<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/NCT04453124</url>
  </required_header>
  <id_info>
    <org_study_id>SAPKOKOPO</org_study_id>
    <nct_id>NCT04453124</nct_id>
  </id_info>
  <brief_title>An Accessible Low-cost Plant Treatment for Cutaneous Ulcers</brief_title>
  <official_title>An Accessible Low-cost Plant Treatment for Cutaneous Ulcers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oriol Mitja</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The University of Papua New Guinea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Royal Botanic Gardens, Kew</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lihir Medical Centre</source>
  <oversight_info>
    <has_dmc>No</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>
      In a search for accessible treatment options, plant medicines used by different communities&#xD;
      in Papua New Guinea have been tested to identify the sap of the tree, Ficus septica, as a&#xD;
      promising antibacterial agent in vitro.&#xD;
&#xD;
      This is an open label clinical trial using an interventional approach, to compare the effect&#xD;
      of the antiseptic plant sap and standard topical antiseptic, on the rate of wound development&#xD;
      prevention and bacterial growth. If shown to be effective, this readily available plant&#xD;
      medicine can provide a zero-cost treatment option in remote areas of PNG.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The cutaneous ulcer is a painful and debilitating bacterial infection that is common in rural&#xD;
      areas of Papua New Guinea (PNG). Systematic treatment with topical antiseptics such as&#xD;
      chlorhexidine cream in theory represents a viable treatment option, but in reality, effective&#xD;
      treatment of cutaneous ulcers in Papua New Guinea is greatly hindered by the remote and&#xD;
      highly inaccessible areas that affected communities often live in. In a search for more&#xD;
      accessible treatment options, plant medicines used by different communities in Papua New&#xD;
      Guinea have been tested to identified the sap of the tree, Ficus septica, as a promising&#xD;
      antibacterial agent in vitro. The sap displays comparable activity to chlorhexidine in disc&#xD;
      diffusion assays with gram-positive bacterial wound pathogens. It also appears to dampen the&#xD;
      pro-inflammatory responses of neutrophils by down regulating interleukin-6 expression. The&#xD;
      sap forms a flexible plastic-like wound covering which may help deter flies from feeding on&#xD;
      the wounds, and unlike chlorhexidine cream, the Ficus tree is easy to find where affected&#xD;
      communities live. For this reason, this study aims to perform an open label clinical trial&#xD;
      using an interventional approach, to compare the effect of this antiseptic plant sap and of a&#xD;
      standard topical antiseptic, on the rate of wound development prevention and bacterial&#xD;
      growth. If shown to be effective, this readily available plant medicine can provide a&#xD;
      zero-cost treatment option in remote areas of PNG.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2019</start_date>
  <completion_date type="Actual">November 25, 2019</completion_date>
  <primary_completion_date type="Actual">November 22, 2019</primary_completion_date>
  <phase>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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Assessor of healing outcomes through pictures will not know the arm of origen of the pictures .</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with Clinical Healing in each arm</measure>
    <time_frame>21 days</time_frame>
    <description>surface reduction by more than 50%</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with Clinical Healing in each arm</measure>
    <time_frame>21 days</time_frame>
    <description>Ulcer healing determined by a professional dermatologist, described as as: appearance of granulation tissue, healed borders, dry ulcer, no exudation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in wound microbiology</measure>
    <time_frame>21 days</time_frame>
    <description>Up to five key pathogens identified by next generation sequencing of wound fluids will be quantified at Day 0 and at Day 21 for samples from each arm of the study</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Yaws; Cutaneous</condition>
  <condition>Cutaneous Ulcer</condition>
  <condition>Yaws</condition>
  <arm_group>
    <arm_group_label>Soap and Water</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of care using soap and water</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ficus Septica Sap</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ficus Septica Sap, topical cream, 50ul, daily, for 2 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chlorhexidine (Topical)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Chlorhexidine, topical solution, 50ul, daily, for 2 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Topical antiseptic treatment</intervention_name>
    <description>Prevent the development of bacterial cutaneous ulcers by applying antiseptic sap from Ficus septica tree on small wounds.</description>
    <arm_group_label>Chlorhexidine (Topical)</arm_group_label>
    <arm_group_label>Ficus Septica Sap</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -children aged 5 to 15 with parental consent and with one or more skin breaks of any nature&#xD;
        (i.e. Skin cuts, scratch, scrapes or abrasion and mosquito bites) that are less than 1cm in&#xD;
        major diameter. Written informed consent by parent or guardian will be required before&#xD;
        enrolment.&#xD;
&#xD;
        Exclusion Criteria::&#xD;
&#xD;
          -  All participants who have received medical treatment for skin ulcers up to 2 months&#xD;
             prior to recruitment (azithromycin, amoxicillin, benzathine penicillin, etc.).&#xD;
&#xD;
          -  Patients who require antibiotic treatment for another condition not-related to the&#xD;
             study.&#xD;
&#xD;
          -  Known history of hypersensitivity, allergic or adverse reaction to the study product.&#xD;
&#xD;
          -  Patients presenting cutaneous ulcer more than 1cm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Lihir Medical Centre</name>
      <address>
        <city>Londolovit</city>
        <state>New Ireland Province</state>
        <zip>034</zip>
        <country>Papua New Guinea</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Papua New Guinea</name>
      <address>
        <city>Port Moresby</city>
        <country>Papua New Guinea</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Papua New Guinea</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>September 1, 2020</last_update_submitted>
  <last_update_submitted_qc>September 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Lihir Medical Centre</investigator_affiliation>
    <investigator_full_name>Oriol Mitja</investigator_full_name>
    <investigator_title>Dr. Oriol Mitja</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Skin Ulcer</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Infective Agents, Local</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All individual variables will be available through direct contact with corresponding author</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>After publication of data for 1 year</ipd_time_frame>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04453124
org study id: SAPKOKOPO
nct id: NCT04453124
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In a search for accessible treatment options, plant medicines used by different communities
      in Papua New Guinea have been tested to identify the sap of the tree, Ficus septica, as a
      promising antibacterial agent in vitro.

