<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/NCT03824912</url>
  </required_header>
  <id_info>
    <org_study_id>71875502</org_study_id>
    <nct_id>NCT03824912</nct_id>
  </id_info>
  <brief_title>Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the Treatment of Tinea Pedis</brief_title>
  <official_title>A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd) to Ketoconazole Cream 2% (G&amp;W Laboratories Inc.) in the Treatment of Tinea Pedis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Encube Ethicals Pvt. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novum Pharmaceutical Research Services</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>ACM Global Laboratories</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Encube Ethicals Pvt. Ltd.</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the&#xD;
      Treatment of Tinea Pedis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site Clinical Study&#xD;
      to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd) to&#xD;
      Ketoconazole Cream 2% (G&amp;W Laboratories Inc.) in the Treatment of Tinea Pedis&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 23, 2018</start_date>
  <completion_date type="Actual">January 24, 2019</completion_date>
  <primary_completion_date type="Actual">January 24, 2019</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>
    <intervention_model_description>Randomized, double-blind, placebo-controlled, three-arm, parallel group, multiple-site bioequivalence study with clinical endpoints.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>All study products are blinded and provided to the patients in the same packaging.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Equivalence: Per-Protocol Population)</measure>
    <time_frame>Two weeks after the end of treatment (Day 56 ± 4) (Equivalence)</time_frame>
    <description>Equivalence: Per-Protocol Population Therapeutic Cure: To be considered a Therapeutic Cure, the patient must have both Clinical and Mycological Cure of tinea pedis.&#xD;
Therapeutic Failure: A patient will be considered a Therapeutic Failure if:&#xD;
the patient is a Clinical or Mycological Failure&#xD;
the patient was considered to have an insufficient therapeutic response&#xD;
the patient used topical drug therapy for irritation or pruritus on the feet after the treatment phase of the study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population)</measure>
    <time_frame>Two weeks after the end of treatment (Day 56 ± 4) (Superiority)</time_frame>
    <description>Superiority: modified Intent-to-Treat Population Therapeutic Cure: To be considered a Therapeutic Cure, the patient must have both Clinical and Mycological Cure of tinea pedis.&#xD;
Therapeutic Failure: A patient will be considered a Therapeutic Failure if:&#xD;
the patient is a Clinical or Mycological Failure&#xD;
the patient was considered to have an insufficient therapeutic response&#xD;
the patient used topical drug therapy for irritation or pruritus on the feet after the treatment phase of the study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Equivalence: Per-Protocol Population)</measure>
    <time_frame>Two weeks after the end of treatment (Day 56 ± 4) (Equivalence)</time_frame>
    <description>Clinical Cure: To be considered a clinical cure the patient's total severity score must be ≤ 2 with no individual severity score &gt; 1.&#xD;
Clinical Failure: A patient will be considered a Clinical Failure if the patient's total severity score is &gt; 2 or any individual score is &gt; 1.&#xD;
Local Signs and Symptoms The most severely affected area will be identified as the target lesion at the baseline visit and will be used for the assessments at Day 42 and Day 56 visits.&#xD;
The Clinical Signs and Symptoms of tinea pedis will be rated by the Investigator as &quot;none&quot;, &quot;mild,&quot; &quot;moderate&quot; or &quot;severe&quot; using the following standardized rating scale.&#xD;
0 = None (complete absence of any sign or symptom)&#xD;
= Mild (Slight)&#xD;
= Moderate (Definitely Present)&#xD;
= Severe (Marked, Intense)&#xD;
The following signs and symptoms will be rated at each visit:&#xD;
Signs: Fissuring/cracking, erythema, maceration, and scaling&#xD;
Symptoms: Pruritus and burning/stinging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Equivalence: Per-Protocol Population)</measure>
    <time_frame>Two weeks after the end of treatment (Day 56 ± 4) (Equivalence)</time_frame>
    <description>Mycological Cure: To be considered a mycological cure the patient must have a negative Potassium hydroxide (KOH) test and a negative fungal culture.&#xD;
Mycological Failure: A patient will be considered a Mycological Failure if the patient's KOH test is positive or the patient's fungal culture is positive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population)</measure>
    <time_frame>Two weeks after the end of treatment (Day 56 ± 4) (Superiority)</time_frame>
    <description>Clinical Cure: To be considered a clinical cure the patient's total severity score must be ≤ 2 with no individual severity score &gt; 1.&#xD;
Clinical Failure: A patient will be considered a Clinical Failure if the patient's total severity score is &gt; 2 or any individual score is &gt; 1.&#xD;
Local Signs and Symptoms The most severely affected area will be identified as the target lesion at the baseline visit and will be used for the assessments at Day 42 and Day 56 visits.&#xD;
The Clinical Signs and Symptoms of tinea pedis will be rated by the Investigator as &quot;none&quot;, &quot;mild,&quot; &quot;moderate&quot; or &quot;severe&quot; using the following standardized rating scale.&#xD;
0 = None (complete absence of any sign or symptom)&#xD;
= Mild (Slight)&#xD;
= Moderate (Definitely Present)&#xD;
= Severe (Marked, Intense)&#xD;
The following signs and symptoms will be rated at each visit:&#xD;
Signs: Fissuring/cracking, erythema, maceration, and scaling&#xD;
Symptoms: Pruritus and burning/stinging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population)</measure>
    <time_frame>Two weeks after the end of treatment (Day 56 ± 4) (Superiority)</time_frame>
