Asilian 2003a IRN.

Methods	Trial design: Doubled‐blind, placebo‐controlled RCT. Unit of randomization: A soldier. Number of participants: 324 male soldiers (162 each group). Entomological data collection: Not performed. Clinical data collection: All soldiers were visited monthly. CL diagnosis was confirmed in every suspected lesion parasitologically using Giemsa‐stained direct smears. If amastigotes were not seen, the lesion was biopsied. Follow‐up: 6 months. Analysis: Analysed at individual level.
Participants	Male soldiers, aged 19 to 21 years, with no history of leishmaniasis or any evidence of active CL. Endemic disease: CL (no mention of theLeishmania species involved).
Interventions	Permethrin‐impregnated uniforms (shirt, undershirt, pants, socks and hat; with a permethrin concentration of 850 mg/m² of clothing), for 3 months. Control uniforms (shirt, undershirt, pants, socks and hat were soaked in water that did not contain permethrin), for 3 months.
Outcomes	Number of new cases of leishmania, assessed at 6 months. Adverse‐effects, such as contact dermatitis, were not observed in any soldiers.
Notes	Country: Iran (area of Isfahan). Trial dates: June 2001 to September 2001. Trial sponsor: Not reported. Sample size calculation: Not calculated. Compliance assessment: Done. Soldiers were instructed not to use insect repellents and other protective measures, and adherence to these instructions was monitored. The uniforms covered the whole body except for the head, neck, hands and feet.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient detail was reported about the method used to generate the allocation sequence. "A total of 324 soldiers were randomly divided into two groups".
Allocation concealment (selection bias)	High risk	Not reported.
Blinding (performance bias and detection bias) participants	Unclear risk	Participants were blinded but with no detail of the method used for it. "The uniforms were distributed in such a way that neither the soldier nor the researcher knew as to which uniform were permethrin‐impregnated".
Blinding (performance bias and detection bias) investigators	Unclear risk	Investigators were blinded but with no detail of the method used for it. "The uniforms were distributed in such a way that neither the soldier nor the researcher knew as to which uniform were permethrin‐impregnated".
Blinding (performance bias and detection bias) Assessors	Unclear risk	Not reported.
Incomplete outcome data (attrition bias) All outcomes	High risk	ITT analysis was not used. Intervention: 28 dropouts (the reasons for dropouts were not reported). Control: 24 dropouts (the reasons for dropouts were not reported).
Selective reporting (reporting bias)	Low risk	All outcomes mentioned in the methods were reported in the results.
Baseline measurements	High risk	No baseline characteristics by group.
Statistical adjustment for clustering	Low risk	Not applicable as this trial was individually randomized.
Other bias	Unclear risk	Trial authors did not provide a conflict of interest declaration. They did not take into account the activities of soldiers during day and night, or where they slept.