Asilian 2003

Methods	Study design: randomised controlled trial Setting/location: 3 primary health centres around Borkhar district north of Isfahan, Iran Study period: not described Sample size calculation: determined on the basis of a 2‐week cure rate of 50% at day 45 and unexpected 4‐week cure rate of 70%
Participants	Type of Leishmania: L major Inclusion criteria: participants with a single parasitologically confirmed lesion, < 5 cm in diameter Exclusion criteria: lesions duration > 4 months and < 2 years, pregnant or nursing mothers, treated previously, any intercurrent illness or history of allergy to aminoglycoside N randomised: 233. 117 were allocated to receive 4 weeks of active treatment and 116 to receive 2 weeks of active treatment Withdrawals: 17, 9 in 4 weeks of active treatment and 8 in 2 weeks of active treatment N assessed: 216, 108 in each group. Mean age (SD): 4 weeks of active treatment: 9.2 years (8.9); 2 weeks of active treatment: 9.0 years (8.8) Sex ratio (male/female): 4 weeks of active treatment: 47/53; 2 weeks of active treatment: 44/56 Baseline data: ulcerated lesion (SD): 4 weeks of active treatment 85 (79); 2 weeks of active treatment 95 (88)
Interventions	Type of interventions: Group 1: PR (aminosidine) ointment for 4 weeks n = 117. Mean number of lesions: 1. Group 2: PR (aminosidine) ointment for 2 weeks followed by 2 weeks of paraffin = 116. Mean number of lesions: 1 Co‐interventions: if lesions were bad enough, they were treated with antimonate Duration of follow‐up: 105 days after starting treatment
Outcomes	Healing rates: 'Clinical cure' was defined as > 50% re‐epithelialisation of the original lesion, and 'clinical and parasitological cure' as either complete re‐epithelialisation or clinical cure plus a parasitologically negative smear. The primary study endpoints were clinical cure and clinical and parasitological cure at day 29, when the 4 weeks of active treatment ended Adverse effects Tertiary outcomes: microbiological or histopathological cure of skin lesions Time points reported: days 29, 45, 105
Notes	Study funding sources: this investigation was supported by the UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases Possible conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation list after participants returned their first used tube after 2 weeks
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgment
Blinding of participants and personnel (performance bias) All outcomes	Low risk	The vehicle and active ointments looked and smelled identical. Outcome is not likely to be influenced by the lack of blinding.
Blinding of outcome assessment (detection bias) All outcomes	High risk	The clinical and parasitological evaluators were blinded to each other's assessment. All efforts were made to reduce the introduction of bias into this study; however, duration of the lesion, which was self‐reported by the participants or their guardians, could introduce bias if the durations were significantly different in the 2 arms by chance.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups.
Selective reporting (reporting bias)	Low risk	The study protocol is not available, but it is clear that the published reports include all expected outcomes, including those that were pre‐specified
Other bias	Low risk	Other items assessed correctly reported