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IRCT20150101020514N25 IRCT 2023-11-12 Atra Zist Arai Company Clinical evaluation of the efficacy and safety of Luxiva brand skin mesotherapy solution for rejuvenation of facial skin Clinical evaluation of the efficacy and safety of Luxiva brand skin mesotherapy solution for rejuvenation and improvement of facial skin elasticity and hydration 2023-11-22 anticipated 20 Complete https://irct.ir/trial/73438 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Skin hydration. Intervention group: 4 sessions with 4 cc sterile solution of Luxiva injection mesotherapy. The intervals for the first three injections are done at the beginning of every two weeks and the fourth injection, one month after the third injection. Luxiva injection solution is sterile and contains hyaluronic acid 20 mg/vial amino acid alanine, arginine, etc.. 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) Age between 35 and 60 years old Present visible signs of skin ageing symptoms mainly skin dryness skin roughness, loss of elasticity and appearance of fine lines Possibility to accompany the visit plans and study process. Signing an informed consent form and agreed to follow up. 35 years 60 years Both Previous treatment with hyaluronic acid fillers in the facial area within the past year Experience with RF, rejuvenation lasers or intense pulsed light in the past 6 months Systemic diseases affecting skin health such as collagen vascular diseases, diabetes, hypothyroidism, as well as liver and renal failure. History of systemic use of skin-related medicine such as glucocorticoids, isotretinoin, immunomodulators and hormonal medicine in the past 3 months Currently pregnant or lactating Smoking in the past two years Treatment - Drugs Intervention group: 4 sessions with 4 cc sterile solution of Luxiva injection mesotherapy. The intervals for the first three injections are done at the beginning of every two weeks and the fourth injection, one month after the third injection. Luxiva injection solution is sterile and contains hyaluronic acid 20 mg/vial amino acid alanine, arginine, etc. Skin elasticity. Timepoint: Before intervention, one month after the last injection (day 90) and 2 months after the last injection (day 120). Method of measurement: Cutometery. Stratum corneum hydration. Timepoint: Before intervention, one month after the last injection (day 90) and 2 months after the last injection (day 120). Method of measurement: Corneometry by MPA 580. Skin condition for signs of skin aging including clear lines and wrinkles. Timepoint: Before intervention, one month after the last injection (day 90) and 2 months after the last injection (day 120). Method of measurement: Using GAIS scale. Atra Zist Arai Company Approved 2023-11-11 Ethics committee of The Institute of Pharmaceutical Sciences of Tehran University of Medical Science Unit 1-219, 2nd floor, The Institute of Pharmaceutical Sciences, Faculty of Pharmacy, 16 Azar Avenue Tehran Tehran Iran (Islamic Republic of)