<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/NCT01661296</url>
  </required_header>
  <id_info>
    <org_study_id>SPMC/09/10</org_study_id>
    <nct_id>NCT01661296</nct_id>
  </id_info>
  <brief_title>Efficacy of Radio-frequency Induced Heat (RFH)Therapy in Treatment of Cutaneous Leishmaniasis in India</brief_title>
  <official_title>An Open Label Study of RFH Therapy as Treatment for CL Caused by Leishmania Tropica in India</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sarder Patel Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sarder Patel Medical College</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Infections caused by the protozoan parasite Leishmania include cutaneous (CL), mucosal (ML)&#xD;
      and visceral leishmaniasis (VL). Over 12 million people currently suffer from leishmaniasis,&#xD;
      and approximately 2 million new cases occur annually, making it a major global health&#xD;
      problem. CL CL caused by Leishmania tropica is endemic around the city of Bikaner in Thar&#xD;
      Desert region of the State of Rajasthan . WHO recommends antimonials such as sodium&#xD;
      stibogluconate (SSG) to treat CL. However, these drugs are toxic and have poor patient&#xD;
      compliance as they require multiple intramuscular or intralesional injections for 3 weeks. In&#xD;
      addition, the emergence of drug-resistant strains is rapidly increasing worldwide. We are&#xD;
      interested in novel treatments for CL that are safe, easy to administer and effective in&#xD;
      inducing long-term cure. Recently, radio-frequency-induced heat (RFH) therapy has been used&#xD;
      to treat CL. This treatment involves the controlled and localized delivery of&#xD;
      radiofrequencies into lesions for 30-60 seconds under local anesthesia. Several short-term&#xD;
      follow-up (4-5 months) studies as well as one long-term follow-up (12 months) study involving&#xD;
      US soldiers who were infected with L. major in Iraq found that RFH therapy was comparable, or&#xD;
      even better, than systemic antimonials. However, more studies are needed to establish&#xD;
      long-term efficacy of RFH therapy in treatment of CL caused by other Leishmania species that&#xD;
      are difficult to treat with conventional drugs, and to determine the risk of disease&#xD;
      recurrence if any in patients living in Leishmania endemic regions. The goal of this trial is&#xD;
      to compare long term efficacy of RFH therapy in treatment of CL caused by L. tropica in&#xD;
      patients residing in Leishmania-endemic regions of India.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study location and participants: Subjects for this study were recruited among children&#xD;
      between the ages of 1-17 and adults between the ages of 18-85 who visit the dermatology&#xD;
      outpatient clinic at PBM Hospital, Bikaner, with suspected CL. Informed consent was obtained&#xD;
      from adults or from parents/legal guardians of minors for procedures and inclusion in the&#xD;
      study. Individuals with any uncontrolled chronic medical condition, breast feeding, on&#xD;
      immunosuppressive drugs or anticipated unavailability for follow-up were excluded from the&#xD;
      study. Patients with more than 4 lesions were also excluded.&#xD;
&#xD;
      Study procedures: The diagnosis of CL was established by clinical examination, history of&#xD;
      residence in an L. tropica-endemic area, and by microscopic examination of Giemsa-stained&#xD;
      lesion smears for parasites (Leishmania tropica bodies) or lesion biopsy. For patients who&#xD;
      were both smear and skin biopsy negative, PCR was used to detect parasites in the lesion&#xD;
      tissue. The lesion and surrounding skin were cleaned with stabilized 0.1% chlorine dioxide&#xD;
      solution, and local anesthesia was administered by subcutaneous injection of 2% Lidocaine&#xD;
      around the lesion. RFH therapy was administered by a single, controlled and localized&#xD;
      delivery of radio frequencies into the lesion for 30-60 seconds using a current field&#xD;
      radio-frequency generator (ThermoMed 1.8; Thermosurgery Inc. USA). Patients were be&#xD;
      prescribed an oral NSAID and topical antimicrobial cream for 5 days. Cure of infection and&#xD;
      any recurrence was monitored by clinical follow-up at days 10 and months 1, 2, 3, 4, 6, 9, 12&#xD;
      and 18 months post-treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2009</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">August 2011</primary_completion_date>
  <phase>Phase 4</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>Time to heal lesion</measure>
    <time_frame>6 months after treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tissue scarring</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence/Relapse of lesion</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Cutaneous Leishmaniasis</condition>
  <arm_group>
    <arm_group_label>Sodium stibogluconate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intralesional SSG was administered in dose of 50 mg cm -2 of lesion once a week for 6 weeks (total six injections)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RFH therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>RFH therapy was administered by a single, controlled and localized delivery of radio frequencies into the lesion for 30-60 seconds under local anesthesia (1% lidocaine) using a current field radio-frequency generator (ThermoMed 1.8, Thermosurgery Inc).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>RFH therapy</intervention_name>
    <description>RFH therapy was administered by a single, controlled and localized delivery of radio frequencies into the lesion for 30-60 seconds under local anesthesia using a current field radio-frequency generator.</description>
    <arm_group_label>RFH therapy</arm_group_label>
    <other_name>Heat therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium stibogluconate</intervention_name>
    <description>Six intralesional injections (one injection per week) of SSG 50mg/cm-2 area of lesions</description>
    <arm_group_label>Sodium stibogluconate</arm_group_label>
    <other_name>Glucantine</other_name>
