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. 2017 Nov 17;2017(11):CD005067. doi: 10.1002/14651858.CD005067.pub4
Methods Study design: prospective randomised controlled trial
Setting/location: Central Research Center of Skin Diseases and Leishmaniasis and Novin Laser Center; Isfahan, Iran
Study period: June 2010 to September 2011 (15 months)
Sample size calculation: sample size was calculated as 60 cases in each group with further rate of 10% dropouts and exclusions
Participants Type of Leishmania: not described
Inclusion criteria: leishmaniasis scar diagnosed clinically on participants by a dermatologist
Exclusion criteria: pregnancy, lactation, colloid scar, treatment with immune system inhibitors,
use of isotretinoin or fillers for the past 6 months, use of dermabrasion or skin resurfacing for the past 12 months, skin types of IV to V1
N randomised: 120 (60 people in case group and 60 in control group)
Withdrawals: not described
N assessed: not described
Mean (SD) age: 27.21 years (11.52) (range 6‐45)
Sex (male/female): 51%/49%
Baseline imbalances: none
Severity of illness: mean (SD) scar size: laser CO₂ group: 2.3 cm (0.3) and fractional CO₂ laser: 3.4 cm (0.4)
Interventions Type of interventions:
  • Group 1: ablative CO₂ laser after applying the topical anaesthetic on scar site with pulsed CO₂, duration: 10 ns, frequency: use of 20 kHz, and power: 25 Kw for one session. The participants were visited at the beginning of the treatment and after 3 and 6 months. Final evaluation was done in the 6th month.


  • Group 2: fractional laser in each session by energy: 25, one pulse, pass: 1, dot cycle: 6, with the system of Qray FRX, Dosis M and M

Outcomes Clinical response, according to standard quartile grading:
  • 0 < 25% (mild improvement)

  • 25% < score 1 < 50% (moderate improvement)

  • 50% < score 2 < 75% (good improvement)

  • < 75% (very good improvement)


The quantitative 4‐point scale used included:
  • 0 = unchanged size

  • 1 = the scar size became a bit small

  • 2 = the scar size became very small

  • 3 = the scar is almost removed


Time points reported: 6 months
Notes Study funding sources: Isfahan University of Medical Sciences
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 Not reported
Blinding of participants and personnel (performance bias) All outcomes High risk Open trial
Blinding of outcome assessment (detection bias) All outcomes Low risk Quotes: "A photo was taken from patients before and after treatment with a digital camera ... Evaluation of participants were done by 2 physicians who were not aware of the treatment group. These 2 physicians did the evaluations separately. The reduction in this size of ulcer and the scar was compared with the same lesion"
Incomplete outcome data (attrition bias) All outcomes Unclear risk Not reported
Selective reporting (reporting bias) Unclear risk Protocol not available
Other bias Unclear risk There was not enough information in the publication to assess if there were other biases present.