| 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 |
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| 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) |
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| Interventions |
Type of interventions:
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| Outcomes |
Clinical response, according to standard quartile grading:
The quantitative 4‐point scale used included:
Time points reported: 6 months |
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| Notes |
Study funding sources: Isfahan University of Medical Sciences 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 | 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. |