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IRCT20230613058476N1 IRCT 2023-07-30 Iran University of Medical Sciences Efficacy of pentoxifylline in CO2 laser treatment of burn scars 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 2020-06-21 anticipated 22 Complete https://irct.ir/trial/71200 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: -, Randomization description: 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), Blinding description: 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. 3 Burn Scar. Intervention 1: Intervention group: CO2 laser + Oral pentoxifylline. Intervention 2: Control group: CO2 laser. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Sarah Dilmaghani
Dermatology Department, Rasoul-e-akram hospital, Niyayesh St ,Sattarkhan Ave,
Tehran Iran (Islamic Republic of) 14535 +98 912 123 2647 sarah.dilmaghani@yahoo.com Iran University of Medical Sciences scientific Sarah Dilmaghani
Dermatology Department, Rasoul-e-Akram Hospital, Niyayesh St ,Sattarkhan St
Tehran Iran (Islamic Republic of) 1313114456 +98 912 123 2647 sarah.dilmaghani@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients between 18-50 years of age Having burn scars with the Vancouver Scar Scale of 5-12 18 years 50 years Both Evidence of wound infection associated collagen vascular disorders history of other chronic cutaneous diseases scars less than six months old recent treatment with corticosteroids, chemo- or radiotherapy T95 Sequelae of burns, corrosions and frostbite Treatment - Other Treatment - Devices Intervention group: CO2 laser + Oral pentoxifylline Control group: CO2 laser Improvement of burn scar. Timepoint: ‌Before treatment, one and two months after the start of the laser sessions, and three months after the completion of therapy. Method of measurement: modified Vancouver Scar Scale (VSS). Satisfaction of patients. Timepoint: ‌Before treatment, one and two months after the start of the laser sessions, and three months after the completion of therapy. Method of measurement: Visual Analoge Scale (1-3). Iran University of Medical Sciences Approved 2020-05-23 Ethic committee of Iran University of medical sciences Iran University of medical Sciences, Junction of Shahid Hemmat & Shahid Chamran Expressways, Tehran, Tehran Tehran Iran (Islamic Republic of)