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IRCT20190901044666N4 IRCT 2023-01-18 Iran University of Medical Sciences Effect of fractional CO2 laser in combination with 5-fluorouracil cream compared to PDL laser in the treatment of hypertrophic and keloidal scars Evaluation of the efficacy of fractional CO2 laser in combination with 5-fluorouracil cream compared to PDL laser in the treatment of hypertrophic and keloidal scars: A randomized controlled clinical trial 2023-01-17 anticipated 24 Complete https://irct.ir/trial/67481 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the simple randomization method, the patients who refer to the laser clinic of Hazrat Fatemeh Hospital are placed in 2 groups in such a way that one envelope is randomly selected for each patient from the number of 24 sealed envelopes. Inside each envelope is the letter A or B. Group A patients will be treated with PDL laser and group B patients will be treated with fractional CO2 laser in combination with 5FU cream, Blinding description: Due to the clear difference between the mentioned therapeutic interventions, it was not possible to blind the therapist and the patients, and as a result, the study will be conducted in a one-sided blind manner. In other words, the evaluation of the results of the studies will be done by an evaluator who is blind to the type of intervention (a dermatologist who does not know which treatment group the patient is in) and based on the images taken of the lesions in each session. Also, data analysis will be done by a blinded statistician. 3 Hypertrophic scar. Intervention 1: Intervention group: Fractional CO2 laser treatment in combination with 5FU cream: Before the intervention, gentle cleaning of the desired lesion will be done using gauze soaked in normal saline. Then 60 minutes before the laser treatment, local anesthetic cream containing 2.5% lidocaine and 2.5% prilocaine (Xyla-P, Tehran Chemie, Tehran, Iran) will be applied on the lesion. At the end of 60 minutes, the local anesthetic cream will be removed using alcohol cotton. Then fractional CO2 laser will be applied using Deka SmartXide DOT (Deka, Florence, Italy) laser device (with power 14, stack 2, space 600 and dwell time 600) in each lesion area of 5x5 cm2. Immediately after laser treatment, five percent 5FU cream is used in the lasered area and this treatment will continue twice a day for 5 days. Intervention 2: Control group: PDL laser treatment:Before the intervention, gentle cleaning of the desired lesion will be done using gauze soaked in normal saline. Then PDL laser using Deka Alexandrite laser device (Synchro VasQ, Deka, Florence, Italy) with spot size of 7 mm, single duration of 0.5 milliseconds and power of 7 J/cm2 with 50 shots per 5x5 lesion area Square centimeters will apply. 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 Afsaneh Sadeghzadeh bazargan
Hazrate Rasoole Akram Hospital,Niayesh St,Satarkhan Av, Tehran
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2421 sadeghzadeh.a@iums.ac.ir Iran University of Medical Sciences scientific Afsaneh Sadeghzadeh bazargan
Hazrate Rasoole Akram Hospital,Niayesh St,Satarkhan Av, Tehran
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2421 sadeghzadeh.a@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years old Patients with a confirmed diagnosis of erythematous hypertrophic scar in the number of at least 2 The size of the waste should be at least 5x5 cm square or have a length of at least 5 cm The patient is not pregnant or breastfeeding During the last two months, the patient has not received any treatment for the lesions, including laser treatment, topical or injectable corticosteroids The patient has no underlying diseases that lead to scar healing process; such as diabetes or weakened immune system The patient's cooperation in carrying out therapeutic interventions and referring for all therapeutic sessions 18 years no limit Both L91.0 Hypertrophic scar Treatment - Drugs Treatment - Devices Intervention group: Fractional CO2 laser treatment in combination with 5FU cream: Before the intervention, gentle cleaning of the desired lesion will be done using gauze soaked in normal saline. Then 60 minutes before the laser treatment, local anesthetic cream containing 2.5% lidocaine and 2.5% prilocaine (Xyla-P, Tehran Chemie, Tehran, Iran) will be applied on the lesion. At the end of 60 minutes, the local anesthetic cream will be removed using alcohol cotton. Then fractional CO2 laser will be applied using Deka SmartXide DOT (Deka, Florence, Italy) laser device (with power 14, stack 2, space 600 and dwell time 600) in each lesion area of 5x5 cm2. Immediately after laser treatment, five percent 5FU cream is used in the lasered area and this treatment will continue twice a day for 5 days. Control group: PDL laser treatment:Before the intervention, gentle cleaning of the desired lesion will be done using gauze soaked in normal saline. Then PDL laser using Deka Alexandrite laser device (Synchro VasQ, Deka, Florence, Italy) with spot size of 7 mm, single duration of 0.5 milliseconds and power of 7 J/cm2 with 50 shots per 5x5 lesion area Square centimeters will apply. Effectiveness of treatment on scar. Timepoint: Scar score measurement at the beginning of the study (before the start of the intervention) and after the end of the third session of the intervention (3 months later). Method of measurement: Vancouver scar scale (VSS) scoring method will be used to check the effectiveness of the treatment. This scale includes examination of 4 characteristics of the lesion, including: vascularity, pigmentation, height and flexibility, which are scored for each characteristic and the sum of all points will be checked in order to evaluate the improvement of the lesion. Iran University of Medical Sciences Approved 2022-11-23 Ethics committee of Iran University of Medical Sciences Rasoul Akram Hospital, At the corner of Mansouri St, Niayesh St, Satarkhan St Tehran Tehran Iran (Islamic Republic of)