Nilforoushzadeh 2004

Methods	Study design: randomised controlled trial Setting/location: Iran Study period: not described Sample size calculation: not described
Participants	Type of Leishmania: not mentioned Inclusion criteria: CL confirmed with direct smear, aged 1‐20 years, maximum number of lesions 3, maximum size of lesion 5 cm, duration of disease less than 8 weeks Exclusion criteria: history of allergy to MA, pregnancy or lactating N randomised: 210 Withdrawals: 53: 29/105 in group 1 and 24/105 in group 2 N assessed: 157. Group 1: 76, group 2: 81 Age: not described Baseline data: not described
Interventions	Type of interventions: Group 1: combination triple therapy consisting of: 15% PR + 10% urea applied twice daily for 4 weeks, cryotherapy with liquid nitrogen repeated every 2 weeks till complete healing or for a maximum of 3 sessions, ILMA twice every week till complete healing or for a maximum of 6 weeks (in sessions that both cryotherapy and injections were used, cryo was done before injections) Group 2: ILMA twice every week till complete healing or for a maximum of 6 weeks Duration of intervention: 6 weeks
Outcomes	Healing rates: percentage of participants 'cured' 2 weeks after treatment Adverse effects Time points reported: not described
Notes	Study funding sources: not reported Possible conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: insufficient detail was reported about the method used to generate the allocation sequence.
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not described
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	High risk	High rates of dropouts: 53/210 (25.2%)
Selective reporting (reporting bias)	Low risk	The study protocol is not available, but it is clear that the published reports include all expected outcomes
Other bias	High risk	Sample size calculation, reporting of Leishmania spp involved and baseline comparability were not correctly reported