    <description>Mycological Cure: To be considered a mycological cure the patient must have a negative Potassium hydroxide (KOH) test and a negative fungal culture.&#xD;
Mycological Failure: A patient will be considered a Mycological Failure if the patient's KOH test is positive or the patient's fungal culture is positive.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">831</enrollment>
  <condition>Tinea Pedis</condition>
  <arm_group>
    <arm_group_label>Test: Ketoconazole Cream 2%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reference: Ketoconazole Cream 2%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ketoconazole Cream 2% (G&amp;W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo: Cream (Test vehicle)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Cream (Test vehicle) (Encube Ethicals Pvt Ltd)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketoconazole Cream 2%</intervention_name>
    <description>Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.</description>
    <arm_group_label>Test: Ketoconazole Cream 2%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketoconazole Cream 2% (G&amp;W Laboratories Inc.)</intervention_name>
    <description>Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.</description>
    <arm_group_label>Reference: Ketoconazole Cream 2%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.</description>
    <arm_group_label>Placebo: Cream (Test vehicle)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male or non-pregnant, non-lactating female, ≥ 18 years of age.&#xD;
&#xD;
          2. Signed informed consent form (ICF) that meets all criteria of current Food and Drug&#xD;
             Administration regulations.&#xD;
&#xD;
          3. Female patient of childbearing potential must not be pregnant or lactating at Visit 1&#xD;
             (as confirmed by a negative urine pregnancy test with a sensitivity of less than 50&#xD;
             milli-International unit (mIU/mL) or equivalent units of human chorionic&#xD;
             gonadotropin).&#xD;
&#xD;
          4. Female patient of childbearing potential must agree to the use of a reliable method of&#xD;
             contraception throughout the study (e.g., total abstinence, intrauterine device, a&#xD;
             double-barrier method, oral, transdermal, injected, or implanted non-hormonal or&#xD;
             hormonal contraceptive) throughout the study. A sterile sexual partner is not&#xD;
             considered an adequate form of birth control. If the female is using any estrogen or&#xD;
             oral contraceptive therapy, the same product must have been taken for at least one&#xD;
             month before Visit 1.&#xD;
&#xD;
          5. Have clinical diagnosis of tinea pedis with lesions localized to the interdigital&#xD;
             spaces or predominantly interdigital, but may extend to other areas of the foot (the&#xD;
             non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea&#xD;
             pedis moccasin).&#xD;
&#xD;
          6. The presence of tinea pedis infection provisionally confirmed at baseline by a&#xD;
             positive potassium hydroxide (KOH) wet mount preparation (i.e., skin scrapings from&#xD;
             the target site are placed on a microscope slide with a drop of 10% KOH, and&#xD;
             microscopic examination reveals segmented fungal hyphae).&#xD;
&#xD;
          7. The sum of clinical signs and symptoms scores of the target lesion ≥ 4. See Appendix A&#xD;
             for scoring scale:&#xD;
&#xD;
               1. Signs: Fissuring/cracking, erythema, maceration and scaling&#xD;
&#xD;
               2. Symptoms: pruritus and burning/stinging In addition the target lesion must have a&#xD;
                  minimum score ≥ 2 for erythema and a minimum score ≥ 2 for either pruritus or&#xD;
                  scaling.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Females who are pregnant, lactating or planning to become pregnant during the study&#xD;
             period.&#xD;
&#xD;
          2. History of or current psoriasis, Lichen planus or contact dermatitis involving the&#xD;
             feet within the previous 12 months.&#xD;
&#xD;
          3. History of dermatophyte infections with a lack of response to antifungal therapy&#xD;
             (recurrent tinea pedis [i.e., more than 3 infections in the past 12 months] that were&#xD;
             unresponsive to previous antifungal therapy).&#xD;
&#xD;
          4. History of allergy, hypersensitivity, or intolerance to ketoconazole, other&#xD;
             imidazoles, sulfites or any other component of the study product.&#xD;
&#xD;
          5. Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.&#xD;
&#xD;
          6. Current uncontrolled diabetes.&#xD;
&#xD;
          7. Presence of any other infection of the foot or other disease process that, in the&#xD;
             Investigator's opinion, may interfere with the evaluation of the patient's tinea&#xD;
             pedis.&#xD;
&#xD;
          8. Known history of or current impaired wound healing, presence of peripheral vascular&#xD;
             disease and/or trophic changes of the lower limbs to an extent that, in the opinion of&#xD;
             the Investigator, would make the patient unsuitable for the study or compromise&#xD;
             patient's safety.&#xD;
&#xD;
          9. Significant history or current evidence of chronic infectious disease, system&#xD;
             disorder, organ disorder, immunosuppression (due to disease or therapy, including&#xD;
             history of organ transplant), or other medical condition that, in the Investigator's&#xD;
             opinion, would place the patient at undue risk by participating or compromise the&#xD;
             integrity of the study data.&#xD;
&#xD;
         10. Use of antipruritics, including antihistamines, within 72 hours before Visit 1.&#xD;
&#xD;
         11. Use of topical corticosteroids, topical antibiotics or topical antifungal therapy&#xD;
             (e.g., clotrimazole, econazole, fluconazole) within 2 weeks before Visit 1.&#xD;
&#xD;
         12. Use of systemic (e.g., oral or injectable) antibiotics, systemic antifungal therapy,&#xD;
             or systemic corticosteroids within 30 days before Visit 1. The use of intranasal,&#xD;
