xml: <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/NCT06000514</url>
    </required_header>
    <id_info>
      <org_study_id>SM29CL.1</org_study_id>
      <nct_id>NCT06000514</nct_id>
    </id_info>
    <brief_title>Topical Sm29 in Combination With Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis.</brief_title>
    <official_title>Association of Topical Sm29 in Gold Nanoparticles With Intravenous Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania Braziliensis: A Randomized Controlled Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospital Universitário Professor Edgard Santos</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Conselho Nacional de Desenvolvimento Científico e Tecnológico</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Oswaldo Cruz Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Hospital Universitário Professor Edgard Santos</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This project is composed of a phase I study with the purpose of evaluating adverse reactions&#xD;
        and the best dose to be used of Sm29 and a phase II randomized controlled study with 3 arms&#xD;
        with the purpose of comparing the efficacy of meglumine antimoniate associated with Sm29,&#xD;
        with meglumine antimoniate plus placebo and meglumine antimoniate alone in the treatment of&#xD;
        cutaneous leishmaniasis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The phase I study was performed in 10 healthy subjects and 10 patients with CL. In healthy&#xD;
        individuals (N=5) Sm29 was applied to healthy skin at a concentration of 5ug and in another 5&#xD;
        Sm29 was used at a dose of 10ug applied twice a day for 20 days. A phase I study was also&#xD;
        carried out in 10 patients with CL to assess the occurrence of adverse reactions to Sm29&#xD;
        applied to the ulcerated lesion and to compare the use of two doses of Sm29. In 5 patients,&#xD;
        Sm29 was used at a dose of 5ug and applied twice a day, and in 10 patients, a dose of 10ug of&#xD;
        Sm29 was used, also applied twice a day. The 10 patients were also treated with glucantime at&#xD;
        a dose of 20mg/kg/weight with a maximum dose of 1200mg/day intravenously for 20 days.&#xD;
        Patients were evaluated on days 10, 20 and 30 for adverse reactions.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 17, 2019</start_date>
    <completion_date type="Actual">July 7, 2022</completion_date>
    <primary_completion_date type="Actual">April 6, 2022</primary_completion_date>
    <phase>Phase 1/Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Randomized and controlled</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>Both arms will use the same active standard medication (Sbv) and both arms will use a topical cream (one arm - placebo; the other Sm29).</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Cure</measure>
      <time_frame>90 days</time_frame>
      <description>Complete re epithelization of the ulcer(s), without any area of ulceration and without raised or infiltrated borders.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">20</enrollment>
    <condition>Cutaneous Leishmaniasis, American</condition>
    <arm_group>
      <arm_group_label>Topical Sm29 and Sbv</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Use of topical Sm29 twice a day during 20 days and systemic Sbv during 20 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Topical Placebo and Sbv</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Use of topical placebo twice a day during 20 days and systemic Sbv during 20 days</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sm29 Protein, Schistosoma Mansoni</intervention_name>
      <description>Sm29 cream twice a day in the ulcer(s), during 20 days; and Systemic IV Pentavalent antimony (Sbv) at 20mg/kg/day during 20 days.</description>
      <arm_group_label>Topical Sm29 and Sbv</arm_group_label>
      <other_name>Pentavalent antimony (Sbv)</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Pentavalent antimony (Sbv)</intervention_name>
      <description>Placebo cream twice a day in the ulcer(s), during 20 days; and Systemic IV Pentavalent antimony (Sbv) at 20mg/kg/day during 20 days.</description>
      <arm_group_label>Topical Placebo and Sbv</arm_group_label>
      <arm_group_label>Topical Sm29 and Sbv</arm_group_label>
      <other_name>Placebo cream</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - Clinical diagnosis of cutaneous leishmaniasis (typical ulcerated lesion); 1 to 2 ulcers;&#xD;
