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. 2017 Nov 17;2017(11):CD005067. doi: 10.1002/14651858.CD005067.pub4
Methods Study design: randomised controlled trial
Setting/location: India
Study period: not described
Sample size calculation: not described
Participants Type of Leishmania: L tropica in the area
Inclusion criteria: participants with localised CL and only smear positive cases
Exclusion criteria: not being smear positive
N randomised: 60, 20 in each group
Withdrawals: 0
N assessed: 60 (100%), 20 in each group
Age (years): ≥ 15 years
Sex: not described
Severity of illness: 8, 11, and 12 participants had multiple lesions in the itraconazole, dapsone and placebo groups respectively.
Interventions Type of interventions:
  • Group 1: itraconazole 4 mg/kg/d (max. 200 mg)

  • Group 2: dapsone 4 mg/kg in 2 doses/d

  • Group 3: placebo control group


Duration of intervention: 6 weeks
Duration of follow‐up: 6 weeks, but 3 months for assessment of relapses
Outcomes Healing rates: percentage of participants 'cured' at the end of treatment. Strict clinical and parasitological criteria were followed to asses cure.
Adverse effects
Time points reported: healing rates 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 Not described
Allocation concealment (selection bias) Unclear risk Not described
Blinding of participants and personnel (performance bias) All outcomes Unclear risk Not described
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Not described
Incomplete outcome data (attrition bias) All outcomes Unclear risk Not described
Selective reporting (reporting bias) Low risk Relevant outcomes were reported
Other bias High risk Sample size calculation and reporting of Leishmania spp involved was not correctly reported