<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/NCT03292835</url>
  </required_header>
  <id_info>
    <org_study_id>ALG 17/003</org_study_id>
    <nct_id>NCT03292835</nct_id>
  </id_info>
  <brief_title>Complex Cutaneous Leishmaniasis Healing Study in Algeria</brief_title>
  <acronym>LeiClean</acronym>
  <official_title>Multicentric Non-Interventional Trial Evaluating Painless Hand Hygiene and LeiProtect® Dressing to Treat Complex Cutaneous Leishmaniasis in Algeria - LeiClean</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>K. W. Stahl</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut Pasteur</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Erlangen-Nürnberg Medical School</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Waisenmedizin e. V. Promoting Access to Essential Medicine</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 study evaluates the effect of clean wound management and dressing on complex zoonotic&#xD;
      cutaneous leishmaniasis caused by L. major in the MENA region (Algeria). The patients will&#xD;
      participate in the wound dressing themselves. The objective is to determine the amount of&#xD;
      patients that can avoid systemic chemotherapy with pentavalent antimony which is compulsory&#xD;
      for patients with complex CL lesions. In Algeria, this requires expensive hospital care&#xD;
      because of the eventual toxic side effects of Sb(V).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigator initiated, non-interventional LeiClean Trial with 100 CL patients presenting&#xD;
      complex CL lesions, normally in need of a systemic an in-door treatment with meglumine&#xD;
      antimoniate and in risk of systemic antimony toxicity (see inclusion criteria!) during the CL&#xD;
      season of 2017/18 is part of the renewed cooperation treaty between the IPA and WM e. V. and&#xD;
      originates from encouraging compassionate use observations after topical LeiClean treatment&#xD;
      authorized by the Algerian Ministry of Health in December 2015. The study will be carried out&#xD;
      in the ZCL region of M'Sila and Bou Saada.&#xD;
&#xD;
      The German Regulation Authority, BfArM, has granted a special approval according to §11 MPG&#xD;
      (German regulation for Medical Devices) to the new filmogenic gel dressing LeiProtect®. The&#xD;
      patients with complex cutaneous leishmaniasis (Giemsa and PCR confirmed) elected for indoor&#xD;
      treatment with systemic antimony treatment are given the option for a LeiClean treatment of&#xD;
      their lesions; they are instructed on hand hygiene and LeiProtect® dressing of their lesions&#xD;
      which they carry out themselves at home during seven days. On day eight they come for lesion&#xD;
      cleansing and photographic monitoring before they start another weekly LeiClean cycle. The&#xD;
      patients can at any time opt for a conventional systemic chemotherapeutic treatment in a&#xD;
      hospital if they are not satisfied with their healing progress. However, if the doctor&#xD;
      realizes that after two months the hygienic wound management results in inadequate healing,&#xD;
      he can also order hospital for the patients. The doctor will allow the patients to visualise&#xD;
      their healing progress over the course of the trial through digital images on the computer.&#xD;
&#xD;
      After complete epithelisation of the lesions, the patients come for controls at monthly&#xD;
      intervals up to a period of five months to check for eventual lesion relapses. The costs of&#xD;
      the LeiClean outdoor treatment will be evaluated and compared to the already known hospital&#xD;
      costs per patient for a three-week systemic indoor Sb(V) treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Political Issues in Algeria and now Covod-19 lock-down&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 1, 2021</start_date>
  <completion_date type="Anticipated">March 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Lesion Epithelisation</measure>
    <time_frame>2 months</time_frame>
    <description>Digital photo documentation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>No healing progress with LeiClean</measure>
    <time_frame>2 months</time_frame>
    <description>Patients who have to be hospitalised for systemic Sb(V) treatment</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Cutaneous Leishmaniases</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LeiProtect®</intervention_name>
    <description>Filmogenic dressing gel</description>
    <other_name>Alcohol Based Hand-Rub (ABHR)</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Polymerase Chain Reaction (PCR). The differentiation of parasite species in between&#xD;
      responders and eventual non-responders using sequencing technologies established in the&#xD;
      Institute of Clinical Microbiology, Immunology and Hygiene, FAU Erlangen and University&#xD;
      Hospital Erlangen.&#xD;
&#xD;
      Smears with Giemsa staining.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        ZCL patients in the CL endemic region of M'Sila and Bou Saada, Algeria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has Giemsa and PCR proven L.major cutaneous leishmaniasis&#xD;
&#xD;
          -  Subject has complex zoonotic cutaneous leishmaniasis or Sb(V) incompatibility&#xD;
&#xD;
          -  Subject gives voluntary consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Immune deficiencies, skin tumours, allergy to 1,2-propylene glycol (rare)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Week</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zoubir Harrat, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pasteur Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NGO Waisenmedizin e. V.</name>
      <address>
        <city>Freiburg</city>
        <zip>79100</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <removed_countries>
    <country>Algeria</country>
  </removed_countries>
  <link>
    <url>http://www.waisenmedizin.org</url>
    <description>Organisation Homepage</description>
  </link>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>September 23, 2020</last_update_submitted>
  <last_update_submitted_qc>September 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Waisenmedizin e. V. Promoting Access to Essential Medicine</investigator_affiliation>
    <investigator_full_name>K. W. Stahl</investigator_full_name>
    <investigator_title>Prof. Dr. Dr.</investigator_title>
  </responsible_party>
  <keyword>complex</keyword>
  <keyword>zoonotic</keyword>
  <keyword>medical device</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>Undecided</sharing_ipd>
  </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/NCT03292835
org study id: ALG 17/003
nct id: NCT03292835
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effect of clean wound management and dressing on complex zoonotic
      cutaneous leishmaniasis caused by L. major in the MENA region (Algeria). The patients will
      participate in the wound dressing themselves. The objective is to determine the amount of
      patients that can avoid systemic chemotherapy with pentavalent antimony which is compulsory
      for patients with complex CL lesions. In Algeria, this requires expensive hospital care
      because of the eventual toxic side effects of Sb(V).
The investigator initiated, non-interventional LeiClean Trial with 100 CL patients presenting
      complex CL lesions, normally in need of a systemic an in-door treatment with meglumine
      antimoniate and in risk of systemic antimony toxicity (see inclusion criteria!) during the CL
      season of 2017/18 is part of the renewed cooperation treaty between the IPA and WM e. V. and
      originates from encouraging compassionate use observations after topical LeiClean treatment
      authorized by the Algerian Ministry of Health in December 2015. The study will be carried out
      in the ZCL region of M'Sila and Bou Saada.