          ulcer size ranging from 10-40mm; disease duration between 20-90 days.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diabetes; Cardiovascular or kidney disease; HIV seropositivity; use of&#xD;
               immunosupressive drugs; pregnancy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>SERGIO C OLIVEIRA, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Federal University of Minas Gerais</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Corte de Pedra Health Post</name>
        <address>
          <city>Presidente Tancredo Neves</city>
          <state>Bahia</state>
          <zip>40000</zip>
          <country>Brazil</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hospital Universitário Professor Edgard Santos</investigator_affiliation>
      <investigator_full_name>Paulo Roberto Lima Machado</investigator_full_name>
      <investigator_title>Head of Immunology Service</investigator_title>
    </responsible_party>
    <keyword>Cutaneous Leishmaniasis</keyword>
    <keyword>Sm29</keyword>
    <keyword>L. braziliensis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Leishmaniasis</mesh_term>
      <mesh_term>Leishmaniasis, Cutaneous</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Not to be shared.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06000514
  org study id: SM29CL.1
  nct id: NCT06000514
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This project is composed of a phase I study with the purpose of evaluating adverse reactions
        and the best dose to be used of Sm29 and a phase II randomized controlled study with 3 arms
        with the purpose of comparing the efficacy of meglumine antimoniate associated with Sm29,
        with meglumine antimoniate plus placebo and meglumine antimoniate alone in the treatment of
        cutaneous leishmaniasis.
  The phase I study was performed in 10 healthy subjects and 10 patients with CL. In healthy
        individuals (N=5) Sm29 was applied to healthy skin at a concentration of 5ug and in another 5
        Sm29 was used at a dose of 10ug applied twice a day for 20 days. A phase I study was also
        carried out in 10 patients with CL to assess the occurrence of adverse reactions to Sm29
        applied to the ulcerated lesion and to compare the use of two doses of Sm29. In 5 patients,
        Sm29 was used at a dose of 5ug and applied twice a day, and in 10 patients, a dose of 10ug of
        Sm29 was used, also applied twice a day. The 10 patients were also treated with glucantime at
        a dose of 20mg/kg/weight with a maximum dose of 1200mg/day intravenously for 20 days.
        Patients were evaluated on days 10, 20 and 30 for adverse reactions.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized and controlled
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: Both arms will use the same active standard medication (Sbv) and both arms will use a topical cream (one arm - placebo; the other Sm29).
  measure: Cure
  time frame: 90 days
  description: Complete re epithelization of the ulcer(s), without any area of ulceration and without raised or infiltrated borders.
  arm group label: Topical Sm29 and Sbv
  arm group type: Experimental
  description: Use of topical Sm29 twice a day during 20 days and systemic Sbv during 20 days
  arm group label: Topical Placebo and Sbv
  arm group type: Placebo Comparator
  description: Use of topical placebo twice a day during 20 days and systemic Sbv during 20 days
  intervention type: Drug
  intervention name: Sm29 Protein, Schistosoma Mansoni
  description: Sm29 cream twice a day in the ulcer(s), during 20 days; and Systemic IV Pentavalent antimony (Sbv) at 20mg/kg/day during 20 days.
  arm group label: Topical Sm29 and Sbv
  other name: Pentavalent antimony (Sbv)
  intervention type: Drug
  intervention name: Pentavalent antimony (Sbv)
  description: Placebo cream twice a day in the ulcer(s), during 20 days; and Systemic IV Pentavalent antimony (Sbv) at 20mg/kg/day during 20 days.
  arm group label: Topical Placebo and Sbv
  arm group label: Topical Sm29 and Sbv
  other name: Placebo cream
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: SERGIO C OLIVEIRA, PhD
  role: Principal Investigator
  affiliation: Federal University of Minas Gerais
  facility: 
  country: Brazil
  responsible party type: Principal Investigator
  investigator affiliation: Hospital Universitário Professor Edgard Santos
  investigator full name: Paulo Roberto Lima Machado
  investigator title: Head of Immunology Service
  mesh term: Leishmaniasis
  mesh term: Leishmaniasis, Cutaneous
  sharing ipd: No
  ipd description: Not to be shared.