The effect of pentoxifylline in the efficacy, safety, and tolerability of, and treatment satisfaction with, Carbon dioxide laser in patients with burn scars : A blinded randomized controlled trial

Evaluating oral pentoxifylline in the efficacy, safety, tolerability ,treatment satisfaction of Carbon dioxide laser in patients with burn scars

Parallel group, randomized, blinded (assessor and analyst), phase 3 RCT on 44 burn scar patient. Randomization by random generation of SPSS software.

one group underwent three sessions of CO2 laser (DEKA SmartXide 2016, Italy) power 12 Watts; stacking 2; spacing, 800 µm, dwell time 800 µsec, at 45-day intervals and the other group received the same CO2 laser treatment protocol plus pentoxifylline 400 mg twice daily for four months.

Patients between 18-50 years of age with burn scars, with the Vancouver Scar Scale of 5-12. Patients with wound infection, associated collagen vascular disorders, or chronic cutaneous diseases, scars were less than six months old or history of previous treatment with corticosteroids, chemo- or radiotherapy were excluded from the study.

one group (control) underwent three sessions of CO2 laser at 45-day intervals and the other group (treatment) received the same CO2 laser treatment protocol plus pentoxifylline 400 mg twice daily for four months.

Improvement of VSS score Tolerability of treatment Adverse events Patients' satisfaction

To randomize the patients in this study, the stratified block randomization method was used by R software. To ensure balance between the two groups, stratification parameters including age and sex were selected. According to the age range of the patients, which was 18-50 years, two subgroups of 18 to 30 years (young) and 30 to 50 years (middle-aged) and for gender, male or female were selected as stratification subgroups, and finally the samples were divided into four strata, young men - middle-aged men - young women - middle-aged women. Then, according to the size of each block, the randomization function was used to assign patients to two groups, group A (Co2 laser + pentoxifylline) or group B (CO2 laser alone).

The physician evaluating treatment responses was blind to the patient’s treatment groups. Also, the data analyzer was blind to the groups. The care giver who provided oral treatment was the only person informed by the subjects grouping. The assessors (selected from blinded dermatology residents) who performed followups and completed questionnaires and data analyst (from outside the research group) were completely blinded on the subjects' allocations.