      The German Regulation Authority, BfArM, has granted a special approval according to §11 MPG
      (German regulation for Medical Devices) to the new filmogenic gel dressing LeiProtect®. The
      patients with complex cutaneous leishmaniasis (Giemsa and PCR confirmed) elected for indoor
      treatment with systemic antimony treatment are given the option for a LeiClean treatment of
      their lesions; they are instructed on hand hygiene and LeiProtect® dressing of their lesions
      which they carry out themselves at home during seven days. On day eight they come for lesion
      cleansing and photographic monitoring before they start another weekly LeiClean cycle. The
      patients can at any time opt for a conventional systemic chemotherapeutic treatment in a
      hospital if they are not satisfied with their healing progress. However, if the doctor
      realizes that after two months the hygienic wound management results in inadequate healing,
      he can also order hospital for the patients. The doctor will allow the patients to visualise
      their healing progress over the course of the trial through digital images on the computer.

      After complete epithelisation of the lesions, the patients come for controls at monthly
      intervals up to a period of five months to check for eventual lesion relapses. The costs of
      the LeiClean outdoor treatment will be evaluated and compared to the already known hospital
      costs per patient for a three-week systemic indoor Sb(V) treatment.
observational model: Case-Crossover
time perspective: Prospective
measure: Lesion Epithelisation
time frame: 2 months
description: Digital photo documentation
measure: No healing progress with LeiClean
time frame: 2 months
description: Patients who have to be hospitalised for systemic Sb(V) treatment
intervention type: Device
intervention name: LeiProtect®
description: Filmogenic dressing gel
other name: Alcohol Based Hand-Rub (ABHR)
Polymerase Chain Reaction (PCR). The differentiation of parasite species in between
      responders and eventual non-responders using sequencing technologies established in the
      Institute of Clinical Microbiology, Immunology and Hygiene, FAU Erlangen and University
      Hospital Erlangen.

      Smears with Giemsa staining.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Week
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Zoubir Harrat, Dr.
role: Principal Investigator
affiliation: Pasteur Institute
facility: 
country: Germany
country: Algeria
url: http://www.waisenmedizin.org
description: Organisation Homepage
responsible party type: Sponsor-Investigator
investigator affiliation: Waisenmedizin e. V. Promoting Access to Essential Medicine
investigator full name: K. W. Stahl
investigator title: Prof. Dr. Dr.
mesh term: Leishmaniasis
mesh term: Leishmaniasis, Cutaneous
sharing ipd: Undecided