, CE Studies</name_or_title>
      <organization>Teva Pharmaceuticals Inc. USA</organization>
      <phone>1-888-483-8279</phone>
      <email>USMedInfo@tevapharm.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/NCT03287791
org study id: ACTA/AZEL/2015
nct id: NCT03287791
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The objectives of this study were to compare the safety and efficacy profiles of a generic
      Azelaic Acid Foam, 15% to the reference listed Finacea® (azelaic acid) Foam, 15% and to
      demonstrate therapeutic equivalence and safety of the two active foams in the treatment of
      moderate facial rosacea, and to demonstrate superiority of the Reference and Test products
      over the Vehicle.
Topical azelaic acid is used to treat inflammatory papules and pustules of mild to moderate
      rosacea. Other topical therapies and oral antibiotics are also used to treat rosacea
      symptoms. Finacea® (azelaic acid) Foam, 15% contains azelaic acid, a naturally occurring
      saturated dicarboxylic acid that has proven anti-inflammatory effects, as well as
      anti-keratinizing and antimicrobial actions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percent Change From Baseline in the Inflammatory Lesions (Papules and Pustules) Counts at Week 12
time frame: Baseline, 12 weeks
description: All facial papules, pustules, and nodules, located above the jaw line and extending to the hairline, were counted. When counting facial lesions, lesions present on the nose were included. The total count for each lesion type was recorded and the total number of inflammatory lesions (papules and pustules) were calculated. A papule with a pustule on its apex was counted as a pustule. Counts of nodules and cysts were reported separately and not included in the inflammatory counts. Papule defined as inflammatory lesion; small (≤5 mm in diameter), solid palpable lesion, usually with inflamed elevation of the skin that does not contain pus. Pustule defined as inflammatory lesion; small (≤5 mm in diameter), inflamed skin swelling that is filled with pus. Cyst and nodule defined as palpable solid or soft lesion >5 mm in diameter.
measure: Percentage of Participants With Treatment Success Based on IGE Score
time frame: Baseline and 12 Weeks
description: Treatment success defined as an Investigator's Global Evaluation (IGE) score at Week 12 of 0 (clear) or 1 (almost clear). Any other outcome was considered a failure. Participants who were discontinued prematurely from the study due to lack of treatment effect after at least 8 weeks of compliant treatment were considered as treatment failures. The IGE score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).
arm group label: Generic Azelaic Acid Foam
arm group type: Experimental
description: A thin layer of generic azelaic acid, 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
arm group label: Finacea® (Azelaic Acid) Foam
arm group type: Active Comparator
description: A thin layer of Finacea (azelaic acid), 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
arm group label: Vehicle Foam
arm group type: Placebo Comparator
description: A thin layer of the vehicle topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
intervention type: Drug
intervention name: Generic Azelaic Acid Foam
description: Topical foam, generic formulation of the brand product.
arm group label: Generic Azelaic Acid Foam
intervention type: Drug
intervention name: Finacea® (Azelaic Acid) Foam
description: Topical foam, brand product.
arm group label: Finacea® (Azelaic Acid) Foam
intervention type: Drug
intervention name: Vehicle Foam
description: Topical foam, placebo. Has no active ingredient.
arm group label: Vehicle Foam
intervention type: Other
intervention name: Cleanser
description: A mild cleanser provided to participants, so they can wash their face prior to applying the study drug.
arm group label: Finacea® (Azelaic Acid) Foam
arm group label: Generic Azelaic Acid Foam
arm group label: Vehicle Foam
intervention type: Other
intervention name: Sunscreen
description: Sunscreen provided to participants, so they can apply it to their face when outdoors.
arm group label: Finacea® (Azelaic Acid) Foam
arm group label: Generic Azelaic Acid Foam
arm group label: Vehicle Foam
intervention type: Other
intervention name: Towel
description: A soft towel provided to participants, so they can pat their face dry after washing and prior to applying the study drug.
arm group label: Finacea® (Azelaic Acid) Foam
arm group label: Generic Azelaic Acid Foam
arm group label: Vehicle Foam
intervention type: Other
intervention name: Moisturizing Lotion
description: Moisturizing lotion provided to participants, so they can apply it to their face, as needed.
arm group label: Finacea® (Azelaic Acid) Foam
arm group label: Generic Azelaic Acid Foam
arm group label: Vehicle Foam
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: Teva Pharmaceuticals USA
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Rosacea
mesh term: Azelaic acid
mesh term: Sunscreening Agents
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 