Momeni 1996

Methods	Study design: randomised controlled trial Setting/location: Iran Study period: not described Sample size calculation: assuming a 30% spontaneous cure rate with placebo and the minimum usefulness of a 60% cure rate with itraconazole, and a 10% dropout rate, the sample size was calculated as 70 individuals in each group
Participants	Type of Leishmania: L major Inclusion criteria: age > 12 years, diagnosis of CL confirmed by laboratory test results, no previous treatment for leishmaniasis, no serious concomitant medical problems Exclusion criteria: age < 12 years, pregnant and nursing women, patients who had lesions on the face, lesions lasting > 4 months N randomised: 140. Itraconazole: 70; placebo: 70 Withdrawals: itraconazole: 5 N assessed (lesions): 131. Itraconazole: 65 (219); placebo: 66 (262) Age: mean 26.3 years (range 12‐46) Sex (male/female): 90/41. Itraconazole: 44/21; placebo: 46/20 Baseline data: Number of lesions: itraconazole: 219; placebo: 262 Mean duration of lesions (SD): itraconazole: 38 days (1.45 months); placebo: 45 days (1.5 months)
Interventions	Type of interventions: Group 1: itraconazole orally 7 mg/kg/d (max. 400 mg per day) Group 2: placebo capsules Duration of intervention: 3 weeks Duration of follow‐up: 51 days
Outcomes	Healing rates: percentage of participants 'cured' 51 days after treatment Adverse effects Time points reported: at the end of treatment (day 21); on day 51 (1 month after the end of treatment)
Notes	Study funding sources: this work was supported by the World Health Organization Special Program for Research and Training in Tropical Diseases and the research programme of Isfahan University of the Medical Sciences. Possible conflicts of interest: not described
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Carried out by the WHO Special Programme for Research and Training in Tropical Diseases group in Geneva, Switzerland" Comment: insufficient detail was reported about the method used to generate the allocation sequence.
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgment
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Identical capsules containing 100 mg of itraconazole or placebo were used in the study. The 2 treatment groups received either itraconazole as coded capsules for 21 days or placebo as coded capsules with the same dosages. Review authors judge that the outcome is not likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information to permit judgment
Incomplete outcome data (attrition bias) All outcomes	Low risk	Reasons for missing outcome data unlikely 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, including those that were pre‐specified. The study published reports our primary outcomes: 'cured' and adverse effects
Other bias	Low risk	Other items assessed correctly reported