Asilian 2014

Methods	Study design: randomised, prospective, clinical trial Setting/location: Skin and Leishmaniasis Research Center of Isfahan, Barkhar Health Center and Department of Dermatology, Isfahan University of Medical Sciences (Iran) Study period: not described Sample size calculation: not described
Participants	Type of Leishmania: not described Inclusion criteria: fewer than 4 lesions of < 1 month old and < 3 cm, lesions not located on the face, > 15 years of age, lesions located neither on muscles nor were sporotrichoid lesions; receiving no medication for leishmaniasis Exclusion criteria: history of susceptibility to MA or miltefosine; pregnant or breastfeeding; immunosuppressed; had taken systemic medication interfering with p‐450 enzyme; or history of kidney, liver, and heart failure N randomised: 64. Topical miltefosine: 32, ILMA: 32 Withdrawals: 0 N assessed: 64 (100%). Topical miltefosine: 32, ILMA: 32 Mean age (SD): 23.12 years (13.30) Sex: topical miltefosine: 17 males (53%) and 15 females (47%). ILMA: 16 males (50%) and 16 females (50%) Baseline data: mean (SD) size of the lesions before treatment in the group treated with miltefosine and ILMA was 4.4 cm (3.1) and 2.3 cm (2.2), respectively.
Interventions	Type of interventions: Group 1: topical miltefosine (ointment 6%), once daily (28 days) in a way that the lesion was completely smeared with the ointment Group 2: ILMA, twice a week (up to 28 days) Duration of intervention: 28 days
Outcomes	Clinical cure: cure of cutaneous leishmaniasis was defined as follows: Complete cure: the lesion was flat, no induration observed, epidermal crease observed. Partial cure: reduction in size of the lesions, but no epidermal creases observed. Uncured: clinically no reduction observed in the lesion size or even an increase in the lesion size observed. Adverse effects: participants were questioned about expected adverse effects for 3 days (days 5–7) following administration of the doses. These were considered drug‐related if they were not reported at presentation. Time points reported: at the end of treatment, 1 month after treatment
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 two groups" 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	Open trial
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Open trials. Photography was done from all the lesions both at the first visit and all the follow‐up visits
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts
Selective reporting (reporting bias)	High risk	Protocol not available; not registered; in clinical trial registry; adverse effects not reported
Other bias	High risk	Sample size calculation and reporting of Leishmania spp involved was not correctly reported