             inhaled or ophthalmic corticosteroids for acute or chronic conditions (e.g., allergic&#xD;
             conjunctivitis, asthma/chronic obstructive pulmonary disease maintenance) is&#xD;
             acceptable to the extent that, in the opinion of the Investigator, does not compromise&#xD;
             safety of patient or integrity of data.&#xD;
&#xD;
         13. Use of oral terbinafine or itraconazole within 2 months before Visit 1.&#xD;
&#xD;
         14. Use of immunosuppressive medication or radiation therapy within 3 months before Visit&#xD;
             1.&#xD;
&#xD;
         15. Receipt of any drug as part of a research study within 30 days before Visit 1.&#xD;
&#xD;
         16. Previous participation in this study.&#xD;
&#xD;
         17. Employee of the Investigator or research center or their immediate family members.&#xD;
&#xD;
         18. Inability to understand the requirements of the study and the relative information or&#xD;
             are unable or unwilling to comply with the study protocol.&#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>Lalatendu Panigrahi</last_name>
    <role>Study Director</role>
    <affiliation>Encube Ethicals Pvt. Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Long Beach Clinical Trial Services, Inc.</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Marcus Research Clinic, Inc.</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>International Dermatology Research, Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FXM Research Corp.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33175</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FXM Research Miramar</name>
      <address>
        <city>Miramar</city>
        <state>Florida</state>
        <zip>33027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MOORE Clinical Research, Inc.</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PEAK Research, LLC</name>
      <address>
        <city>Upper Saint Clair</city>
        <state>Pennsylvania</state>
        <zip>15241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FXM Research International</name>
      <address>
        <city>Belize City</city>
        <country>Belize</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FXM Research International</name>
      <address>
        <city>Castries</city>
        <country>Saint Lucia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belize</country>
    <country>Saint Lucia</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <results_first_submitted>April 11, 2019</results_first_submitted>
  <results_first_submitted_qc>May 23, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 13, 2019</results_first_posted>
  <last_update_submitted>June 19, 2019</last_update_submitted>
  <last_update_submitted_qc>June 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 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>Tinea</mesh_term>
    <mesh_term>Tinea Pedis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketoconazole</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <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>February 28, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT03824912/SAP_000.pdf</document_url>
    </provided_document>
    <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>November 8, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT03824912/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Test: Ketoconazole Cream 2%</title>
          <description>Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd)&#xD;
Ketoconazole Cream 2%: Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.</description>
        </group>
        <group group_id="P2">
          <title>Reference: Ketoconazole Cream 2%</title>
          <description>Ketoconazole Cream 2% (G&amp;W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.)&#xD;
Ketoconazole Cream 2% (G&amp;W Laboratories Inc.): Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.</description>
        </group>
        <group group_id="P3">
          <title>Placebo: Cream (Test Vehicle)</title>
          <description>Placebo Cream (Test vehicle) (Encube Ethicals Pvt Ltd)&#xD;
Placebo: Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="332"/>
                <participants group_id="P2" count="335"/>
                <participants group_id="P3" count="164"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="192"/>
                <participants group_id="P2" count="201"/>
                <participants group_id="P3" count="96"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="140"/>
                <participants group_id="P2" count="134"/>
                <participants group_id="P3" count="68"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Negative Baseline Culture Result</title>
              <participants_list>
                <participants group_id="P1" count="118"/>
                <participants group_id="P2" count="112"/>
                <participants group_id="P3" count="57"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-Compliance with Study Drug</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>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participation in another study</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_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Safety population was used for the baseline analysis population. The Safety population included all randomized patients who used at least one dose of product.</population>
      <group_list>
        <group group_id="B1">
          <title>Test: Ketoconazole Cream 2%</title>
          <description>Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd)&#xD;
Ketoconazole Cream 2%: Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.</description>
        </group>
        <group group_id="B2">
          <title>Reference: Ketoconazole Cream 2%</title>
          <description>Ketoconazole Cream 2% (G&amp;W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.)&#xD;
Ketoconazole Cream 2% (G&amp;W Laboratories Inc.): Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.</description>
        </group>
        <group group_id="B3">
          <title>Placebo: Cream (Test Vehicle)</title>