    <other_name>SSG</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  parasitologically confirmed diagnosis of cutaneous leishmaniasis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple lesions (more than 4)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ram A Bumb, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>PBM Hospital and SP Medical College, Bikaner, Rajasthan, India</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PBM Hospita and SP Medical College</name>
      <address>
        <city>Bikaner</city>
        <state>Rajasthan</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>August 31, 2012</last_update_submitted>
  <last_update_submitted_qc>August 31, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sarder Patel Medical College</investigator_affiliation>
    <investigator_full_name>Ram Awatar Bumb</investigator_full_name>
    <investigator_title>Professor and Head of the Department of Dermatology</investigator_title>
  </responsible_party>
  <keyword>cutaneous leishmaniasis, heat therapy, antimony</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>
  <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/NCT01661296
org study id: SPMC/09/10
nct id: NCT01661296
lead sponsor: 
collaborator: 
has dmc: Yes
Infections caused by the protozoan parasite Leishmania include cutaneous (CL), mucosal (ML)
      and visceral leishmaniasis (VL). Over 12 million people currently suffer from leishmaniasis,
      and approximately 2 million new cases occur annually, making it a major global health
      problem. CL CL caused by Leishmania tropica is endemic around the city of Bikaner in Thar
      Desert region of the State of Rajasthan . WHO recommends antimonials such as sodium
      stibogluconate (SSG) to treat CL. However, these drugs are toxic and have poor patient
      compliance as they require multiple intramuscular or intralesional injections for 3 weeks. In
      addition, the emergence of drug-resistant strains is rapidly increasing worldwide. We are
      interested in novel treatments for CL that are safe, easy to administer and effective in
      inducing long-term cure. Recently, radio-frequency-induced heat (RFH) therapy has been used
      to treat CL. This treatment involves the controlled and localized delivery of
      radiofrequencies into lesions for 30-60 seconds under local anesthesia. Several short-term
      follow-up (4-5 months) studies as well as one long-term follow-up (12 months) study involving
      US soldiers who were infected with L. major in Iraq found that RFH therapy was comparable, or
      even better, than systemic antimonials. However, more studies are needed to establish
      long-term efficacy of RFH therapy in treatment of CL caused by other Leishmania species that
      are difficult to treat with conventional drugs, and to determine the risk of disease
      recurrence if any in patients living in Leishmania endemic regions. The goal of this trial is
      to compare long term efficacy of RFH therapy in treatment of CL caused by L. tropica in
      patients residing in Leishmania-endemic regions of India.
Study location and participants: Subjects for this study were recruited among children
      between the ages of 1-17 and adults between the ages of 18-85 who visit the dermatology
      outpatient clinic at PBM Hospital, Bikaner, with suspected CL. Informed consent was obtained
      from adults or from parents/legal guardians of minors for procedures and inclusion in the
      study. Individuals with any uncontrolled chronic medical condition, breast feeding, on
      immunosuppressive drugs or anticipated unavailability for follow-up were excluded from the
      study. Patients with more than 4 lesions were also excluded.

      Study procedures: The diagnosis of CL was established by clinical examination, history of
      residence in an L. tropica-endemic area, and by microscopic examination of Giemsa-stained
      lesion smears for parasites (Leishmania tropica bodies) or lesion biopsy. For patients who
      were both smear and skin biopsy negative, PCR was used to detect parasites in the lesion
      tissue. The lesion and surrounding skin were cleaned with stabilized 0.1% chlorine dioxide
      solution, and local anesthesia was administered by subcutaneous injection of 2% Lidocaine
      around the lesion. RFH therapy was administered by a single, controlled and localized
      delivery of radio frequencies into the lesion for 30-60 seconds using a current field
      radio-frequency generator (ThermoMed 1.8; Thermosurgery Inc. USA). Patients were be
      prescribed an oral NSAID and topical antimicrobial cream for 5 days. Cure of infection and
      any recurrence was monitored by clinical follow-up at days 10 and months 1, 2, 3, 4, 6, 9, 12
      and 18 months post-treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time to heal lesion
time frame: 6 months after treatment
measure: Tissue scarring
time frame: 12 months
measure: Recurrence/Relapse of lesion
time frame: 18 months
arm group label: Sodium stibogluconate
arm group type: Active Comparator
description: Intralesional SSG was administered in dose of 50 mg cm -2 of lesion once a week for 6 weeks (total six injections)
arm group label: RFH therapy
arm group type: Active Comparator
description: RFH therapy was administered by a single, controlled and localized delivery of radio frequencies into the lesion for 30-60 seconds under local anesthesia (1% lidocaine) using a current field radio-frequency generator (ThermoMed 1.8, Thermosurgery Inc).
intervention type: Other
intervention name: RFH therapy
description: RFH therapy was administered by a single, controlled and localized delivery of radio frequencies into the lesion for 30-60 seconds under local anesthesia using a current field radio-frequency generator.
arm group label: RFH therapy
other name: Heat therapy
intervention type: Drug
intervention name: Sodium stibogluconate
description: Six intralesional injections (one injection per week) of SSG 50mg/cm-2 area of lesions
arm group label: Sodium stibogluconate
other name: Glucantine
other name: SSG
criteria: 
gender: All
minimum age: 1 Year
maximum age: 90 Years
healthy volunteers: No
last name: Ram A Bumb, MD
role: Principal Investigator
affiliation: PBM Hospital and SP Medical College, Bikaner, Rajasthan, India
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Sarder Patel Medical College
investigator full name: Ram Awatar Bumb
investigator title: Professor and Head of the Department of Dermatology
mesh term: Leishmaniasis
mesh term: Leishmaniasis, Cutaneous
mesh term: Antimony Sodium Gluconate