Bumb 2013

Methods	Study design: randomised, phase I, open‐label, clinical trial Setting/location: Department of Dermatology at SP Medical College and PBM Hospital, Bikaner, India Study period: June 2009 to December 2010 (19 months) Sample size calculation: not described
Participants	Type of Leishmania: L tropica Inclusion criteria: aged ≥ 4 years, 4 or fewer lesions, a parasitologically confirmed diagnosis of CL by demonstration of organisms (L tropica bodies) in the lesion smear or biopsy Exclusion criteria: included lesion size > 5 cm diameter, prior treatment failure with SSG, treatment for CL within 2 months of enrolment into the study, any chronic condition that might prevent the patient from completing the study therapy and subsequent follow‐up N randomised: 100; radiofrequency‐induced heat therapy (RFHT): 50; ILSSG: 50 Withdrawals: not described N assessed: 100 Median (range) age: RFHT: 20 years (4‐70); ILSSG: 20.5 years (4‐85) Sex: RFHT: male 27, female 23; ILSSG: male 20, female 30 Baseline data: Number of lesions: median (range); RFHT: 1 (1‐7); ILSSG: 1 (1‐4) Number of lesions per participant (%): 1 lesion: RFHT, 30 (60); ILSSG: 32 (64). 2 lesions: RFHT, 14 (28); ILSSG: 13 (26). > 2 lesions: RFHT, 6 (12); ILSSG, 5 (10) Median size of lesions (range): RFHT, 2 cm (0.5‐5); ILSSG, 2 cm (0.5‐14) Median duration of illness (range): RFHT, 3 months (1‐9); ILSSG, 3 months (1‐18)
Interventions	Type of interventions: Group 1: the RFHT group received a single application of a controlled and localised delivery of radiofrequencies into lesions for 30–60 s depending on the thickness of the lesion. The application was performed under local anaesthesia (1% lidocaine) using a current field radiofrequency generator (ThermoMed 1.8) Group 2: ILSSG group, the participants were treated with an intralesional injection of SSG (50 mg/cm² of lesion), twice a week for 7 injections Duration of intervention: RFHT, 5 days; ILSSG, 4 weeks Co‐interventions: all participants were prescribed oral nonsteroidal anti‐inflammatory drugs and topical antibacterial cream (fusidic acid cream) for 5 days
Outcomes	Cure rate, assessed as follows: Complete cure: the total re‐epithelialisation of the lesions Partial cure: decreased induration and erythema Time points reported: 6, 8, 10, 12, 16, and 20 weeks after the initiation of treatment, and at 5, 6, 9, 12 and 18 months post‐treatment
Notes	Study funding sources: none reported Possible conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "The patients were N randomised in a 1:1 ratio" Comment: insufficient detail was reported about the method used to generate the allocation sequence.
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "The clinician who recorded healing was blinded to the modality of treatment." Comment: not clear how the assessor was blinded
Incomplete outcome data (attrition bias) All outcomes	High risk	No information about numbers or reasons for withdrawals during treatment. It seems that there was withdrawals only in the follow‐up: 44% at 18 months in RFHT group and 16% at 18 months in the SSG group. Losses to follow‐up were heterogeneous between groups and no ITT analyses were performed.
Selective reporting (reporting bias)	Low risk	Outcomes of interest were reported in results
Other bias	Unclear risk	There was not enough information in the publication to assess if there were other biases present.