          <description>Placebo Cream (Test vehicle) (Encube Ethicals Pvt Ltd)&#xD;
Placebo: Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.</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="314"/>
            <count group_id="B2" value="319"/>
            <count group_id="B3" value="156"/>
            <count group_id="B4" value="789"/>
          </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="45.6" spread="13.6"/>
                    <measurement group_id="B2" value="46.7" spread="13.9"/>
                    <measurement group_id="B3" value="44.8" spread="14.4"/>
                    <measurement group_id="B4" value="45.9" spread="13.9"/>
                  </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="131"/>
                    <measurement group_id="B2" value="114"/>
                    <measurement group_id="B3" value="64"/>
                    <measurement group_id="B4" value="309"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="183"/>
                    <measurement group_id="B2" value="205"/>
                    <measurement group_id="B3" value="92"/>
                    <measurement group_id="B4" value="480"/>
                  </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="154"/>
                    <measurement group_id="B2" value="153"/>
                    <measurement group_id="B3" value="75"/>
                    <measurement group_id="B4" value="382"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="160"/>
                    <measurement group_id="B2" value="166"/>
                    <measurement group_id="B3" value="81"/>
                    <measurement group_id="B4" value="407"/>
                  </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="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</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>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="147"/>
                    <measurement group_id="B2" value="153"/>
                    <measurement group_id="B3" value="74"/>
                    <measurement group_id="B4" value="374"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="166"/>
                    <measurement group_id="B2" value="163"/>
                    <measurement group_id="B3" value="80"/>
                    <measurement group_id="B4" value="409"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="5"/>
                  </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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Equivalence: Per-Protocol Population)</title>
        <description>Equivalence: Per-Protocol Population Therapeutic Cure: To be considered a Therapeutic Cure, the patient must have both Clinical and Mycological Cure of tinea pedis.&#xD;
Therapeutic Failure: A patient will be considered a Therapeutic Failure if:&#xD;
the patient is a Clinical or Mycological Failure&#xD;
the patient was considered to have an insufficient therapeutic response&#xD;
the patient used topical drug therapy for irritation or pruritus on the feet after the treatment phase of the study</description>
        <time_frame>Two weeks after the end of treatment (Day 56 ± 4) (Equivalence)</time_frame>
        <population>The Per-Protocol population was used for this analysis to determine equivalence between the Test and Reference groups only. To determine equivalence, only the test and reference treatment arms are analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Test: Ketoconazole Cream 2%</title>
            <description>Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd)&#xD;
Ketoconazole Cream 2%: Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.</description>
          </group>
          <group group_id="O2">
            <title>Reference: Ketoconazole Cream 2%</title>
            <description>Ketoconazole Cream 2% (G&amp;W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.)&#xD;
Ketoconazole Cream 2% (G&amp;W Laboratories Inc.): Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Equivalence: Per-Protocol Population)</title>
          <description>Equivalence: Per-Protocol Population Therapeutic Cure: To be considered a Therapeutic Cure, the patient must have both Clinical and Mycological Cure of tinea pedis.&#xD;
Therapeutic Failure: A patient will be considered a Therapeutic Failure if:&#xD;
the patient is a Clinical or Mycological Failure&#xD;
the patient was considered to have an insufficient therapeutic response&#xD;
the patient used topical drug therapy for irritation or pruritus on the feet after the treatment phase of the study</description>
          <population>The Per-Protocol population was used for this analysis to determine equivalence between the Test and Reference groups only. To determine equivalence, only the test and reference treatment arms are analyzed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="184"/>
                <count group_id="O2" value="191"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                    <measurement group_id="O2" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population)</title>
        <description>Superiority: modified Intent-to-Treat Population Therapeutic Cure: To be considered a Therapeutic Cure, the patient must have both Clinical and Mycological Cure of tinea pedis.&#xD;
Therapeutic Failure: A patient will be considered a Therapeutic Failure if:&#xD;
the patient is a Clinical or Mycological Failure&#xD;
the patient was considered to have an insufficient therapeutic response&#xD;
the patient used topical drug therapy for irritation or pruritus on the feet after the treatment phase of the study</description>
        <time_frame>Two weeks after the end of treatment (Day 56 ± 4) (Superiority)</time_frame>
        <population>The MITT Population was used for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Test: Ketoconazole Cream 2%</title>
            <description>Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd)&#xD;
Ketoconazole Cream 2%: Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.</description>
          </group>
          <group group_id="O2">
            <title>Reference: Ketoconazole Cream 2%</title>
            <description>Ketoconazole Cream 2% (G&amp;W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.)&#xD;
