Faghihi 2003

Methods	Study design: randomised controlled trial Setting/location: Isfahan, Iran Study period: 15 months Sample size calculation: yes
Participants	Type of Leishmania: L major is endemic in Isfahan Inclusion criteria: clinical and parasitological diagnosis of CL Exclusion criteria: pregnant or had > 3 lesions, ulcerative lesions, lesions with cartilage or lymphatic involvement or hypersensitivity to the drug N randomised: 96 participants, 48 in each group Withdrawals: 0 N assessed (lesions): 96 (190). 48 (95) in each group Age (years): age range 1‐48 years (mean age of 16 years old and a median of 14.5 years) Sex: male/female: 40/56 Baseline data: all lesions treated were papules or early nodules with mean diameter of about 4 mm. Mean number of lesions per person in each group: 1
Interventions	Type of interventions: Group 1: 15% PR sulphate and 10% urea in Eucerin ointment, applied twice daily at 1 mm thickness over the total surface of the lesion(s) Group 2: ILMA injections of 1.5 g/5 mL (maximum 12), weekly. The mean amount of solution required for each lesion was 0.2 mL to 0.8 mL. Duration of intervention: treatment was continued in both groups for 3 months or until complete recovery (return to the normal tissue texture without any atrophic changes or scar formation) Duration of follow‐up: one year
Outcomes	Primary outcome: percentage of participants 'cured' within 2 months after treatment. Complete recovery or cure was defined as re‐epithelialisation and return to normal tissue texture in less than 2 months, with no residual scar or relapse after follow‐up of up to 1 year Secondary outcomes: duration of remission and percentage of people with treated lesions that recur within one year; prevention of scarring Time points reported: completely recovered (cured) (< 2 months). Healed (in 2–3 months)
Notes	Study funding sources: Isfahan University of Medical Sciences (Pharmacy College and its Research Laboratory) and the Amin Leishmaniasis Research Group in Isfahan City Possible conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "In the period of recruitment, […] they were randomised by fixed block random allocation".
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	High risk	Treatment description do not appear as blinded
Blinding of outcome assessment (detection bias) All outcomes	High risk	In statistical methods section, quote "There was no blinding method used."
Incomplete outcome data (attrition bias) All outcomes	Low risk	No missing outcome data
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.