Emad 2011

Methods	Study design: randomised controlled trial Setting/location: Iran Study period: not described Sample size calculation: not described
Participants	Type of Leishmania: L major Inclusion criteria: PCR‐proven L major cutaneous infection, age > 12 years, not using anti‐Leishmania therapies during the past 2 months, duration of lesions < 4 moths Exclusion criteria: pregnancy, breastfeeding, presence of lesions on ears and/or face, number of lesions >10, history of liver or kidney disease N randomised: 120 participants (fluconazole 200 mg: 60; fluconazole 400 mg: 60) Withdrawals: 2 in the 400 mg group N assessed: 118 participants Mean (SD) age: fluconazole 200 mg, 36.45 years (15.34); fluconazole 400 mg, 35.38 years (13.81) Sex (male/female): 65/55 (fluconazole 200 mg, 30/30; fluconazole 400 mg, 35/25) Baseline data: Mean number of lesions (SD): fluconazole 200 mg, 3.10 (2.08); fluconazole 400 mg, 3.21 (2.09) Mean duration of lesions (SD): fluconazole 200 mg, 7.12 weeks (2.51); fluconazole 400 mg, 7.43 weeks (2.6) Size of lesions (SD): fluconazole 200 mg, 19.84 mm (8.97); fluconazole 400 mg, 21.87 mm (8.93)
Interventions	Type of interventions: Group 1: high dose fluconazole 200 mg twice daily Group 2: low dose fluconazole100 mg twice daily Duration of intervention: 6 weeks
Outcomes	Complete healing: defined as complete re‐epithelialisation of the lesions at intervals of 2, 4 and 6 weeks Adverse effects Time points reported: 6 weeks
Notes	Study funding sources: grant from Shiraz University of Medical Sciences, Shiraz, Iran 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 then randomized into two equal groups to receive either fluconazole 100 mg or 200 mg twice daily." 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	Not stated
Incomplete outcome data (attrition bias) All outcomes	Low risk	2 dropouts were reported in the fluconazole 400 mg group. ITT analysis were performed.
Selective reporting (reporting bias)	Unclear risk	Our primary outcomes (Complete healing and adverse effects) were described in Methods and reported in Results.
Other bias	Unclear risk	There was not enough information in the publication to assess if there were other biases present.