Ketoconazole Cream 2% (G&amp;W Laboratories Inc.): Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.</description>
          </group>
          <group group_id="O3">
            <title>Placebo: Cream (Test Vehicle)</title>
            <description>Placebo Cream (Test vehicle) (Encube Ethicals Pvt Ltd)&#xD;
Placebo: Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population)</title>
          <description>Superiority: modified Intent-to-Treat Population Therapeutic Cure: To be considered a Therapeutic Cure, the patient must have both Clinical and Mycological Cure of tinea pedis.&#xD;
Therapeutic Failure: A patient will be considered a Therapeutic Failure if:&#xD;
the patient is a Clinical or Mycological Failure&#xD;
the patient was considered to have an insufficient therapeutic response&#xD;
the patient used topical drug therapy for irritation or pruritus on the feet after the treatment phase of the study</description>
          <population>The MITT Population was used for analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="195"/>
                <count group_id="O2" value="199"/>
                <count group_id="O3" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92"/>
                    <measurement group_id="O2" value="94"/>
                    <measurement group_id="O3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Equivalence: Per-Protocol Population)</title>
        <description>Clinical Cure: To be considered a clinical cure the patient's total severity score must be ≤ 2 with no individual severity score &gt; 1.&#xD;
Clinical Failure: A patient will be considered a Clinical Failure if the patient's total severity score is &gt; 2 or any individual score is &gt; 1.&#xD;
Local Signs and Symptoms The most severely affected area will be identified as the target lesion at the baseline visit and will be used for the assessments at Day 42 and Day 56 visits.&#xD;
The Clinical Signs and Symptoms of tinea pedis will be rated by the Investigator as &quot;none&quot;, &quot;mild,&quot; &quot;moderate&quot; or &quot;severe&quot; using the following standardized rating scale.&#xD;
0 = None (complete absence of any sign or symptom)&#xD;
= Mild (Slight)&#xD;
= Moderate (Definitely Present)&#xD;
= Severe (Marked, Intense)&#xD;
The following signs and symptoms will be rated at each visit:&#xD;
Signs: Fissuring/cracking, erythema, maceration, and scaling&#xD;
Symptoms: Pruritus and burning/stinging</description>
        <time_frame>Two weeks after the end of treatment (Day 56 ± 4) (Equivalence)</time_frame>
        <population>The Per-Protocol population was used for this analysis to determine equivalence between the Test and Reference groups only. To determine equivalence, only the test and reference treatment arms are analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Test: Ketoconazole Cream 2%</title>
            <description>Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd)&#xD;
Ketoconazole Cream 2%: Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.</description>
          </group>
          <group group_id="O2">
            <title>Reference: Ketoconazole Cream 2%</title>
            <description>Ketoconazole Cream 2% (G&amp;W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.)&#xD;
Ketoconazole Cream 2% (G&amp;W Laboratories Inc.): Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Equivalence: Per-Protocol Population)</title>
          <description>Clinical Cure: To be considered a clinical cure the patient's total severity score must be ≤ 2 with no individual severity score &gt; 1.&#xD;
Clinical Failure: A patient will be considered a Clinical Failure if the patient's total severity score is &gt; 2 or any individual score is &gt; 1.&#xD;
Local Signs and Symptoms The most severely affected area will be identified as the target lesion at the baseline visit and will be used for the assessments at Day 42 and Day 56 visits.&#xD;
The Clinical Signs and Symptoms of tinea pedis will be rated by the Investigator as &quot;none&quot;, &quot;mild,&quot; &quot;moderate&quot; or &quot;severe&quot; using the following standardized rating scale.&#xD;
0 = None (complete absence of any sign or symptom)&#xD;
= Mild (Slight)&#xD;
= Moderate (Definitely Present)&#xD;
= Severe (Marked, Intense)&#xD;
The following signs and symptoms will be rated at each visit:&#xD;
Signs: Fissuring/cracking, erythema, maceration, and scaling&#xD;
Symptoms: Pruritus and burning/stinging</description>
          <population>The Per-Protocol population was used for this analysis to determine equivalence between the Test and Reference groups only. To determine equivalence, only the test and reference treatment arms are analyzed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="184"/>
                <count group_id="O2" value="191"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97"/>
                    <measurement group_id="O2" value="110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Equivalence: Per-Protocol Population)</title>
        <description>Mycological Cure: To be considered a mycological cure the patient must have a negative Potassium hydroxide (KOH) test and a negative fungal culture.&#xD;
Mycological Failure: A patient will be considered a Mycological Failure if the patient's KOH test is positive or the patient's fungal culture is positive.</description>
        <time_frame>Two weeks after the end of treatment (Day 56 ± 4) (Equivalence)</time_frame>
        <population>The PP population was used for this analysis to determine equivalence between the Test and Reference groups only. One patient had an inconclusive result for the fungal culture at Visit 3 and was excluded from the analysis of the secondary endpoint for the mycological cure. Patient was a clinical failure and was included in the primary analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Test: Ketoconazole Cream 2%</title>
            <description>Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd)&#xD;
Ketoconazole Cream 2%: Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.</description>
          </group>
          <group group_id="O2">
            <title>Reference: Ketoconazole Cream 2%</title>
