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IRCT20200127046282N25 IRCT 2023-02-18 Tehran University of Medical Sciences Evaluation of liposomal formulations of amniotic membrane in treatment skin aging after laser rejuvenation Evaluation of safety and effectiveness of liposomal formulations of amniotic membrane in treatment skin aging after laser rejuvenation (phase I / II clinical trial) 2023-02-20 anticipated 20 Complete https://irct.ir/trial/66792 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The data analyst will be blinded and will not know the control and treatment groups. The patient will not be aware of being in the control and test groups, and the product of each group will be used in the same form. 1-2 skin aging. Intervention 1: Control group: 10 patients use Amnion's non-liposomal product (Zist Sakht Bonyan Pars company) topically immediately after fractional CO2 laser rejuvenation in three sessions with an interval of one month. Intervention 2: Intervention group: 10 patients use amnion liposomal product (Zist Sakht Bonyan Pars company) topically immediately after fractional CO2 laser rejuvenation in three sessions with an interval of one month. 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 -
public sona zare
No. 4, Maryam Alley, South Kamraniye St.
Tehran Iran (Islamic Republic of) 1937957511 +98 21 2665 7438 sonazarebio@gmail.com Tehran University of Medical Sciences scientific Mohammad Ali Nilforoushzadeh
No. 4, Maryam Alley, South Kamraniye St.
Tehran Iran (Islamic Republic of) 1937957511 +98 21 2665 7438 Dr_nilforoush@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age between 20-60 Having middle wrinkles in face region 20 years 60 years Both Pregnancy and breastfeeding History of cancer Patients with a new history of gel and Botox injections People with Mental Disorders Active infection in the face L90.9 Atrophic disorder of skin, unspecified Treatment - Other Treatment - Other Control group: 10 patients use Amnion's non-liposomal product (Zist Sakht Bonyan Pars company) topically immediately after fractional CO2 laser rejuvenation in three sessions with an interval of one month. Intervention group: 10 patients use amnion liposomal product (Zist Sakht Bonyan Pars company) topically immediately after fractional CO2 laser rejuvenation in three sessions with an interval of one month. The amount of wrinkles. Timepoint: Before treatment and six month after the last session. Method of measurement: Visio face. Inflammation. Timepoint: After each session of treatment. Method of measurement: Questionnaire and visit. Intensity of pain. Timepoint: Treatment time. Method of measurement: Questionnaire and visit. Tehran University of Medical Sciences Approved 2022-10-10 Research Ethics Committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Keshavarz blvd Tehran Tehran Iran (Islamic Republic of)