Efficacy of Radio-frequency Induced Heat (RFH)Therapy in Treatment of Cutaneous Leishmaniasis in India
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
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.