Jowkar 2012

Methods	Study design: double‐blind, randomised placebo‐controlled clinical trial Setting/location: south of Iran Study period: October 2007 to January 2009 (15 months) Sample size calculation: not described
Participants	Type of Leishmania: L major and L tropica Inclusion criteria: men and women aged at least 12 years old, positive smear and/or polymerase chain reaction (PCR) for CL, cutaneous lesions of less than 4 months' duration Exclusion criteria: pregnancy and lactation, facial lesions, lesions of more than 4 months' duration, complete or incomplete treatment with a systemic or topical medication within the previous month, drug sensitivity N randomised: 100 participants Withdrawals: 37 participants N assessed: 63 participants (36 in treatment and 27 in control group) Age: range 12‐62 years (mean 32.6 (SD 12) in the treatment group and 33.1 (14) in the vehicle group) Sex (male/female): 35/28 Baseline data: Location of lesion(s): treatment: arm 12, hand 5, wrist 5, leg 7, foot 5, trunk 1, neck 1; control: arm 5, hand 7, wrist 4, leg 5, foot 2, trunk 2, neck 2 Type of lesion: treatment: plaque 19 and nodule 17; control: plaque 14 and nodule 13 Origin of the lesion: treatment: rural 24 and urban 12; control: rural 17 and urban 10
Interventions	Type of interventions: Group 1: 3% sodium nitrite in aqueous cream Group 2: aqueous cream alone (vehicle) Duration of intervention: 12 weeks Co‐interventions: simultaneously, cryotherapy once a week and aqueous cream containing 3% salicylic acid (emulsifying ointment 30 g, phenoxyethanol 1 g and freshly boiled and cooled water 69 g)
Outcomes	Clinical response: Complete clinical response: complete re‐epithelialisation of the ulcer and disappearance of induration Partial clinical response: reduction of more than 50% of the ulcer and induration in relation to the last clinical evaluation Absence of clinical response: increase or reduction of less than 50% of the ulcer and the indurated area in relation to the last clinical evaluation Adverse effects Time points reported: 12 weeks
Notes	Study funding sources: not described Possible conflicts of interest: no conflicts of interest
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "This investigation was designed as a 12‐week, double blind, N randomised, placebo‐controlled study and its protocol was approved by the ethics committee of the vice chancellor of research affairs of Shiraz University." Comment: insufficient detail was reported about the method used to generate the allocation sequence
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "The identically coded and packaged creams were applied two times daily." Quote: "The study was blinded to both the patients and the assessing physician."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "The study was blinded to both the patients and the assessing physician."
Incomplete outcome data (attrition bias) All outcomes	High risk	100 participants were enrolled but only 63 completed the study. Reasons for withdrawal were not reported.
Selective reporting (reporting bias)	Low risk	Our primary outcomes (cure and adverse effects) were described in Methods and reported in Results
Other bias	Unclear risk	There was not enough information in the publication to assess if there were other biases present.