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IRCT20150825023753N23 IRCT 2024-01-17 Shiraz University of Medical Sciences Comparison of fractional co2 laser therapy alone and with its combination with topical timolol or topical insulin in the treatment of acne scar Comparison of fractional co2 laser therapy alone and with its combination with topical timolol or topical insulin in the treatment of acne scar, A randomized controlled clinical trial 2023-12-31 anticipated 30 Complete https://irct.ir/trial/60715 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization will follow a permuted block method, including 12 blocks of four, achieved by Random Allocation Software. In this regard, the lesions are divided into two groups A (right side of the face) and B (left side of the face). Dark-colored envelopes will be used to hide random allocation, Blinding description: The used drugs will be poured into similar containers that will be tagged for A and B so that the resident and the patient will be ignorant of the applied medication. Only the secretary of the dermatology department will know the medication of each group. 3 Acne scar. Intervention 1: Intervention group: Group A will receive fractional CO۲ laser therapy with distilled water on one side and the combination of fractional CO۲ laser therapy and topical Timolol Maleate ۰.۵% on the other side. The mode of the fractional CO۲ device will be set to: Power: ۱۲, Stack:۲, Scanning dwell time: ۷۰۰, and Spacing: ۷۰۰. Intervention 2: Intervention group: Group B will receive fractional CO۲ laser therapy with distilled water on one side and the combination of fractional CO۲ laser therapy and topical regular insulin on the other side. The mode of the fractional CO۲ device will be set to: Power: ۱۲, Stack:۲, Scanning dwell time: ۷۰۰, and Spacing: ۷۰۰. Yes - There is a plan to make this available What will be shared: Demographic data and the result of the clinical trial When: One year later To whom: Researchers Conditions: After the publication of the article based on the clinical trial, it will be possible to share the data. The recipients of the data can use the data by obtaining permission from the project managers. The managers of this project will allow the data to be used in secondary data analysis studies and systematic reviews. Where to obtain: Data requesters can submit their request by sending an email to each of the administrators that their names and emails have been entered into this system. How to obtain: Data requesters can submit their request by sending an email to each of the administrators that their names and emails have been entered into this system. Comments: Data requesters can submit their request by sending an email to each of the administrators that their names and emails have been entered into this system.
public Dr. Sara Sadat Alavizadeh
Zand Streat, Shahid Faghihi Hospital
Shiraz Iran (Islamic Republic of) 7134846114 009832125592 alavizadeh.sarah@gmail.com Shiraz University of Medical Sciences scientific Dr. Nasrin Saki
Zand Ave, Shahid Faghihi Hospital,
Shiraz Iran (Islamic Republic of) 7134846114 +98 71 3212 5592 nasrinsa85@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) The patients with moderate to severe atrophic acne scarring and no inflammatory lesions Age above 15 years old 15 years no limit Both Pregnant and lactating patients Patients who have inflammatory lesions Patients who have active Koebner-inducing diseases such as psoriasis and Lichen planus Patients who have Asthma, atrioventricular blocks, sinus bradycardia, diabetes mellitus Prior use of beta blockers, The patients who have received Isotretinoin in the past three months. L90.5 Scar conditions and fibrosis of skin Treatment - Drugs Treatment - Drugs Intervention group: Group A will receive fractional CO۲ laser therapy with distilled water on one side and the combination of fractional CO۲ laser therapy and topical Timolol Maleate ۰.۵% on the other side. The mode of the fractional CO۲ device will be set to: Power: ۱۲, Stack:۲, Scanning dwell time: ۷۰۰, and Spacing: ۷۰۰. Intervention group: Group B will receive fractional CO۲ laser therapy with distilled water on one side and the combination of fractional CO۲ laser therapy and topical regular insulin on the other side. The mode of the fractional CO۲ device will be set to: Power: ۱۲, Stack:۲, Scanning dwell time: ۷۰۰, and Spacing: ۷۰۰. Severity of acne scar. Timepoint: At the beginning of the study and after two months. Method of measurement: Scale for Acne Scar Severity (SCAR-S),. Acne Scar Assessment Scale. Timepoint: At the beginning of the study and after two months. Method of measurement: Acne Scar Assessment Scale (ASAS). Grading of scar. Timepoint: At the beginning of the study and after two months. Method of measurement: Goodman and Baron quantitative global scarring grading system (GBAQGS). Dermatologic Life Quality Index. Timepoint: At the beginning of the study and after two months. Method of measurement: Dermatologic Life Quality Index (DLQI) questionnaire. Shiraz University of Medical Sciences Approved 2023-10-16 Ethics committee of Medical School of Shiraz University of Medical Sciences Medical School of Shiraz University of Medical Sciences Shiraz Fars Iran (Islamic Republic of)