Farajzadeh 2016a

Methods	Double‐blind randomised controlled trial This study was carried out in some clinics of Kerman University of Medical Sciences (Iran), from October 2008 to December 2010. Sample size calculation: a sample size of 40 participants per treatment group was planned, a probability of a type I error at alpha = 0.05 and beta = 0.1 to determine a 20% difference between intralesional injection of ZS 2 % solution with ILMA (Glucantime)
Participants	Type of Leishmania: L tropica Inclusion criteria: the presence of parasitological confirmed lesion(s) of CL and aged 5–60 years Exclusion criteria: disease duration more than 6 months, those with a history of hypersensitivity to MA (Glucantime) or ZS, pregnant or nursing women, those with more than 5 lesions, those with lesions with size of 5 cm or more, and a history of any anti‐leishmanial therapy during last 4 weeks N randomised: 80, 40 in each group Withdrawals: 34, 18 in the ZS‐treated group and 16 patients in the MA (Glucantime)‐treated group (lost to follow‐up in all of the participants except in one in the ZS‐treated group, who had severe necrosis) N assessed: 46; 22 patients in the ZS‐treated group and 24 patients in the MA (Glucantime)‐treated group There was no significant difference between compared groups' baseline characteristics
Interventions	Group 1: intralesional injection of ZS 2% vials once a week for 10 weeks or sooner in case of complete resolution of the lesions Group 2: ILMA once a week for 10 weeks or sooner in case of complete resolution of the lesions Co‐intervention: in both groups cryotherapy was performed once every other week for 10 weeks
Outcomes	Clinical response: no response to treatment was defined if the area of a lesion decreased less than 75%, partial treatment if decreased 75% to 99%, and complete treatment if decreased 100% compared to its baseline area Time to healing (partial/complete treatment) Adverse effects: there were no major side effects in either group. Pain was observed in all participants of both groups. In ZS group 4 participants developed necrosis of the site of the injection while this was not observed in MA (Glucantime) group at all Time points reported: on average, each participant was followed for 4.1 weeks (SD 2.6).
Notes	Study funding sources: none declared Possible conflicts of interest: there is no conflict of interest