Efficacy of Radio-frequency Induced Heat (RFH)Therapy in Treatment of Cutaneous Leishmaniasis in India
Condition: Cutaneous Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): RFH therapy; Sodium stibogluconate
Intervention type(s): Other; Drug
Intervention description(s): 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.; Six intralesional injections (one injection per week) of SSG 50mg/cm-2 area of lesions
Other intervention name(s): Heat therapy; Glucantine; SSG
Intervention MeSH terms: Antimony Sodium Gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cutaneous leishmaniasis, heat therapy, antimony