Salmanpour 2001

Methods	Study design: randomised controlled trial Setting/location: Iran Study period: 18 months Sample size calculation: not described
Participants	Type of Leishmania:Leishmania spp: L tropica and L major Inclusion criteria: patient with CL confirmed parasitologically by direct skin smears or skin biopsies. Exclusion criteria: children < 3 years of age, pregnant and lactating women, cases with concomitant renal, liver or heart disease, and any event of any laboratory abnormality prior to initiation of treatment N randomised: 96 Withdrawals: 0 N assessed: 96 (100%): 64 in the ketoconazole group and 32 in the ILMA group Age: range 3‐64 years Sex (male/female): 44/52 Baseline data: In the ketoconazole group: Mean duration of lesions (SD): 2.6 months (1.4) Mean number of lesions: 2.5 In the MA group: Mean duration of lesions (SD): 3.1 months (1.4) Mean number of lesions: 2.3
Interventions	Type of interventions: Group 1: ketoconazole orally (adults: 600 mg/d for 30 days and children: 10 mg/kg/d for 30 days) Group 2: ILMA 6 injections (some received up to 8) Duration of intervention: 30 days in the ketoconazole group. There is no mention about frequency of injections in MA group.
Outcomes	Healing rates: Cured if lesions had completely re‐epithelialised with little or no scarring at 6 weeks post‐treatment. Failure if participants showed one of the following findings: < 25% reduction in the diameter of induration after 4 weeks of treatment; the persistence of lesions 6 weeks post‐treatment Relapse of disease after initial healing at 6 weeks post‐treatment Adverse effects Time points reported: participants were followed every 2 weeks for the duration of the treatment and every 6 weeks after cessation of treatment up to 24 weeks
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)	Unclear risk	Quote: "Patients were randomly allocated to two treatment groups using a simple randomisation method" Comment: insufficient detail was reported about the method used to generate the allocation sequence.
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgment
Blinding of participants and personnel (performance bias) All outcomes	High risk	Group 1, which included 64 participants, was designated as the group treated with oral ketoconazole. Group 2, which included 32 participants, was designated as the group that received ILMA. The outcome is likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information to permit judgment
Incomplete outcome data (attrition bias) All outcomes	High risk	Imbalance in numbers and reasons for missing data across intervention groups: 7/57, ketoconazole; 9/23, ILMA
Selective reporting (reporting bias)	Unclear risk	Insufficient information to permit judgment
Other bias	Unclear risk	There was not enough information in the publication to assess if there were other biases present.