      This is an open label clinical trial using an interventional approach, to compare the effect
      of the antiseptic plant sap and standard topical antiseptic, on the rate of wound development
      prevention and bacterial growth. If shown to be effective, this readily available plant
      medicine can provide a zero-cost treatment option in remote areas of PNG.
The cutaneous ulcer is a painful and debilitating bacterial infection that is common in rural
      areas of Papua New Guinea (PNG). Systematic treatment with topical antiseptics such as
      chlorhexidine cream in theory represents a viable treatment option, but in reality, effective
      treatment of cutaneous ulcers in Papua New Guinea is greatly hindered by the remote and
      highly inaccessible areas that affected communities often live in. In a search for more
      accessible treatment options, plant medicines used by different communities in Papua New
      Guinea have been tested to identified the sap of the tree, Ficus septica, as a promising
      antibacterial agent in vitro. The sap displays comparable activity to chlorhexidine in disc
      diffusion assays with gram-positive bacterial wound pathogens. It also appears to dampen the
      pro-inflammatory responses of neutrophils by down regulating interleukin-6 expression. The
      sap forms a flexible plastic-like wound covering which may help deter flies from feeding on
      the wounds, and unlike chlorhexidine cream, the Ficus tree is easy to find where affected
      communities live. For this reason, this study aims to perform an open label clinical trial
      using an interventional approach, to compare the effect of this antiseptic plant sap and of a
      standard topical antiseptic, on the rate of wound development prevention and bacterial
      growth. If shown to be effective, this readily available plant medicine can provide a
      zero-cost treatment option in remote areas of PNG.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Assessor of healing outcomes through pictures will not know the arm of origen of the pictures .
measure: Number of participants with Clinical Healing in each arm
time frame: 21 days
description: surface reduction by more than 50%
measure: Number of participants with Clinical Healing in each arm
time frame: 21 days
description: Ulcer healing determined by a professional dermatologist, described as as: appearance of granulation tissue, healed borders, dry ulcer, no exudation.
measure: Changes in wound microbiology
time frame: 21 days
description: Up to five key pathogens identified by next generation sequencing of wound fluids will be quantified at Day 0 and at Day 21 for samples from each arm of the study
arm group label: Soap and Water
arm group type: No Intervention
description: Standard of care using soap and water
arm group label: Ficus Septica Sap
arm group type: Experimental
description: Ficus Septica Sap, topical cream, 50ul, daily, for 2 days
arm group label: Chlorhexidine (Topical)
arm group type: Active Comparator
description: Chlorhexidine, topical solution, 50ul, daily, for 2 days
intervention type: Biological
intervention name: Topical antiseptic treatment
description: Prevent the development of bacterial cutaneous ulcers by applying antiseptic sap from Ficus septica tree on small wounds.
arm group label: Chlorhexidine (Topical)
arm group label: Ficus Septica Sap
criteria: 
gender: All
minimum age: 5 Years
maximum age: 15 Years
healthy volunteers: No
facility: 
facility: 
country: Papua New Guinea
responsible party type: Sponsor-Investigator
investigator affiliation: Lihir Medical Centre
investigator full name: Oriol Mitja
investigator title: Dr. Oriol Mitja
mesh term: Skin Ulcer
mesh term: Ulcer
mesh term: Anti-Infective Agents, Local
sharing ipd: Yes
ipd description: All individual variables will be available through direct contact with corresponding author
ipd info type: Study Protocol
ipd time frame: After publication of data for 1 year