| Methods |
Study design: randomised controlled trial Setting/location: India Study period: not described Sample size calculation: not described |
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| 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. |
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| Interventions |
Type of interventions:
Duration of intervention: 6 weeks Duration of follow‐up: 6 weeks, but 3 months for assessment of relapses |
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| 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 |
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| Notes |
Study funding sources: none 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) | 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 |