A clinical trial to assess the safety and effect of heat therapy in comparison to standard intra-lesional sodium stibogluconate for cutaneous leishmaniasis

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Once the patients were eligible to participate in the trial, they were briefed about the study, its aims and protocol by the investigator. Informed written consent was obtained from the patients by a trained research assistant to avoid any bias ( the investigator refrained from taking consent). The clinical trial data form was completed and photographs of the baseline lesions were taken. The clinical trial data form was filled to obtain demographic and clinical details with regard to baseline size and type of lesion. Patients then proceeded to the nursing officer to be randomized into one of the arms of the trial. The assigned treatments are as follows:- Thermotherapy ( Test group) Heat therapy was administered as a single session. The lesion and surrounding normal skin was cleaned with normal saline. Then the area was anasthetized with 2% lignocaine using a 1cc syringe .The device was used in according to manufacturers instructions (ThermoMed 1.8 ;Thermosurgery) . It generates a 6.78 mHz frequency applied with a hand set that is attached to two applicator electrodes which were placed on the diseased skin. A temperature of 50 degrees centigrade was applied for 30 seconds to cover an area about 49-73 mm2 according to the size of electrodes ( three sizes are provided). Then the applicator is moved to another area of the lesion until the entire area is treated. Once treatment begins the temperature is measured by a thermistor embedded in the applicator which ensures that the applied temperature remains constant. After treatment the lesions were covered with gauze to prevent secondary infections and patients were given an antibiotic cream( soframycin( 1% in 30 grams) as much as required to cover the lesion) to be applied twice a day for 3 days. SSG (control group) One of the trained medical officers administered branded SSG, Pentostam using a 1cc syringe with a fixed needle after the lesion was cleaned with normal saline .SSG was administered intra-lesionally until complete blanching of the lesion and its margins.The injection was given at right angles to the lesion to infilterate in a “v”shaped pattern that ended with the needle being advanced to the base of the lesion.Depending on the size of the lesion the dose varied from about 1-3 ml given weekly until cured or up to 10 weeks .The same medical officer treated all the patients to minimize variations. Patients were followed up fortnightly up to 12 weeks and then monthly up to the 4th month to assess response to treatment and then after 3 months of complete cure to assess for any relapse or recurrence.The clinical trial data form was completed at every follow up visit with regard to size of lesion, degree of re-epithilialization , whether cured or not , whether further treatment was required and remarks were documented. Photographs were taken at each visit and were saved in folders for each patient. The occurrence of adverse effects were evaluated by asking patients and examining lesions and were documented in the remarks section of the data form.

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