            <description>Ketoconazole Cream 2% (G&amp;W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.)&#xD;
Ketoconazole Cream 2% (G&amp;W Laboratories Inc.): Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Equivalence: Per-Protocol Population)</title>
          <description>Mycological Cure: To be considered a mycological cure the patient must have a negative Potassium hydroxide (KOH) test and a negative fungal culture.&#xD;
Mycological Failure: A patient will be considered a Mycological Failure if the patient's KOH test is positive or the patient's fungal culture is positive.</description>
          <population>The PP population was used for this analysis to determine equivalence between the Test and Reference groups only. One patient had an inconclusive result for the fungal culture at Visit 3 and was excluded from the analysis of the secondary endpoint for the mycological cure. Patient was a clinical failure and was included in the primary analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="184"/>
                <count group_id="O2" value="190"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127"/>
                    <measurement group_id="O2" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population)</title>
        <description>Clinical Cure: To be considered a clinical cure the patient's total severity score must be ≤ 2 with no individual severity score &gt; 1.&#xD;
Clinical Failure: A patient will be considered a Clinical Failure if the patient's total severity score is &gt; 2 or any individual score is &gt; 1.&#xD;
Local Signs and Symptoms The most severely affected area will be identified as the target lesion at the baseline visit and will be used for the assessments at Day 42 and Day 56 visits.&#xD;
The Clinical Signs and Symptoms of tinea pedis will be rated by the Investigator as &quot;none&quot;, &quot;mild,&quot; &quot;moderate&quot; or &quot;severe&quot; using the following standardized rating scale.&#xD;
0 = None (complete absence of any sign or symptom)&#xD;
= Mild (Slight)&#xD;
= Moderate (Definitely Present)&#xD;
= Severe (Marked, Intense)&#xD;
The following signs and symptoms will be rated at each visit:&#xD;
Signs: Fissuring/cracking, erythema, maceration, and scaling&#xD;
Symptoms: Pruritus and burning/stinging</description>
        <time_frame>Two weeks after the end of treatment (Day 56 ± 4) (Superiority)</time_frame>
        <population>The MITT population was used for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Test: Ketoconazole Cream 2%</title>
            <description>Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd)&#xD;
Ketoconazole Cream 2%: Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.</description>
          </group>
          <group group_id="O2">
            <title>Reference: Ketoconazole Cream 2%</title>
            <description>Ketoconazole Cream 2% (G&amp;W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.)&#xD;
Ketoconazole Cream 2% (G&amp;W Laboratories Inc.): Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.</description>
          </group>
          <group group_id="O3">
            <title>Placebo: Cream (Test Vehicle)</title>
            <description>Placebo Cream (Test vehicle) (Encube Ethicals Pvt Ltd)&#xD;
Placebo: Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population)</title>
          <description>Clinical Cure: To be considered a clinical cure the patient's total severity score must be ≤ 2 with no individual severity score &gt; 1.&#xD;
Clinical Failure: A patient will be considered a Clinical Failure if the patient's total severity score is &gt; 2 or any individual score is &gt; 1.&#xD;
Local Signs and Symptoms The most severely affected area will be identified as the target lesion at the baseline visit and will be used for the assessments at Day 42 and Day 56 visits.&#xD;
The Clinical Signs and Symptoms of tinea pedis will be rated by the Investigator as &quot;none&quot;, &quot;mild,&quot; &quot;moderate&quot; or &quot;severe&quot; using the following standardized rating scale.&#xD;
0 = None (complete absence of any sign or symptom)&#xD;
= Mild (Slight)&#xD;
= Moderate (Definitely Present)&#xD;
= Severe (Marked, Intense)&#xD;
The following signs and symptoms will be rated at each visit:&#xD;
Signs: Fissuring/cracking, erythema, maceration, and scaling&#xD;
Symptoms: Pruritus and burning/stinging</description>
          <population>The MITT population was used for analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="195"/>
                <count group_id="O2" value="199"/>
                <count group_id="O3" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="116"/>
                    <measurement group_id="O3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population)</title>
        <description>Mycological Cure: To be considered a mycological cure the patient must have a negative Potassium hydroxide (KOH) test and a negative fungal culture.&#xD;
Mycological Failure: A patient will be considered a Mycological Failure if the patient's KOH test is positive or the patient's fungal culture is positive.</description>
        <time_frame>Two weeks after the end of treatment (Day 56 ± 4) (Superiority)</time_frame>
        <population>The MITT population was used for the analysis. One patient had an inconclusive result for the fungal culture at Visit 3 and was excluded from the analysis of the secondary endpoint for the mycological cure. Patient was a clinical failure and was included in the primary analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Test: Ketoconazole Cream 2%</title>
            <description>Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd)&#xD;
Ketoconazole Cream 2%: Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.</description>
          </group>
          <group group_id="O2">
            <title>Reference: Ketoconazole Cream 2%</title>
            <description>Ketoconazole Cream 2% (G&amp;W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.)&#xD;
Ketoconazole Cream 2% (G&amp;W Laboratories Inc.): Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.</description>
          </group>
          <group group_id="O3">
            <title>Placebo: Cream (Test Vehicle)</title>
            <description>Placebo Cream (Test vehicle) (Encube Ethicals Pvt Ltd)&#xD;
