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IRCT20210130050179N4 IRCT 2022-09-18 Maya Slim Ariya Company Safety and efficacy evaluation of Ignite microknife device, made by Medaria company in rejuvenation and improvement of facial sagging symptoms Safety and efficacy evaluation of "facial microknife" and "microhook" of Ignite radio hybrid microknife device, made by Medaria company in rejuvenation and improvement of facial sagging symptoms 2022-09-23 anticipated 21 Complete https://irct.ir/trial/65686 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Skin aging. Intervention group: One session of full face treatment by "facial microknife" and "microhook" of Ignite radio hybrid microknife device, made by Medaria company. Microknife intervention is a complete pass with a facial microknife on the entire face (Its surface is 15 x 15 mm and it has 35 needles with a penetration depth of 2.5 to 3 mm) and a pass with a microhook is performed on the nasolabial folds (The needles are like hooks and are locked when entering the skin).. 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 Taraneh Yazdanparast
No. 415, Shahid Naderi (Soheil) Street, Taleqani Avenue
Tehran Iran (Islamic Republic of) 1416613675 +98 21 8896 0880 drtaraneh@yahoo.com Tehran University of Medical Sciences scientific Alireza Firooz
No. 415, Shahid Naderi (Soheil) Street, Taleqani Avenue
Tehran Iran (Islamic Republic of) 1416613675 +98 21 8897 7921 firozali@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) People aged between 30 to 60 years People with facial skin wrinkles grade 2 and 3 based on Glogau scale and mild to moderate sagging (1 and 2) based on the Modified Fitzpatrick Wrinkle Criteria Signing the informed consent form 30 years 60 years Both History of using any type of device filler, including silicone, fat, collagen, hyaluronic acid or artificial materials in the treatment area History of any type of cosmetic surgery during the last 3 years at the treatment area Use of Isotretinoin in the last 6 months Suffering from collagen vascular diseases, diabetes, severe heart diseases History of treatment by Radio Frequency (RF) during the last year Treatment - Devices Intervention group: One session of full face treatment by "facial microknife" and "microhook" of Ignite radio hybrid microknife device, made by Medaria company. Microknife intervention is a complete pass with a facial microknife on the entire face (Its surface is 15 x 15 mm and it has 35 needles with a penetration depth of 2.5 to 3 mm) and a pass with a microhook is performed on the nasolabial folds (The needles are like hooks and are locked when entering the skin). ّfacial skin wrinkle grading, using Glogau scale. Timepoint: Before intervention, 4 and 8 weeks after treatment. Method of measurement: One independent dermatologist will perform clinical assessments using patients’ photographs according to the Glogau scale. Facial skin sagging based on Modified Fitzpatrick Wrinkle Criteria. Timepoint: Before intervention, 4 and 8 weeks after treatment. Method of measurement: One independent dermatologist will perform clinical assessments using patients’ photographs according to the Modified Fitzpatrick wrinkle scale. Area and volume of nasolabial fold. Timepoint: Before intervention, 4 and 8 weeks after treatment. Method of measurement: VisioFace device. Skin thickness and density. Timepoint: Before intervention, 4 and 8 weeks after treatment. Method of measurement: Skin ultrasound. Maya Slim Ariya Company Approved 2022-08-30 Ethics committee in research of medical school-Tehran University of Medical Sciences Research and Technology Dept, 6th floor, Central Organization of the University, Ghods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)