Al‐Fouzan 1991

Methods	Study design: randomised controlled trial Setting/location: Kuwait Study period: not described Sample size calculation: not described
Participants	Type of Leishmania: L tropica or L major in the area Inclusion criteria: positive for leishmanial parasites (amastigotes) on microscopic examination. Women of childbearing age were instructed to use potent and adequate contraceptive measures before the initiation of treatment. Exclusion criteria: not described N randomised: 24. Oral itraconazole: 15; placebo: 9 Withdrawals: 0 N assessed: N = 24. Oral itraconazole: 15; placebo: 9 Age range: 12‐52 years Sex: male/female: 13/11 Baseline data: single or multiple lesions, active being nodule, nodule‐ulcerative, or ulcerative. The site of lesions including both groups was 75% on upper limbs; 46% on lower limbs; 25% on the face, and 4% on the trunk. The duration of the lesion varied between 1 and 14 months.
Interventions	Type of interventions: Group 1: oral itraconazole 200 mg twice daily. There was a 12‐year‐old boy who was given a dose of 100 mg once daily (3 mg/kg per day) Group 2: placebo capsules twice daily during meals. Duration of intervention: 6‐8 weeks Duration of follow‐up: 12 weeks post‐treatment
Outcomes	Primary outcome: percentage of participants 'cured' 2 months after treatment. The response to treatment was graded as excellent (reduction in size of lesion by 80% up to complete clearance); good (reduction in size of lesion by 50%) and poor when there is minimal or no change of lesion. Secondary outcomes: duration of remission and percentage of people with treated lesions that recur within 6 months and 1, 2, and 3 years (for a period up to 3 months after suspension of the drug) Adverse effects Time points reported: 8 weeks and 12 weeks 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 participants were randomly divided into two groups" Comment: insufficient detail was reported about the method used to generate the allocation sequence.
Allocation concealment (selection bias)	Unclear risk	Quote: "The patients were randomly divided into two groups" No further information about allocation concealment was provided
Blinding of participants and personnel (performance bias) All outcomes	Low risk	The drug and the placebo were supplied in capsules with the same shape. No information about blinding of personnel was provided but it is not likely to add risk of bias being oral administration
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No blinding of outcome assessment was described
Incomplete outcome data (attrition bias) All outcomes	Low risk	No missing outcome data
Selective reporting (reporting bias)	Low risk	Relevant outcomes were reported
Other bias	High risk	Sample size calculation and reporting of Leishmania spp involved was not correctly reported