Placebo: Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population)</title>
          <description>Mycological Cure: To be considered a mycological cure the patient must have a negative Potassium hydroxide (KOH) test and a negative fungal culture.&#xD;
Mycological Failure: A patient will be considered a Mycological Failure if the patient's KOH test is positive or the patient's fungal culture is positive.</description>
          <population>The MITT population was used for the analysis. One patient had an inconclusive result for the fungal culture at Visit 3 and was excluded from the analysis of the secondary endpoint for the mycological cure. Patient was a clinical failure and was included in the primary analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="195"/>
                <count group_id="O2" value="198"/>
                <count group_id="O3" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="132"/>
                    <measurement group_id="O2" value="122"/>
                    <measurement group_id="O3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>5 months</time_frame>
      <desc>The &quot;Total Number of Participants at Risk&quot; is not consistent with the numbers provided in any of the rows in the Participant Flow module, since the Overall Summary of Adverse Events is based on the Safety Population.&#xD;
The Safety population will include all randomized patients who use at least one dose of product.</desc>
      <group_list>
        <group group_id="E1">
          <title>Test: Ketoconazole Cream 2%</title>
          <description>Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd)&#xD;
Ketoconazole Cream 2%: Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.</description>
        </group>
        <group group_id="E2">
          <title>Reference: Ketoconazole Cream 2%</title>
          <description>Ketoconazole Cream 2% (G&amp;W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.)&#xD;
Ketoconazole Cream 2% (G&amp;W Laboratories Inc.): Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.</description>
        </group>
        <group group_id="E3">
          <title>Placebo: Cream (Test Vehicle)</title>
          <description>Placebo Cream (Test vehicle) (Encube Ethicals Pvt Ltd)&#xD;
Placebo: Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="319"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="319"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 21.1</default_vocab>
        <default_assessment>Non-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="12" subjects_at_risk="314"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="319"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="156"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="319"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="319"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="319"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="156"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="319"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="156"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="314"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="319"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="156"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="319"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
              </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" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="319"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="319"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="319"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="156"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="319"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="156"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="319"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="319"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="156"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="319"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="319"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="314"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="319"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Adnexa uteri pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="319"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="156"/>
              </event>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="319"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="319"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="156"/>
              </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>In the Clinical Trials Agreements between the sites and the Contract Research Organization, sites are instructed that the Investigator shall not publish, or seek to publish, either in whole or in part any results of the Study without the written consent.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Lalatendu Panigrahi, Chief Scientific Officer</name_or_title>
      <organization>Encube Ethicals Pvt Ltd</organization>
      <phone>+91-22-6264-7002</phone>
      <email>lalatendu.p@encubeethicals.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/NCT03824912
org study id: 71875502
nct id: NCT03824912
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the
      Treatment of Tinea Pedis
A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site Clinical Study
      to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd) to
      Ketoconazole Cream 2% (G&W Laboratories Inc.) in the Treatment of Tinea Pedis
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, double-blind, placebo-controlled, three-arm, parallel group, multiple-site bioequivalence study with clinical endpoints.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: All study products are blinded and provided to the patients in the same packaging.
measure: Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Equivalence: Per-Protocol Population)
time frame: Two weeks after the end of treatment (Day 56 ± 4) (Equivalence)
description: Equivalence: Per-Protocol Population Therapeutic Cure: To be considered a Therapeutic Cure, the patient must have both Clinical and Mycological Cure of tinea pedis.
