Dogra 1996

Methods	Study design: randomised controlled trial Setting/location: India Study period: not described Sample size calculation: not described
Participants	Type of Leishmania:L major and tropica in the area Inclusion criteria: participants with localised CL. Demonstration of parasites from skin lesions by slit smear examination Exclusion criteria: women of child‐bearing age, children < 18 years old, participants suffering from any chronic illness, immunocompromised, prior therapy for CLs in any form, scars of healed leishmanial lesions, lesions of 4 months or more duration, participants showing abnormality in liver function tests N randomised: 20 Withdrawals: 0 N assessed: 20 (100%) Age: range 19‐62 years Sex: 15 males/5 females Baseline data: the duration of the lesions ranged from 2 weeks to 16 weeks, they were mainly seen on exposed parts of the body. 9 had a single lesion and 11 participants had a multiple lesion.
Interventions	Type of interventions: Group 1: itraconazole orally (2 100 mg capsules) for 6 weeks n = 10. 4/10 participants had single lesions. Group 2: placebo orally (2 capsules) for 6 weeks n = 10. 5/10 participants had single lesions. Duration of intervention: 6 weeks Duration of follow‐up: 3 months
Outcomes	Primary outcome: percentage of participants 'cured' 3 months after treatment Secondary outcome: adverse effects Tertiary outcomes: microbiological or histopathological cure of skin lesions Time points reported: clinical response: day 15. Clinical and parasitological response: 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	Quote: "Patients were allocated randomly to receive capsules of itraconazole 100 mg or identical placebo". Comment: insufficient detail was reported about the method used to generate the allocation sequence.
Allocation concealment (selection bias)	Unclear risk	Quote: "Patients were allocated randomly to receive capsules of itraconazole 100 mg or identical placebo". Comment: no further information provided
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "double‐blind therapeutic trial" Comment: participants looks like blinded but no description about personnel blinding was provided
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "double‐blind therapeutic trial" Comment: participants looks like blinded but no description about assessment blinding was provided
Incomplete outcome data (attrition bias) All outcomes	Low risk	No missing outcome data
Selective reporting (reporting bias)	Low risk	All relevant outcomes were reported
Other bias	High risk	Sample size calculation, reporting of Leishmania spp involved and baseline comparability was not correctly reported