Farajzadeh 2016b

Methods	Triple‐blind randomised controlled trial Performed in Shahid Dadbin Clinic of Leishmaniasis Research Center (Iran), at Kerman University of Medical Sciences, between 2008 and 2010 Sample size calculation: a sample size of 44 participants per treatment group was planned with a probability of a type I error at alpha = 0.05 and beta = 0.1 to determine a 20% difference between topical terbinafine and vehicle in outcome.
Participants	Type of Leishmania: L major and L tropica in the area Inclusion criteria: < 2 years of age; parasitological diagnosis of cutaneous leishmaniasis from all lesions with direct smear; ulcerative lesions with duration of less than one month that were not on exposed areas or joints; the size of lesions has to be < 3 cm; ≤ 3 lesions; no anti‐leishmanial therapy during last 2 weeks, and with no history of hypersensitivity to MA Exclusion criteria: pregnant or nursing women, patients with hepatic, renal, or heart diseases N randomised: 88, 44 in each group Withdrawals: 36 in topical terbinafine + MA; 29 in vehicle + MA N assessed (3 months): 9 in topical terbinafine + MA; 15 in vehicle + MA There are significant differences between participants' sex in intervention and control groups
Interventions	Group 1: IMMA 20 mg/kg/d + topical terbinafine for 20 days 3 months follow‐up after completing of the treatment phase Group 2: IMMA 20 mg/kg/d + vehicle (Mahan Vaseline) for 20 days Visited at days: 0, 14, 30 and 44
Outcomes	Clinical cure, defined as: Complete improvement: full re‐epithelialisation for ulcerative lesions and decrease in induration size(75%, with or without a negative direct smear result) Partially improved: decrease in the indurations size between 25% and 75% No change: decrease in the indurations size of 25% Time to healing (partial/complete treatment)
Notes	Study funding sources: none declared Possible conflicts of interest: there is no conflict of interest.