Sadeghian 2006b

Methods	Study design: randomised controlled trial Setting/location: Skin Diseases and Leishmaniasis Research Center in Isfahan, Iran Study period: not described Sample size calculation: not described
Participants	Type of Leishmania:L major endemic in the area. Inclusion criteria: participant with positive smear for Leishman bodies, of both sexes and > 5 years old who did not have indication for systemic therapy Exclusion criteria: facial lesions or lesions on joints, sporotrichoid type, lupoid leishmaniasis, erysipeloid type and other atypical forms of CL, pregnant women, history of cardiovascular and renal diseases N randomised: 72, 36 in each group Withdrawals: 0 N assessed: 72 Mean age: HSCS, 20.52 years; ILMA group, 18.67 years Baseline data: the most common site of lesions was on the extremities and the least common site was the trunk in both groups. The size range of lesions were from 0.5‐4 cm² (IL HSCL group) and from 0.5‐4 cm² (ILMA group)
Interventions	Type of interventions: Group 1: IL HSCL (NaCl 5%; 0.5 to 1 mL) Group 2: ILMA (0.5‐1 mL) Duration of intervention: weekly 6‐10 weeks Duration of follow‐up: 6 months
Outcomes	Healing: complete improvement is defined as completely clinical re‐epithelialisation with no signs of induration and inflammation with negative smear for Leishman bodies at the end of the treatment period. Partial improvement is defined as the re‐epithelialising lesion has become smaller but not cured. If the lesion has become larger or has not been differed it will be called as no response to treatment. Time points reported: at 6 and 10 weeks of treatment and 6 months follow‐up
Notes	Study funding sources: not described Possible conflicts of interest: not described
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "This N randomised controlled clinical trail study with simple sampling." "72 patients randomly divided in two equal groups". Comment: insufficient detail was reported about the method used to generate the allocation sequence.
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not described
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Not described
Selective reporting (reporting bias)	Low risk	Comment: relevant outcomes were reported
Other bias	High risk	Sample size calculation and reporting of Leishmania spp involved was not correctly reported