Shazad 2005

Methods	Study design: randomised controlled trial Setting/location: Military Base Clinic, Iran Study period: January to October 2001 (10 months) Sample size calculation: not described
Participants	Type of Leishmania: L major Inclusion criteria: proven cases of CL, healthy apart from CL, lesions not in close proximity to a vital organ or joint, number of lesions 1 to 3, ulcer size < 5 cm in diameter, onset of the lesions < 3 months, no previous standard anti‐Leishmania treatment, no history of allergy to the paromomycin family Exclusion criteria: not reported N randomised: 60, 30 in each group Withdrawals: 4. Group 1: 1; group 2: 3, N assessed: 36. Group 1: 29; group 2: 27 Age: Group 1: approx 20.6 years; group 2: approx 21.7 years Sex: all men Baseline data: Group 1: 76.7% had ulcerative, 8.3% nodular, and 15% papular type of lesions, and they were primarily located in the head and neck (25%), upper extremities (41.7%), lower extremities (31.7%) and trunk (1.7%). MNL: 2. MSL 21.7 mm. MDLBT: 37.8 days Group 2: 69.7% had ulcerative, 11.8% nodule, and 18.4% papule type of lesions, and they were primarily located in the head and neck (13.2%), upper extremities (47.4%), lower extremities (36.8%) and trunk (2.6%). MNL: 2.4. MSL: 25 mm. MDLBT: 39 days
Interventions	Type of interventions: Group 1: 15% PR sulphate and 10% urea. Dose: 0.5 mg/mm²/d Group 2: intradermal MA every other day Duration of intervention: 20 days
Outcomes	Healing rates: Complete cure was defined as complete re‐epithelialisation of all lesions at one week after cessation of treatment. Participants with multiple lesions were considered to be cured if all the lesions were healed. Partial cure (parasitological cure) was defined when clinical cure had not occurred in any lesion in a participant but no L amastigote was found in a direct smear of the lesions(s), 3 slides were prepared, and stained from each active ulcer, and 1000 fields were checked (approximately 3 slides). Failure of treatment was defined as no clinical cure and no parasitological cure at one week after cessation of treatment; relapse was defined as a reappearance of the lesion after complete cure. Adverse effects Time points reported: follow‐up and clinical evaluation were performed at week 1 and 6 after completion of treatment. Participants were visited once at 6 months after treatment was completed.
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	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	High risk	Study was described as open and no blinding was done
Blinding of outcome assessment (detection bias) All outcomes	High risk	Study was described as open and no blinding was done
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: relevant outcomes were reported
Selective reporting (reporting bias)	Low risk	Comment: relevant outcomes were reported
Other bias	Unclear risk	There was not enough information in the publication to assess if there were other biases present.