Fekri 2015

Methods	Study design: randomised controlled trial Setting/location: Afzalipour hospital affiliated to Kerman University of Medical Sciences and Dadbin Health Center, Kerman/Iran Study period: not described Sample size calculation: not described
Participants	Type of Leishmania: — Inclusion criteria: age over 7 years, positive smear or biopsy, providing informed consent Exclusion criteria: pregnant or lactating, lesions on face, more than 5 lesions, duration longer than one year, size larger than 3 cm, any treatment in past month, history of allergy to MA or dapsone, systemic diseases, taking immunosuppressive drugs in past 6 months, lupoid or sporotrichoid forms N randomised: 73 Withdrawals: 5 N assessed (lesions): 68 (73). Group 1: 33 (35); group 2: 35 (38) Mean (SD) age: 29.6 years (15.4) in group 1, 31.6 years (20.4) in group 2 Sex (male/female): intervention group: 17/16, group 2: 14/17 Baseline data: Number of lesions: 38 lesions in group 1 and 35 in group 2 Mean±SD of duration of lesions (months): 4.6 ± 9.3 in group 1 and 3.7 ± 1.9 in group 2 Mean±IQR of the initial lesion size (mm2): 2 (1.4‐2.9) in group 1 and 1.5 (1.1‐3) in group 2
Interventions	Type of interventions: Group 1: weekly ILMA + niosomal dapsone gel twice a day Group 2: weekly ILMA + cryotherapy every 2 weeks Duration of intervention: until complete healing or max 16 weeks
Outcomes	Healing response: complete healing (100% epithelialisation and loss of induration), moderate healing (50‐99% epithelialisation and loss of induration), no response (less than 50% epithelialisation and loss of induration) Time points reported: 16 weeks after beginning intervention, 1 year later for recurrence
Notes	Study funding sources: Kerman University of Medical Sciences Possible conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random number table
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgment
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open study
Blinding of outcome assessment (detection bias) All outcomes	High risk	Open study
Incomplete outcome data (attrition bias) All outcomes	High risk	No reasons for missing outcome data
Selective reporting (reporting bias)	High risk	One outcome of interest in the review is not reported: adverse effects, so that it cannot be entered in a meta‐analysis
Other bias	High risk	Sample size calculation and reporting of Leishmania spp involved was not correctly reported