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IRCT20220723055530N3 IRCT 2024-01-06 Nik Sina Eksir Assessment of the Results of Medivim Filler Injections to Correction Nasolabial Folds Evaluation of efficacy and safety of "MediVim" HA dermal fillers in correction of moderate-to-severe Nasolabial folds 2024-01-07 anticipated 33 Complete https://irct.ir/trial/74619 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Skin aging. Intervention group: Injection of Medivim Intradermal filler in the nasolabial folds, the products are in the 1 ml pre-filled sterilized syringe containing:Medivim:Hyaluronic Acid gel 24 mg; Lidocaine hydrochloride, 0.3% ; Phosphate buffer (pH 7), 1 ml. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Maryam Nasimi
Razi hospital, Vahdat Eslami Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5563 0705 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 0705 ehsanih@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 30 -65 Years old men and women with moderate to severe nasolabial folds Signing the informed consent form 30 years 65 years Both History of a cosmetic procedure in the lower 2/3 of the face during the last three months Previous allergy to Hyaluronic Acid or Lidocaine Presence of inflammation, active infection, unhealed old wound, and skin lesions in the NLF region People prone to hypertrophic scar formation History of autoimmune or immune deficiency diseases Pregnancy or breastfeeding Treatment - Devices Intervention group: Injection of Medivim Intradermal filler in the nasolabial folds, the products are in the 1 ml pre-filled sterilized syringe containing:Medivim:Hyaluronic Acid gel 24 mg; Lidocaine hydrochloride, 0.3% ; Phosphate buffer (pH 7), 1 ml Severity of nasolabial folds. Timepoint: Before intervention, immediately after that, 2 weeks, and 3 months later. Method of measurement: Five-point photonumeric Allergan scale. Area, depth, and volume of nasolabial folds. Timepoint: Before the intervention, immediately after that, 2 weeks, and 3 months later. Method of measurement: Visioface camera. Nik Sina Eksir Approved 2023-12-26 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)