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IRCT20150101020514N17 IRCT 2022-12-06 Zist orchid pharmed Company Safety and efficacy assessment of injectable gel with Perleux® brand, in order to rejuvenate facial skin Safety and efficacy assessment of injectable gel containing stabilized hyaluronic acid with Perleux® brand, in order to rejuvenate and improve facial skin elasticity and hydration 2022-12-22 anticipated 20 Complete https://irct.ir/trial/67059 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Skin Hydration. Intervention group: One injection with 2 ccstabilized hyaluronic acid with Perleux® brand. The product is 2cc prefilled sterilized syringe containing: 32 mg Hyaluronic Acid with high molecular weight+ 32 mg Hyaluronic Acid with low molecular weight from sodium hyaluronic acid salt in 2 ml soluble physiological buffer sodium chloride.. 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 more information
public Aniseh Samadi
No. 415, Taleqani Ave.
Tehran Iran (Islamic Republic of) 1416613675 +98 21 8897 2220 dermalab@tums.ac.ir Tehran University of Medical Sciences scientific Alireza Firooz
No 415, Taleqani St.
Tehran Iran (Islamic Republic of) 1416613675 +98 21 8897 2220 firozali@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 35 -60 years old men and women The presence of visible signs of skin aging mainly dry skin, skin roughness, loss of elasticity and clear lines and wrinkles. Have signed the informed consent form and agree to a 6-month follow-up 35 years 60 years Both Previous hyaluronic acid (HA)-based dermal filler treatment(s) injected within the last 12 months prior to enrollment History of radiofrequency (R-F), rejuvenation lasers or intense pulsed light in the past 6 months Pregnancy or lactation Treatment - Drugs Intervention group: One injection with 2 ccstabilized hyaluronic acid with Perleux® brand. The product is 2cc prefilled sterilized syringe containing: 32 mg Hyaluronic Acid with high molecular weight+ 32 mg Hyaluronic Acid with low molecular weight from sodium hyaluronic acid salt in 2 ml soluble physiological buffer sodium chloride. Skin elasticity (R0, R2, R5) measured in right cheek. Timepoint: Before intervention, 8 and 16 weeks later. Method of measurement: By cutometer probe of MPA 580(Multi Probe Adaptor) device. Thickness and density of dermis. Timepoint: Before intervention, 8 and 16 weeks later. Method of measurement: Skin ultrasound. Trans Epidermal Water Lost (TEWL) measured in right cheek. Timepoint: Before intervention, 8 and 16 weeks later. Method of measurement: By TEWA probe of MPA 580(Multi Probe Adaptor) device. Zist orchid pharmed Company Approved 2022-11-26 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)