<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/NCT03009422</url>
  </required_header>
  <id_info>
    <org_study_id>TASMC-14-OA-371-CTIL</org_study_id>
    <nct_id>NCT03009422</nct_id>
  </id_info>
  <brief_title>Fractional CO2 Laser With Topical Pentostam Treatment for Cutaneous Leishmaniasis.</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will compare the common treatment for cutaneous leishmaniasis with&#xD;
      intra-lesional Pentostam to fractional CO2 laser with topical application of Pentostam.&#xD;
&#xD;
      Outcome will be final scar appearance assesd by two dermatologist and pain measurement by&#xD;
      VAS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      20 healthy patients diagnosed will cutaneous leishmaniasis with more than one lesion will be&#xD;
      recruited.&#xD;
&#xD;
      Half of the lesions will be treated with intra-lesional injections of Pentostam, and the&#xD;
      other half by CO2 laser with topical application of Pentostam.&#xD;
&#xD;
      Each lesion will recieve 3 treatments, one month apart between treatments. The patients will&#xD;
      scale pain level of each treatment. Final scar appearance will be assessed by two&#xD;
      dermatologists, without knowing what treatment was applied to each lesion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>November 2014</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">February 2017</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>scar appearance</measure>
    <time_frame>At sixth month</time_frame>
    <description>Each lesion will be photographed prior to treatment and at 6th month (Three months after last (3rd) treatment).Two dermatologist will asses each lesion outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain assessed by VAS</measure>
    <time_frame>at one month, two months, and three months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Leishmaniasis</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CO2 fractional laser with local application of Pentostam</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intra-lesinal Pentostam injedction</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Local application pentostam</intervention_name>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>intra-lisional pentostam</intervention_name>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>fractional CO2 laser</intervention_name>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Objective cutaneous leishmaniasis diagnosis.&#xD;
&#xD;
          -  More than one Lesion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous treatment&#xD;
&#xD;
          -  Abnormal scarring&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Monge-Maillo B, Lopez-Velez R. Therapeutic options for old world cutaneous leishmaniasis and new world cutaneous and mucocutaneous leishmaniasis. Drugs. 2013 Nov;73(17):1889-920. doi: 10.1007/s40265-013-0132-1.</citation>
    <PMID>24170665</PMID>
  </reference>
  <reference>
    <citation>Al-Natour SH. Update in the treatment of cutaneous leishmaniasis. J Family Community Med. 2009 May;16(2):41-7.</citation>
    <PMID>23012189</PMID>
  </reference>
  <reference>
    <citation>Arfan-ul-Bari, Simeen-ber-Rahman. Scar leishmaniasis. J Coll Physicians Surg Pak. 2006 Apr;16(4):294-5.</citation>
    <PMID>16624197</PMID>
  </reference>
  <reference>
    <citation>Kim DW, Hwang NH, Yoon ES, Dhong ES, Park SH. Outcomes of ablative fractional laser scar treatment. J Plast Surg Hand Surg. 2015 Apr;49(2):88-94. doi: 10.3109/2000656X.2014.919927. Epub 2014 May 21.</citation>
    <PMID>24845386</PMID>
  </reference>
  <reference>
    <citation>AlGhamdi K, Khurrum H. Successful treatment of atrophic facial leishmaniasis scars by co2 fractional laser. J Cutan Med Surg. 2014 Nov;18(6):379-84. doi: 10.2310/7750.2014.13175.</citation>
    <PMID>25348758</PMID>
  </reference>
  <reference>
    <citation>Sklar LR, Burnett CT, Waibel JS, Moy RL, Ozog DM. Laser assisted drug delivery: a review of an evolving technology. Lasers Surg Med. 2014 Apr;46(4):249-62. doi: 10.1002/lsm.22227. Epub 2014 Mar 24.</citation>
    <PMID>24664987</PMID>
  </reference>
  <reference>
    <citation>Bloom BS, Brauer JA, Geronemus RG. Ablative fractional resurfacing in topical drug delivery: an update and outlook. Dermatol Surg. 2013 Jun;39(6):839-48. doi: 10.1111/dsu.12111. Epub 2013 Jan 7.</citation>
    <PMID>23294061</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>December 30, 2016</last_update_submitted>
  <last_update_submitted_qc>December 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</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>Leishmaniasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antimony Sodium Gluconate</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03009422
org study id: TASMC-14-OA-371-CTIL
nct id: NCT03009422
lead sponsor: 
has dmc: No
The investigators will compare the common treatment for cutaneous leishmaniasis with
      intra-lesional Pentostam to fractional CO2 laser with topical application of Pentostam.

