El‐Sayed 2010

Methods	Study design: randomised, prospective, double‐blind trial Setting/location: the Saudi Hospital in Sanaa, Yemen Study period: 21 months; participants recruited from June 2006 to June 2007 Sample size calculation: not described
Participants	Type of Leishmania: Leishmania spp Inclusion criteria: all had the clinical signs of cutaneous leishmaniasis and a majority of their cutaneous lesions were found smear positive for mastigotes. 4 participants with a negative smear preparation were diagnosed by tissue culture using NNN (Novey, McNeal and Nicolle) medium Exclusion criteria: skin lesions of more than 8 weeks duration, allergic to antimonial drugs, lactating or pregnant N participants randomised (lesions): N = 30: ILSSG, n = 10 participants (12 lesions), ILSSG + IMSSG, n = 10 (15), ILSSG + oral ketoconazole: n = 10 (13) Withdrawals: no N assessed: 30 (100%) Age: range 12‐50 years (mean 23.5, SD 14). Group 1: 12‐50 (24.3, SD 15); group 2: 13‐48 years (22.5, SD 14); group 3: 12‐49 years (25.1, SD 12) Sex (male/female): group 1, 5/5; group 2, 7/3; group 3, 4/6 Baseline data: Group 1: duration of disease (weeks) 2–5. Site: face 10, upper extremities: 2. Type of ulceration: nodules 5, plaques 7 Group 2: duration of disease (weeks) 3‐7. Site: face 14, upper extremities: 1. Type of ulceration: nodules 8, plaques 7 Group 3: duration of disease (weeks) 2–8. Site: face 12, upper extremities: 1. Type of ulceration: nodules 6, plaques 7
Interventions	Type of interventions: Group 1: ILSSG (100 mg/mL) alone, following a treatment schedule on alternate day's injection Group 2: ILSSG + IMSSG injections. A part of the dose (calculated as 20 mg/kg/d) was injected intralesionally on days 1, 3, 5 as in group 1. The remaining amount of the total dose was given intramuscularly simultaneously on the same day. Group 3: ILSSG as in group 1 + oral ketoconazole (200 mg 3 times daily) for 4 weeks Duration of intervention: in all groups, treatment was continued until clearance or for a maximum of 3 treatment cycles at 4 week intervals (12 weeks) Follow‐up: performed monthly for 6 months after the last treatment
Outcomes	Clinical cure: the cure was indicated by complete re‐epithelialisation, the disappearance of oedema, induration and other signs of inflammation and a negative Giemsa‐stained direct smear of a scraping of the skin at the lesion site. In the 4 participants diagnosed only by a positive culture before enrolment, the cure was indicated by a negative culture at the end of the 12 weeks. Adverse effects Time points reported: 4, 8, 13 weeks. Adverse effects: at the end of 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	Comment: insufficient detail was reported about the method used to generate the allocation sequence
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open trial
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "A follow‐up assessment was performed by the treating clinician, the patient and by comparing the serial photographs" Comment: open trial
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants completed the study
Selective reporting (reporting bias)	Low risk	All relevant outcomes were reported
Other bias	High risk	Sample size calculation and reporting of Leishmania spp involved was not correctly reported