Farajzadeh 2015

Methods	Study design: randomised controlled trial Setting/location: Afzalipour Hospital, Kerman University of Medical Sciences, Iran Study period: 1 year (2011‐12) 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 topical terbinafine compared with control group
Participants	Type of Leishmania: L tropica Inclusion criteria: participants between 2‐60 years and without serious medical illness were included, not have received any other leishmanicidal treatment during last 3 months, duration of their lesions should be less than 6 months Exclusion criteria: cardiac, hepatic, renal and other systemic diseases; pregnant and nursing women; hypersensitivity to trial drugs N randomised: 80, 40 in each group Withdrawals: 0 N assessed: 80, 40 in each group Mean (SD) age: terbinafine: 16.3 years (14.8), IMMA: 20.74 years (19.4) Sex (n, %): terbinafine: male 18 (45); female 18 (45); the sex of 4 (10) participants was unknown. IMMA: male: 16 (40); female: 18 (45); the sex of 6 (15) participants was unknown Baseline data: Mean duration of lesions (SD): terbinafine: 3.97 months (0.3). IMMA: 3.81 months (0.3) Mean number of lesions (SD): terbinafine: 1.85 (1.3). IMMA: 1.93 (1.16) Mean size of lesions (SD): terbinafine: 4.15 mm² (5.97). IMMA: 5.21 mm² (10.65) The most frequent location of the lesions was on participants' face (terbinafine: n = 99, 45.8% vs IMMA: n = 93, 50%)
Interventions	Type of interventions: Group 1: oral terbinafine, 125 mg/d (for less than 20 kg body weight), 250 mg/d (20‐40 kg body weight), 500 mg/d (for more than 40 kg body weight) Group 2: 15 mg/kg/d IMMA (Glucantime; Haupt Pharma in France) Co‐interventions: Both groups received cryotherapy every 2 weeks for 4 weeks Duration of intervention: group 1: 4 weeks, group 2: 3 weeks Duration of follow up: patients were followed monthly for 3 months after the treatment.
Outcomes	Clinical cure: clinical response was determined based on the following criteria: Complete improvement (decrease in induration size > 75%) Partial improvement (decrease in induration size between 25% and 75%) No improvement (decrease in induration size < 25%) Time to clinical cure: development of oartial and complete response to treatment in IMMA and terbinafine groups. Time points reported: the improving rate determined by measuring indurations at baseline, in the middle (day 10 for IMMA group and day14th for terbinafine group), and at the end of the study (day 21 for IMMA group and day 28 for terbinafine group)
Notes	Study funding sources: Kerman University of Medical Sciences accepted the financial support of this study Possible conflicts of interest: the authors declare that there is no conflict of interest.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The randomisation sequence was obtained by the use of a randomisation table.
Allocation concealment (selection bias)	Low risk	A simple block randomisation list with a block size of 4 was accumulated by a team member who was not involved in the enlistment and follow‐up of the participants. The randomisation allocation concealment was carried out by sending the randomisation numbers in envelopes to a dermatologist who was responsible for giving the assigned treatment after each participant was en‐rolled.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Different administration of treatments: oral terbinafine and IMMA.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	This study was an assessor blind trial in which the outcome assessor was unaware of the drugs used by the participants.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Not described
Selective reporting (reporting bias)	High risk	The study published does not report 2 primary outcomes: adverse effects and recurrence
Other bias	Low risk	Other items assessed correctly reported