Iraji 2005

Methods	Study design: randomised controlled trial Setting/location: Iran Study period: not described Sample size calculation: the required sample size, 40 in each treatment group, was estimated, assuming one in every 4 cases would not provide full data, using the formula n = [Z1 − (a/2) + Z1 − b] 2 × [P1(1 − P1) + P2(1 − P2)]/(P1 − P2)2, and setting P1 (the paromomycin efficacy) to 0.7, P2 (the vehicle efficacy) to 0.3, a to 0.05, b to 0.1, Z1 − (a/2) to 1.96, and Z(1 − b) to 1.64
Participants	Type of Leishmania: L tropica and L major are responsible for hyperendemic CL in rural areas and endemic CL in parts of many cities in Iran Inclusion criteria: had the clinical signs of CL and all of their cutaneous lesions were found smear‐positive for amastigotes Exclusion criteria: cases who had first noticed a skin lesion > 3 months previously, had lesions on their face, had lesions with diameter of > 3 cm, had received previous treatment, or who were lactating or pregnant N randomised: 80, 40 in each group Withdrawals: 15. Intervention group: 10; control group: 5 N assessed: 65. Intervention group: 30; control group: 35 Age: range 8‐55 years. Mean intervention group: 21.4 years; control group: 21.5 years Sex (male/female): 33/32. Intervention group: 19/11; control group: 14/21 Baseline data: mean duration of lesions (years): intervention group: 1.65; control group: 1.75
Interventions	Type of interventions: Group 1: PR sulphate 15% + 10% urea applied to a 1 mm‐thick layer twice daily Group 2: vehicle control group (Eucerin containing 10% urea) applied topically twice daily Duration of intervention: 30 days Duration of follow‐up: for clinical and parasitological follow‐up on day 30 and for only parasitological follow‐up on day 60
Outcomes	Healing rates: percentage of participants 'cured' one month after treatment, clinical and parasitological cure Complete healing was defined as a reduction in the size and induration of the lesion(s) by at least 75% and lesion smears that appeared amastigote‐free Partial cure was defined as a reduction in the size and induration of the lesion(s) by > 25% but < 75%, and lesion smears that appeared amastigote‐free. Failure was defined as a reduction in the size and induration of the lesion(s) by < 25% and/or an amastigote‐positive smear Adverse effects Time points reported: days 30 (clinical and parasitological follow‐up) and 60 (parasitological follow‐up)
Notes	Study funding sources: not reported Possible conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "The cases enrolled were assigned to two treatment groups, placebo or paromomycin, using computer‐based randomisation."
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Study was described as "double blind" but no description about allocation method was given.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No blinding of outcome assessment described
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No data about dropouts were given
Selective reporting (reporting bias)	Low risk	Relevant outcomes were reported
Other bias	Unclear risk	There was not enough information in the publication to assess if there were other biases present.