Momeni 2002

Methods	Study design: randomised controlled trial Setting/location: Skin Research Centre in Isfahan city. Iran Study period: not described Sample size calculation: not described
Participants	Type of Leishmania: L major Inclusion criteria: age > 5 years, diagnosis of CL confirmed by laboratory test results, no previous treatment for leishmaniasis, no serious concomitant medical problems, signed written informed consent Exclusion criteria: pregnant and nursing women, age < 5 years, lesions lasting for > 4 months N randomised: 72. Group 1: 36; group 2: 36 Withdrawals: 6, lost to follow‐up. Group 1: 5; group 2: 1 N participants assessed (lesions): 66 (196). Group 1: 31 (91); group 2: 35 (105) Mean age (male/female): 21.9 years/17.6 years (range 5‐48 years). Group 1: 23.6 years/17.4 years; group 2: 20.2 years /18.1 years Sex (male/female): 50 (75.7%)/16 (24.3%). Group 1: 26/5; group 2: 24/11 Baseline data: Number of lesions: group 1: 91; group 2: 105 Mean duration of lesions (SD): group 1: 46.7 days (1.67 months); group 2: 45 days (1.58 months)
Interventions	Type of interventions: Group 1: AL 20 mg/kg per day + low‐dose IMMA 30 mg/kg/d for 20 days Group 2: IMMA 60 mg/kg/d for 20 days Duration of intervention: 20 days Duration of follow‐up: 51 days (1 month after the end of treatment)
Outcomes	Healing rates: percentage of participants 'cured' 51 days after treatment. On day 21 (end of therapy), the clinical response to treatment was coded subjectively as: apparent cure, partial response, and failure. After 1 month of follow‐up (day 51), the participants were described as showing definitive cure if all the lesions had healed and direct smears of the lesions were negative Adverse effects Tertiary outcomes: microbiological or histopathological cure of skin lesions Time points reported: day 21, and 1 month after the end of treatment: day 51
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: "Seventy‐two patients were assigned randomly to two 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	High risk	Imbalance in numbers across intervention groups: 5/36 (13.89%), AL + IMMA group; 1/36 (2.78%), IMMAgroup. We think missing outcome data likely to be related to true outcome.
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	Unclear risk	There was not enough information in the publication to assess if there were other biases present.