Study to compare thermotherapy and intralesional drug injection for the treatment of patients with cutaneous leishmaniasis lesions in Syria.

The study will compare two treatments for cutaneous leishmaniasis: intralesional meglumine antimoniate (IL MA) and thermotherapy. IL MA is the standard treatment for CL in Syria, making thermotherapy the interventional treatment. The device used in this study – ThermoMed Model 1.8 (Thermosurgery Technologies, Inc., Inc, Phoenix, AZ) - has received both Food and Drug Administration (FDA) and WHO approval for use in treatment of CL and is already in use by MENTOR in Syria. The handheld ThermoMed 1.8 device delivers controlled localised radio frequencies to small areas of tissue, which generates heat that is tolerable to healthy cells but intolerable for abnormal cells as well as parasites. The operating frequency is 6.78 MHZ +/- 15 KHZ and the output power 7 watts (+/-1). The application follows several steps, which are laid out in a Standard Operating Procedure document, which is present at every treatment location. The application is as follows: (a) After the applicator is properly placed on patient, depress handset button. (b) Temperature will ramp up to the selected temperature. The ThermoMed will automatically terminate treatment after 4 seconds of the applicator is not making contact with the tissue being treated. Treatment will also be terminated if ramp-up (time to reach selected temperature) exceeds 45 seconds. If no treatment is administered for 15 seconds, the ThermoMed will automatically shut down. (c) During ramp up to the temperature selected (50 degrees Celsius) the ThermoMed will produce a steady tone of increasing pitch to indicate the temperature sensed by the applicator thermocouple. The red light on the handset will be on. After the selected temperature (50 degrees Celsius) is reached: - The audio output will change from a steady tone to a tone that beeps every 2 seconds - The red light on the handset will change from steady to blinking (e) After 30 seconds at the selected temperature: - The ThermoMed will emit a 1 second tone burst. - The red light on the handset will be on for the same interval as the tone. - The first (30) indicator light on the ThermoMed unit will be turned on (red). Standard treatment for CL with thermotherapy consists of 1 treatment session with application of the ThermoMed device for a duration of 30 seconds at a selected heat of 50 degrees Celsius to each treated area. Larger lesions may require more than 1 application during the same session to cover the entire lesion area. For smaller lesions 1 application of the ThermoMed device will suffice. For patients with several CL lesions, all lesions may be treated during the same treatment session. No further treatment sessions are required. Lesions on or directly adjacent to lips, eyes/eyelids, nose, ears, fingers/toes, close to close to carotid and jugular vessels in neck, the antecubital fossa region or on volar aspect of wrist joint should not be treated using this device. Implantable cardiac devices such as pacemakers and metallic implants such as metal plates in skull also exclude a patient from receiving this treatment. All treatments with the thermotherapy device will take place in either a health facility or a mobile leishmaniasis clinic and all staff that administer the treatment must at least have a nursing degree. As with the MA injections, adherence to the treatment will be monitored through the patient registration book, which is present at each MENTOR-supported health facility as well as all mobile leishmaniasis clinics and via the case report form (CRF) designed for this trial.