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

INTERVENTION: 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 fr CONDITION: Cutaneous Leishmaniasis; ; Cutaneous Leishmaniasis Infection ‐ Other infectious diseases Skin ‐ Other skin conditions PRIMARY OUTCOME: The primary outcome is a composite outcome and falls under the first study objective "To compare the efficacy of thermotherapy treatment to an IL course of MA for the treatment of cutaneous leishmaniasis at three months post treatment in Syria."; ; The primary study outcome is: "Complete re‐epithelization for ulcerated lesions, and obvious flattening for non‐ulcerated lesions measured at 3 months post treatment completion."; ; Photographs of the lesions pre‐ and post‐treatment will be taken and sent to two dermatologists, who are blinded to treatment arm and determine the outcome (treatment success or failure) independently from each other. In case the two dermatologists disagree on the outcome, a third dermatologist, equally blinded, will determine the outcome. ; [3 months post treatment completion.] SECONDARY OUTCOME: The secondary outcome is a composite secondary outcome and falls under the second objective of the trial "Determine leishmania species, genotypes & molecular markers of antimonial resistance." ; ; The secondary outcome is: "PCR of kinetoplast DNA (species), sequence internal transcriber spacer 2 and cytochrome b genes (genotype), gene expression of e.g. aquaglyceroporin 1, multidrug resistance protein A." ; [Samples will be taken post‐treatment completion to then determine the leishmania species, genotypes & molecular markers of antimonial resistance] The inclusion criteria are as follows: 1. Participant with clinically diagnosed Old World Cutaneous Leishmaniasis < 4 cm in size 2. Participant is willing and able to give informed consent for participation in the study or 3. For children at least 5 years, a parent or guardian gives informed consent on their behalf 4. Participant agrees to follow the study processes and attend the follow‐up appointment 3 months post treatment completion INCLUSION CRITERIA: All patients who present to the 5 selected static health facilities and mobile treatment clinics with Cutaneous Leishmaniasis lesions will be eligible for inclusion in this study if they meet all of the inclusion criteria and none of the exclusion criteria.