Iraji 2004

Methods	Study design: randomised controlled trial Setting/location: Department of Dermatology, Isfahan Medical University, Iran Study period: 10 months Sample size calculation: not described
Participants	Type of Leishmania: Leishmania spp: due to a previous study in the area, it was likely that participants were infected with L major Inclusion criteria: proven leishmaniasis based on typical lesions of ACL and a positive direct smear. Number of lesions < 4 and duration of lesion < 12 weeks Exclusion criteria: cases of reinfection, pregnant or nursing women, those who had lesion on the face or joints and participants with sporotrichoid or erysipeloid lesions N randomised: 104. ILMA: 55, zinc sulphate (ZS): 49 Withdrawals: 38. ILMA: 20, ZS: 18. 13 due to occurrence of new lesions: 7 from ILMA group and 6 from ZS group; 6 participants with sporotrichoid spread: 4 from the ILMA group and 2 from the ZS group; 19 participants lost to follow‐up: 9 from the ILMA group and 10 from the ZS group N assessed: 66. ILMA: 35, ZS: 31 Mean age (range): ILMA: 11 years (2‐67); ZS: 12 years (3‐64) Sex (male/female): 50/54. ILMA: 14/21; ZS: 17/14 Baseline imbalances: sex distribution in each group Severity of illness: Mean duration of lesions (SD) (weeks): ILMA: 6.73 ±0.53 ;ZS: 7.64±0.12 .
Interventions	Type of interventions: Group 1: ILMA injection of 50 mL Group 2: IL ZS injection of 50 mL In cases where there was a slight to mild improvement, another injection was given after 2 weeks Duration of intervention: 2‐6 weeks Duration of follow‐up: 6 weeks
Outcomes	Healing rates: percentage of participants 'cured' at the end of treatment. The results of treatment were graded according to the system of Sharquie 1997 slight = 1, mild = 2, moderate = 3, marked = 4, 5 = total clearance of the lesion and parasite not detected in the affected area by smear Adverse effects Time points reported: 2, 4, 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	Comment: insufficient detail was reported about the method used to generate the allocation sequence
Allocation concealment (selection bias)	Unclear risk	Insufficient information
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Participants were treated randomly with intralesional injection of any of 2 similar 50‐mL vials marked A (MA) or B (ZS) by an independent physician. ZS solution was prepared by dissolving 2 g ZS (ZNSO4W 7H2O) per 100 mL of bidistilled deionised water. The blinding was unlikely to have been broken.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information to permit judgment
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's pre‐specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre‐specified way
Other bias	High risk	Sample size calculation, reporting of Leishmania spp involved and baseline comparability was not correctly reported