Esfandiarpour 2002

Methods	Study design: randomised controlled trial Setting/location: Iran Study period: not described Sample size calculation: not described
Participants	Type of Leishmania: L tropica in the area Inclusion criteria: positive direct smear or documented skin biopsy, not pregnant or nursing at the time of therapy, no serious systemic illness, no sensitivity to antimonial drugs or AL Exclusion criteria: not having received treatment for at least 2 months before entry into the study. N randomised: 150. 50 in each group Withdrawals: 0 N assessed: 150 (100%). 50 in each group Age: mean age 14 years. Group 1 (AL): 14, group 2 (IMMA): 14.5, group 3 (AL + IMMA): 14 Sex: male/female: 69/81. 23/27 in each group Baseline data: the common sites of involvement were the face and extremities. By groups were as follows: oral AL: face: 62%; upper limbs: 34%; lower limbs: 4%, and trunk: nil. IMMA: face: 48%; upper limbs: 38%; lower limbs: 14%, and trunk: nil. AL + IMMA: face: 78%; upper limbs: 15%; lower limbs: 6%, and trunk: 2%. Most participants had plaque‐type, papular, and nodular lesions. By groups: AL: plaque: 64%, papule: 29%, and nodule: 7%. IMMA: plaque: 71%, papule: 18%, and nodule: 11%. AL + IMMA: plaque: 77%, papule: 19%, and nodule: 4%. Mean number of lesions: group 1, 1.5; group 2, 1.8; group 3, 1.4. Most had multiple lesions (≤ 7 lesions) Mean duration of lesions: group 1, 8 months; group 2, 7.4 months; group 3, 8 months
Interventions	Type of interventions: Group 1: AL orally 15 mg/kg/d for 3 weeks Group 2: IMMA 30 mg/kg/d for 2 weeks Group 3: AL + IMMA simultaneously Duration of follow‐up: one month
Outcomes	Primary outcome: percentage of participants 'cured' at the end of treatment. The response to treatment was graded as excellent (reduction in the size of the lesion by at least 80% or complete clearance), good (reduction in the size of the lesion by 50%), and poor (minimal or no change in the lesion) Secondary outcome: adverse effects Time points reported: end of treatment and 2 and 4 weeks later
Notes	Study funding sources: none reported Possible conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "the patients were randomly divided into three groups." Comment: insufficient detail was reported about the method used to generate the allocation sequence.
Allocation concealment (selection bias)	Unclear risk	Quote: "the patients were randomly divided into three groups." Comment: no further information provided
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: the treatment it is not possible to blind
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: no reference to the outcome assessment blinding
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: no missing outcome data
Selective reporting (reporting bias)	High risk	Comment: no reference to adverse effects
Other bias	High risk	Sample size calculation and reporting of Leishmania spp involved was not correctly reported