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IRCT20250308064973N1 IRCT 2025-03-21 Medisa Ara Gostar Iranian company Evaluation of safety and efficacy of INOVOSENSE MESOCELL PLUS mesogel for improvement of face skin elasticity and rejuvenation Evaluation of safety and efficacy of INOVOSENSE MESOCELL PLUS mesogel for improvement of face skin elasticity and rejuvenation 2025-03-10 anticipated 20 Complete https://irct.ir/trial/82313 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Skin aging. Intervention group: INOVOSENSE MESOCELL PLUS mesogel injection for improvement of face skin elasticity and rejuvenation. the products are in the 2 ml prefilled sterilized syringe, which contains: Polydeoxyribonucleotide 40 mg, Lidocaine hydrochloride 0.25 % and Phosphate Buffer pH 7 q.s.: 2 ml. 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 Maryam Nasimi
Vahdat Eslami Square, Tehran, Iran
tehran Iran (Islamic Republic of) 1199663911 +98 21 5563 0223 nsm.maryam@gmail.com Tehran University of Medical Sciences scientific Amirhooshang Ehsani
Razi Hospital, Vahdat Eslami Square, Tehran, Iran
tehran Iran (Islamic Republic of) 1199663911 +98 21 5563 0223 ehsanih@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 25 - 60 Years women and men Signs of skin aging, such as reduced skin elasticity and the presence of lines and wrinkles on the face 25 years 60 years Both Any cosmetic facial procedures during the last 6 months Autoimmune or immune deficiency diseases Patients with epilepsy and malignant tumors History of allergic diseases Presence of granulomas associated with sarcoidosis and Osler's nodes in endocarditis Taking medications such as NSAIDs, platelet aggregation inhibitors, anticoagulants, and immunosuppressants Active inflammation or infection Allergy to polydeoxyribonucleotides or lidocaine Pregnancy and breastfeeding Treatment - Devices Intervention group: INOVOSENSE MESOCELL PLUS mesogel injection for improvement of face skin elasticity and rejuvenation. the products are in the 2 ml prefilled sterilized syringe, which contains: Polydeoxyribonucleotide 40 mg, Lidocaine hydrochloride 0.25 % and Phosphate Buffer pH 7 q.s.: 2 ml Facial skin elasticity. Timepoint: Before the intervention and 4 weeks after the last injection. Method of measurement: cutometery. Side effects. Timepoint: Before the intervention and 4 weeks after the last injection. Method of measurement: Based on patient's comments. Signs of skin aging include lines and wrinkles. Timepoint: Before the intervention and 4 weeks after the last injection. Method of measurement: GAIS scale. Medisa Ara Gostar Iranian company Approved 2025-03-04 Ethics committee of Tehran University of Medical Sciences Room 105 , 5th floor, Central construction of Tehran University of Medical Sciences, Ghods intersection, Keshavarz blvd. tehran Tehran Iran (Islamic Republic of)