Özgöztasi 1997

Methods	Study design: randomised controlled trial Setting/location: Turkey Study period: around 8 weeks Sample size calculation: not described
Participants	Type of Leishmania: Leishmania spp: L tropica in the area Inclusion criteria: confirmed diagnosis of CL Exclusion criteria: pregnant, nursing, or serious concomitant diseases N randomised: 72 Withdrawals: 0 N assessed: 72 (100%): 40 participants in group 1 and 32 participants in group 2 Age: most were children aged 10 years or younger Sex: both sexes Baseline data: the most common site of the lesion was the face and most of the participants had one papulonodular lesion, with duration of the lesions varying from 1 to 12 months Group 1: MNL: 1. MDLBT: 4.3 months Group 2: MNL: 1. MDLBT: 4.3 months
Interventions	Type of interventions: Group 1: 15% PR sulphate + 12% MBCL twice daily for 15 days Group 2: ketoconazole orally 400 mg per day for 30 days (reduced to 200 mg if participants < 12 years old) Duration of intervention: 4 weeks
Outcomes	Healing rates: percentage of participants 'cured' one month after treatment Adverse effects Time points reported: at the end of treatment and 4 weeks post‐treatment
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)	Unclear risk	Quote: "Patients were divided randomly into two treatment 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	High risk	Quote: "An open‐labeled, N randomised controlled trial to evaluate the efficacy of paromomycin ointment as compared with ketoconazole" Comment: we think the outcome is likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "No subjects withdrew because of this adverse effect" Comment: no dropouts, so ITT analyses were performed.
Selective reporting (reporting bias)	Low risk	The study protocol is not available, but it is clear that the published reports include all expected outcomes.
Other bias	High risk	Sample size calculation and reporting of Leishmania spp involved was not correctly reported

ACL: anthroponotic cutaneous leishmaniasis; AL: allopurinol; CCR: complete clinical response; CL: cutaneous leishmaniasis; HF‐EC: high frequency electrocauterisation; HSCS: hypertonic sodium chloride solution; IL: intralesional; ILMA: intralesional meglumine antimoniate; ILSSG: intralesional sodium stibogluconate; IM: intramuscular; IMMA: intramuscular meglumine antimoniate; IQR: interquartile range; IV: intravenous; MA: meglumine antimoniate; MBCL: methyl benzethonium chloride; MDLBT: median duration of lesions before therapy; MNL: median number of lesions; MSL: median size of lesions; MWT: moist wound treatment; PDT: topical photodynamic therapy; PR: paromomycin; RF: radiofrequency; RFHT: radiofrequency heat therapy; SD: standard deviation, SEM: standard error of the mean; SSG: sodium stibogluconate; TCA: trichloroacetic acid; TM: ThermoMed; ZS: zinc sulphate;