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. 2017 Nov 17;2017(11):CD005067. doi: 10.1002/14651858.CD005067.pub4
Methods Study design: randomised controlled trial
Setting/location: Dermatology Clinic of Faghihi Hospital, Shiraz University of Medical Sciences, Shiraz, Iran
Study period: unclear
Sample size calculation: not reported
Participants Type of Leishmania: not reported
Inclusion criteria: participant with CL confirmed
Exclusion criteria: not described
N randomised: 60
Withdrawals: 0
N assessed: 60 participants distributed into the 3 groups of equal number (n = 20)
Age: not reported
Sex: not reported
Baseline data: lesions were located on the head, neck and lower and upper extremities. Lesion duration was divided in 2 groups: a duration of < 3 months and > 3 months. Regarding lesion size, the authors divided the sizes in 3 groups: < 1 cm, 1‐3 cm and > 3 cm.
Interventions Type of interventions:
  • Group 1: cryotherapy. The freezing time was 10‐30 s with a thawing interval of 20 s

  • Group 2: cryotherapy + ILMA. The participants first received cryotherapy and after 5‐10 min were given ILMA

  • Group 3: ILMA. The solution was injected into each lesion (0.2 to 1.5 cm³ per session per week, depending on the size)


Duration of intervention: weekly for a total of 6‐8 times for each case
Outcomes Healing rates: percentage of participants 'cured': timing not reported
Adverse effects
Time points reported: not reported
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) Unclear risk 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 High risk The outcome is likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) All outcomes Unclear risk No blinding of outcome assessment, and the outcome measurement is likely to be influenced by lack of blinding.
Incomplete outcome data (attrition bias) All outcomes High risk No explanation was provided for missing outcome data.
Selective reporting (reporting bias) Low risk The study protocol is not available, but it is clear that the published reports included all expected outcomes, including those that were pre‐specified.
Other bias High risk Sample size calculation, reporting of Leishmania spp involved and baseline comparability were not correctly reported