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IRCT20190210042676N26 IRCT 2022-10-03 Parnian Gostar Radiometer Company Investigating the safety and efficacy of fractional microneedle Sophia device, in rejuvenating facial skin Investigating the safety and efficacy of fractional microneedle Sophia device, manufactured by Parnian Gostar Radiometer Company, in rejuvenating facial skin 2022-10-23 anticipated 21 Complete https://irct.ir/trial/65863 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Skin ageing. Intervention group: 4 sessions of full face treatment with fractional microneedle Sophia device, manufactured by Parnian Gostar Radiometer Company as a complete pass on full face. The diameter of the needles in this system is equal to 120μm.. 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 Aniseh Samadi
No. 415, Shahid Naderi (Soheil) St., Taleqani Ave.
Tehran Iran (Islamic Republic of) 1416613675 +98 21 8896 0880 aniseh_samadi@yahoo.com Tehran University of Medical Sciences scientific Alireza Firooz
No. 415, Shahid Naderi (Soheil) St., Taleqani Ave.
Tehran Iran (Islamic Republic of) 1416613675 +98 21 8897 7921 firozali@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Ages 30 to 60 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 consent form for participation in the study 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 Treatment - Devices Intervention group: 4 sessions of full face treatment with fractional microneedle Sophia device, manufactured by Parnian Gostar Radiometer Company as a complete pass on full face. The diameter of the needles in this system is equal to 120μm. Facial skin wrinkle grading, using Glogau scale. Timepoint: Before intervention, 4 and 8 weeks after last treatment session. Method of measurement: An independent dermatologist perform evaluation and scoring with the help of full face photos based on the percentage of improvement in facial wrinkles, using scale 1 to 4 (1 = no wrinkle 2 = Wrinkles in motion 3 = Wrinkles at rest 4 = Only wrinkles) . Skin thickness and density. Timepoint: Before intervention, 4 and 8 weeks after last treatment session. Method of measurement: Skin ultrasound. Area and volume of nasolabial fold. Timepoint: Before intervention, 4 and 8 weeks after last treatment session. Method of measurement: VisioFace camera. Parnian Gostar Radiometer Company Approved 2022-09-10 Ethics committee of 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)