| Methods |
Study design: randomised controlled trial Setting/location: Skin Disease and Leishmaniasis Research Center (SDLRC), Isfahan, Iran Study period: around 5 months Sample size calculation: not described |
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| Participants |
Type of Leishmania: not mentioned Inclusion criteria: CL confirmed with direct smear Exclusion criteria: pregnant or nursing mothers, treated previously for CL, any known intercurrent illness or a history of allergy to MA, palpebral lesions, having > 5 lesions, lesion > 3 cm, duration of lesions was > 12 weeks N randomised: 80: 40 in each group Withdrawals: 7 N assessed: 73: 38 in group 1 and 35 in group 2 Age: range 5‐75 years Baseline data: the most common clinical type of the lesions in both groups was papule (50% in TCA and 44% in the ILMA group) and nodule (25% in TCA and 24% in the ILMA group). Mean number of lesions: TCA: 1.2; ILMA: 1.4 |
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| Interventions |
Type of interventions:
Duration of intervention: up to 6 weeks |
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| Outcomes |
Healing: complete cure was defined as complete healing and re‐epithelialisation of the lesion(s); partial care as partial clinical improvement with reduction in erythema, induration and size of the lesions; treatment failure as the absence of any change or worsening of the lesion(s) Duration of remission and percentage of people with treated lesions that recur after 3 months of follow‐up Adverse effects Microbiological or histopathological cure of skin lesions Time points reported: after the last treatment session, 1 and 3 months post‐treatment. Complete cure was reported at 4 and 6 weeks of the treatment period. Recurrence was assessed at 3 months follow‐up |
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| Notes |
Study funding sources: not reported Possible conflicts of interest: none declared |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random digit table |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Unblindness is a limitation of this study" |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "For 80 patients, which participated in the study, 73 cases completed the study" Comment: the results for the dropouts were excluded from the statistical analysis. 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 | High risk | Sample size calculation and reporting of Leishmania spp involved was not correctly reported |