Firooz 2005

Methods	Study design: randomised controlled trial Setting/location: Isfahan, Iran Study period: 6 months Sample size calculation: not described
Participants	Type of Leishmania: L major endemic in the area Inclusion criteria: the presence of parasitologically confirmed lesion(s) of CL, aged 12‐60 years, and otherwise healthy on the basis of medical history and physical examination Exclusion criteria: women of childbearing age without adequate effective contraception; pregnant or breastfeeding; duration of lesions > 8 weeks; the presence of lesions on face, joints or near the mucous membranes; the presence of > 5 lesions or any lesion with a diameter > 5 cm; history of any antileishmanial therapy in the past 4 weeks N participants randomised (lesions): 72 (106). 36 (53) treated with zinc sulphate (ZS) and 36 (53) treated with ILMA Withdrawals participants (lesions): 37 (56). ZS group 23 (34): unresponsive: 12, lost to follow‐up: 5, non‐medical events: 2, protocol deviation: 2, complications: 1, patient request: 1. ILMA 14 (22): unresponsive: 2, lost to follow‐up: 10, non‐medical events: 1, patient request: 1 N assessed (lesions): 35 (50). 13 (19) treated with ZS and 22 (31) treated with ILMA Mean (SD) age: 20.2. years (9.6). ZS group: 18.1 years (6.1); ILMA: 22.3 years (11.2) Sex (male/female): 33/39. ZS group: 19/17; ILMA group: 14/22. Baseline data: Location of the lesions (n (%)): head and neck: ZS group: 7 (13.2); ILMA group: 1 (1.9); trunk: ZS group: 3 (5.7); ILMA group: 1 (1.9); upper extremity: ZS group: 28 (52.8); ILMA group: 32 (60.4); lower extremity: ZS group: 15 (28.3); ILMA group: 19 (35.8) ZS group: MNL (SD): 1.4 (0.8). MSL (SD): 7.6 mm (5.5). MDLBT: 5.8 weeks (2.0) ILMA group: MNL (SD): 1.5 (0.8). MSL (SD): 7.9 mm (7.5). MDLBT: 5.5 weeks (2.3)
Interventions	Type of interventions: Group 1: IL 2% zinc sulphate Group 2: ILMA Duration of intervention: up to 6 weeks Duration of follow‐up: 5 weeks
Outcomes	Healing rates: percentage of lesions 'cured' 5 weeks after treatment. Complete re‐epithelialisation of each ulcer with marked reduction in induration with or without scarring was considered as the main efficacy parameter. Amount of injection into each lesion Adverse effects: the pain experienced by the participant (using a verbal analogue scale on a 0‐10 scale) was recorded Time points reported: 6 weeks
Notes	Study funding sources: this study was supported by a grant from Chancellery of Research, Tehran University of Medical Sciences. Possible conflicts of interest: none declared The plot and the figures were not matched accordingly
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Table of random numbers
Allocation concealment (selection bias)	Low risk	The randomisation sequence was concealed from the investigators until the data entry was completed and the data bank was locked.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Double‐blind" Comment: the preparation and coding of drugs were done by a pharmacist outside of the research team and investigators were blinded to them
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	High risk	High rate of dropouts (37/72, 54%). Missing outcome data imbalanced in numbers and reasons across intervention groups. ZS group: 23. ILMA group: 14. 'As‐treated' analysis done with substantial departure of the intervention received from that assigned at randomisation
Selective reporting (reporting bias)	Low risk	All relevant outcomes reported
Other bias	High risk	Sample size calculation and reporting of Leishmania spp involved was not correctly reported