Nilforoushzadeh 2014b

Methods	Study design: randomised controlled trial Setting/location: Skin Disease and Leishmaniasis Research Center, Iran Study period: not described Sample size calculation: not described
Participants	Type of Leishmania: not described Inclusion criteria: participants with positive direct smear for CL; 6‐60 years of age; without any previous history of systemic or topical therapy for CL; lesions < 3 cm, < 12 week duration, and not located within 2 cm distance of palpebral margin Exclusion criteria: pregnant and lactating women N randomised: 200 participants Withdrawals: not described N assessed: 187; group 1: 91; group 2: 96 Mean (SD) age: 10.7 years (22.04); group 1: 10 years (20.6); group 2: 11.3 years (23.3) Sex (male/female): 101/86 Baseline data: mean (SD) lesion area was 329 mm² (118.7) in group 1 and 359 mm² (55.6) in group 2
Interventions	Type of interventions: Group 1: ILMA + 50% TCA was performed twice a week Group 2: ILMA alone was performed twice a week Duration of intervention: complete resolution of the lesions or end of 8 weeks
Outcomes	Clinical cure: complete re‐epithelialisation of the lesion and lack of induration. Clinical response was measured at the end of treatment and was defined as complete cure (negative direct smear and clinical healing), partial cure (partial clinical improvement with decreasing erythema, induration, and lesion size), non‐cure or treatment failure (no clinical change or worsening of the lesions) Time points reported: 8 weeks
Notes	Study funding sources: the study is self‐funded Possible conflicts of interest: there is no conflict of interest
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random allocation software (version 1.0, May 2004, Saghaei) was used for randomisation
Allocation concealment (selection bias)	Low risk	Participants with confirmed cutaneous leishmaniasis referred to the Skin Diseases and Leishmaniasis Research Center were selected and randomised by random allocation software into 3 groups
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open trial
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "The measurements were done before treatment and at the end of eighth week by the investigators who were blinded to the type of treatment." Comment: Lesions were photographed before and after completion of the treatment course. Not clear how blinding was preserved
Incomplete outcome data (attrition bias) All outcomes	Low risk	From a total of 200 randomised participants, 96 participants in ILMA group and 91 participants in the combination group completed the study Losses to follow‐up were below 25% and homogeneous between the groups
Selective reporting (reporting bias)	High risk	Protocol not available, not registered. Adverse effects not reported
Other bias	High risk	Sample size calculation and reporting of Leishmania spp involved was not correctly reported