      Outcome will be final scar appearance assesd by two dermatologist and pain measurement by
      VAS.
20 healthy patients diagnosed will cutaneous leishmaniasis with more than one lesion will be
      recruited.

      Half of the lesions will be treated with intra-lesional injections of Pentostam, and the
      other half by CO2 laser with topical application of Pentostam.

      Each lesion will recieve 3 treatments, one month apart between treatments. The patients will
      scale pain level of each treatment. Final scar appearance will be assessed by two
      dermatologists, without knowing what treatment was applied to each lesion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: scar appearance
time frame: At sixth month
description: Each lesion will be photographed prior to treatment and at 6th month (Three months after last (3rd) treatment).Two dermatologist will asses each lesion outcome
measure: Pain assessed by VAS
time frame: at one month, two months, and three months
arm group label: Treatment
arm group type: Experimental
description: CO2 fractional laser with local application of Pentostam
arm group label: control
arm group type: Active Comparator
description: Intra-lesinal Pentostam injedction
intervention type: Drug
intervention name: Local application pentostam
arm group label: Treatment
intervention type: Drug
intervention name: intra-lisional pentostam
arm group label: control
intervention type: Device
intervention name: fractional CO2 laser
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
citation: Monge-Maillo B, Lopez-Velez R. Therapeutic options for old world cutaneous leishmaniasis and new world cutaneous and mucocutaneous leishmaniasis. Drugs. 2013 Nov;73(17):1889-920. doi: 10.1007/s40265-013-0132-1.
PMID: 24170665
citation: Al-Natour SH. Update in the treatment of cutaneous leishmaniasis. J Family Community Med. 2009 May;16(2):41-7.
PMID: 23012189
citation: Arfan-ul-Bari, Simeen-ber-Rahman. Scar leishmaniasis. J Coll Physicians Surg Pak. 2006 Apr;16(4):294-5.
PMID: 16624197
citation: Kim DW, Hwang NH, Yoon ES, Dhong ES, Park SH. Outcomes of ablative fractional laser scar treatment. J Plast Surg Hand Surg. 2015 Apr;49(2):88-94. doi: 10.3109/2000656X.2014.919927. Epub 2014 May 21.
PMID: 24845386
citation: AlGhamdi K, Khurrum H. Successful treatment of atrophic facial leishmaniasis scars by co2 fractional laser. J Cutan Med Surg. 2014 Nov;18(6):379-84. doi: 10.2310/7750.2014.13175.
PMID: 25348758
citation: Sklar LR, Burnett CT, Waibel JS, Moy RL, Ozog DM. Laser assisted drug delivery: a review of an evolving technology. Lasers Surg Med. 2014 Apr;46(4):249-62. doi: 10.1002/lsm.22227. Epub 2014 Mar 24.
PMID: 24664987
citation: Bloom BS, Brauer JA, Geronemus RG. Ablative fractional resurfacing in topical drug delivery: an update and outlook. Dermatol Surg. 2013 Jun;39(6):839-48. doi: 10.1111/dsu.12111. Epub 2013 Jan 7.
PMID: 23294061
responsible party type: Sponsor
mesh term: Leishmaniasis
mesh term: Antimony Sodium Gluconate