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. 2017 Nov 17;2017(11):CD005067. doi: 10.1002/14651858.CD005067.pub4
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
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
Interventions Type of interventions:
  • Group 1: TCA 50% (wt/vol) was applied on the lesions every 2 weeks up to 3 times

  • Group 2: ILMA weekly up to 6 weeks


Duration of intervention: up to 6 weeks
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
Notes Study funding sources: not reported
Possible conflicts of interest: none declared
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