Asilian 2004b

Methods	Study design: randomised controlled trial Setting/location: Skin and Leishmaniasis Research Center of Isfahan (Iran) Study period: not described Sample size calculation: not described
Participants	Type of Leishmania: not reported Inclusion criteria: age 7‐70 years, disease confirmed clinically and by laboratory methods, lesions present, surface area of lesions ≤ 5 cm² Exclusion criteria: disease duration > 4 months; pregnant or breastfeeding; chronic disease; immune suppression; and sporotrichoid forms N participants randomised (lesions): 233 (433). 123 (183) were included in the CO₂ laser group and 110 (250) in the IMMA group Withdrawals: 59 (112). CO₂ laser group: 40 (72), IMMA group: 19 (40) N assessed (lesions): 174 (321). CO₂ laser group: 83 (111), IMMA group: 91 (210) Age: range 12‐60 years Sex (male/female): 55/68 included in the CO₂ laser group; 40/70 in the IMMA group (control group) Baseline imbalances: no Severity Illness: in 47% of cases, participants had one lesion and in 53% of cases they had 2‐5 lesions. There were more lesions on the upper limbs (43%), and lesions were < 5 cm². In the remaining, the lesion duration was 2‐4 months. Mean number of lesions: CO₂ laser group: 1.49; IMMA group: 2.27
Interventions	Type of interventions: Group 1: CO₂ laser (30 W, continuous) was applied to the lesion and an area 2‐3 mm around it. This procedure was repeated until the ulcer bed turned brown. After completion of the procedure, the ulcer was covered with 2% erythromycin ointment. Group 2: IMMA 50 mg/kg/d for 15 days and after 15 days of rest, this treatment was repeated. Co‐interventions: in the first group, lesions were locally anaesthetised by injection of 1%–2% lidocaine Duration of follow‐up: 24 weeks
Outcomes	Healing rates: Percentage of lesions 'cured' 1.5 months after treatment Speed of healing (time taken to be 'cured') Prevention of scarring Adverse effects
Notes	Study funding sources: none declared Possible conflicts of interest: none described
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: the author was contacted. The randomisation was through coin flip method.
Allocation concealment (selection bias)	Unclear risk	Comment: the author was contacted. The randomisation was through coin flip method, but the method to conceal the allocation was not described.
Blinding of participants and personnel (performance bias) All outcomes	High risk	No data provided, but the treatment is unlikely to be blinded
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information provided about blinding of outcome assessment
Incomplete outcome data (attrition bias) All outcomes	High risk	Imbalance in the missing data between the groups
Selective reporting (reporting bias)	Low risk	The study protocol is not available, but it is clear that the published reports include all expected outcomes, including those that were pre‐specified.
Other bias	Unclear risk	Sample size calculation and reporting of Leishmania spp involved was not correctly reported