Dogra 1990

Methods	Study design: randomised controlled trial Setting/location: India Study period: not described Sample size calculation: not described
Participants	Type of Leishmania: L tropica in the area Inclusion criteria: participants with cutaneous Leishmania confirmed by the presence of L tropica bodies in the slit skin smear stained with Leishman stain. Exclusion criteria: women of child‐bearing age N randomised: 20 Withdrawals: 0 N assessed: 20 (100%). Intervention group: 15, control group: 5 Age: range 14‐56 years. Baseline data: single or multiple lesions, the duration of the lesions varied from 4 to 16 weeks
Interventions	Type of interventions: Group 1: itraconazole orally 4 mg/kg per day for 6 weeks (max 200 mg). MNL: 2. MDLBT: 9 weeks Group 2: control group (no treatment) Duration of follow‐up: 6 weeks, but 3 months for relapses assessment
Outcomes	Primary outcome: percentage of participants 'cured' at the end of treatment. The essential criteria for declaring the participant was cured was complete disappearance of the induration or redness in the nodular form and complete healing in the ulcerative form, accompanied by smear positivity conversion Secondary outcomes: duration of remission and percentage of people with treated lesions that recur within 3 months Adverse effects Tertiary outcomes: microbiological or histopathological cure of skin lesions Time points reported: clinical cure: 4 weeks, clinical and parasitological cure: 6 weeks
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	Proportion of 2 to 4:1 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	Unclear risk	Insufficient information to permit judgment
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information to permit judgment
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Insufficient information to permit judgment
Selective reporting (reporting bias)	Unclear risk	All of the study's pre‐specified (primary and secondary) outcomes that are of interest in the review have been reported
Other bias	High risk	Sample size calculation and reporting of Leishmania spp involved was not correctly reported