Nilforoushzadeh 2012

Methods	Study design: randomised controlled trial Setting/location: Isfahan University of Medical Science, Isfahan, Iran Study period: March 2008 to March 2009 (12 months) Sample size calculation: not described
Participants	Type of Leishmania: not described Inclusion criteria: unclear Exclusion criteria: pregnant, children < 5 years, palpebral lesions (less than 20 mm from palpebral margin), > 5 lesions, > 12 weeks duration of leishmaniasis, history of any specific anti‐leishmaniasis therapy, significant underlying diseases N randomised: 80 lesions Withdrawals: 4 lesions N assessed: 76 lesions (38 lesions in each group) and 60 patients (30 patients in each group) Mean (SD) age: 5.11 years (13.3) (range 5‐50) Sex: unclear Baseline data: Lesions according to sex: Female: group 1, 16 (42.1%); group 2, 23 (60.5%) Male: group 1, 22 (57.9%) and group 2, 15 (39.5%) Mean size of lesions at the beginning of study was not different between groups (P = 0.58) and was 2.66 cm (SD 0.37) in group and 13.18 cm (SD 0.89) in group 2 Location of lesion: 61/76 lesions in the upper extremities or head: 30/38 lesions (78.9%) in group 1 and 31/38 lesions (81.5%) in group 2 15/76 lesions in the lower extremities: 8 lesions (21.05%) in group 1 and 7 lesions (18.4%) in group 2
Interventions	Type of interventions: Group 1: after cleansing the lesion with alcohol, TCA 50% (Merck, Berlin, Germany) was applied onto the lesion using a cotton swab, until frosting the lesion, once a week and for up to 2 weeks. Afterwards, a controlled localised heating of the lesions was performed using an RF heat generator (4 MHz, maximum output 90 W; Ellman International Inc, NY, USA). The area was heated to 42°C surface temperature for 30 s once a week and for 4 consecutive weeks Group 2: ILMA (Sanofi‐Aventis, France) administered twice a week and continued up to 8 weeks until absolute healing of lesions Duration of intervention: non‐ablative radiofrequency + topical TCA 50%: 4 weeks; ILMA: 8 weeks
Outcomes	Treatment responses: Complete cure: complete clinical healing was defined as complete re‐epithelialisation of the lesions, flattening of the lesions and lack of indurations along with negative direct smear Partial cure: partial clinical improvement along with decreased size of indurations, erythematic areas, and lesions at the end of the treatment Non‐cure or treatment failure: no clinical improvements along with unchanged or even increased size of lesions Time points reported: 6 months of treatment
Notes	Study funding sources: not reported Possible conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "This computer‐based randomised controlled trial was conducted from March 2008 to March 2009"
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	Low risk	Quote: "The examinations and measurements were performed by the investigators who were blinded to the type of treatment."
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Originally 80 lesions were studied and randomly assigned to the 2 groups. However, due to missing data, only 76 were finally included in the analysis. No ITT analysis
Selective reporting (reporting bias)	High risk	Complete cure was described in Methods and Results, but partial cure and treatment failure was not reported in the Results section. No adverse effects reported
Other bias	High risk	Sample size calculation and reporting of Leishmania spp involved was not correctly reported