Therapeutic Failure: A patient will be considered a Therapeutic Failure if:
the patient is a Clinical or Mycological Failure
the patient was considered to have an insufficient therapeutic response
the patient used topical drug therapy for irritation or pruritus on the feet after the treatment phase of the study
measure: Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population)
time frame: Two weeks after the end of treatment (Day 56 ± 4) (Superiority)
description: Superiority: modified Intent-to-Treat Population Therapeutic Cure: To be considered a Therapeutic Cure, the patient must have both Clinical and Mycological Cure of tinea pedis.
Therapeutic Failure: A patient will be considered a Therapeutic Failure if:
the patient is a Clinical or Mycological Failure
the patient was considered to have an insufficient therapeutic response
the patient used topical drug therapy for irritation or pruritus on the feet after the treatment phase of the study
measure: Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Equivalence: Per-Protocol Population)
time frame: Two weeks after the end of treatment (Day 56 ± 4) (Equivalence)
description: Clinical Cure: To be considered a clinical cure the patient's total severity score must be ≤ 2 with no individual severity score > 1.
Clinical Failure: A patient will be considered a Clinical Failure if the patient's total severity score is > 2 or any individual score is > 1.
Local Signs and Symptoms The most severely affected area will be identified as the target lesion at the baseline visit and will be used for the assessments at Day 42 and Day 56 visits.
The Clinical Signs and Symptoms of tinea pedis will be rated by the Investigator as "none", "mild," "moderate" or "severe" using the following standardized rating scale.
0 = None (complete absence of any sign or symptom)
= Mild (Slight)
= Moderate (Definitely Present)
= Severe (Marked, Intense)
The following signs and symptoms will be rated at each visit:
Signs: Fissuring/cracking, erythema, maceration, and scaling
Symptoms: Pruritus and burning/stinging
measure: Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Equivalence: Per-Protocol Population)
time frame: Two weeks after the end of treatment (Day 56 ± 4) (Equivalence)
description: Mycological Cure: To be considered a mycological cure the patient must have a negative Potassium hydroxide (KOH) test and a negative fungal culture.
Mycological Failure: A patient will be considered a Mycological Failure if the patient's KOH test is positive or the patient's fungal culture is positive.
measure: Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population)
time frame: Two weeks after the end of treatment (Day 56 ± 4) (Superiority)
description: Clinical Cure: To be considered a clinical cure the patient's total severity score must be ≤ 2 with no individual severity score > 1.
Clinical Failure: A patient will be considered a Clinical Failure if the patient's total severity score is > 2 or any individual score is > 1.
Local Signs and Symptoms The most severely affected area will be identified as the target lesion at the baseline visit and will be used for the assessments at Day 42 and Day 56 visits.
The Clinical Signs and Symptoms of tinea pedis will be rated by the Investigator as "none", "mild," "moderate" or "severe" using the following standardized rating scale.
0 = None (complete absence of any sign or symptom)
= Mild (Slight)
= Moderate (Definitely Present)
= Severe (Marked, Intense)
The following signs and symptoms will be rated at each visit:
Signs: Fissuring/cracking, erythema, maceration, and scaling
Symptoms: Pruritus and burning/stinging
measure: Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population)
time frame: Two weeks after the end of treatment (Day 56 ± 4) (Superiority)
description: Mycological Cure: To be considered a mycological cure the patient must have a negative Potassium hydroxide (KOH) test and a negative fungal culture.
Mycological Failure: A patient will be considered a Mycological Failure if the patient's KOH test is positive or the patient's fungal culture is positive.
arm group label: Test: Ketoconazole Cream 2%
arm group type: Experimental
description: Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd)
arm group label: Reference: Ketoconazole Cream 2%
arm group type: Active Comparator
description: Ketoconazole Cream 2% (G&W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.)
arm group label: Placebo: Cream (Test vehicle)
arm group type: Placebo Comparator
description: Placebo Cream (Test vehicle) (Encube Ethicals Pvt Ltd)
intervention type: Drug
intervention name: Ketoconazole Cream 2%
description: Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.
arm group label: Test: Ketoconazole Cream 2%
intervention type: Drug
intervention name: Ketoconazole Cream 2% (G&W Laboratories Inc.)
description: Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.
arm group label: Reference: Ketoconazole Cream 2%
intervention type: Drug
intervention name: Placebo
description: Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.
arm group label: Placebo: Cream (Test vehicle)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lalatendu Panigrahi
role: Study Director
affiliation: Encube Ethicals Pvt. Ltd.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belize
country: Saint Lucia
country: United States
responsible party type: Sponsor
mesh term: Tinea
mesh term: Tinea Pedis
mesh term: Ketoconazole
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 