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IRCT20220723055530N1 IRCT 2022-07-27 Khosro Medisa Teb Company Assessment of the Results of Inovo Sense Smile and Inovo Sense Style Filler Injections to Correction Nasolabial Folds Evaluation of the Safety and Effectiveness of Inovo Sense Smile and Inovo Sense Style Intradermal Injectable Gel for Correcting Moderate to Severe Nasolabial Folds 2022-07-26 anticipated 30 Complete https://irct.ir/trial/64907 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Skin aging. Injection of Inovo Sense Smile and Inovo Sense Style Intradermal gel in the nasolabial folds, the products are in the 1 ml prefilled sterilized syringe containing: Inovo Sense Smile:Hyaluronic Acid gel 20 mg; Lidocaine hydrochloride, 0.3% ; Phosphate buffer (pH 7), 1 mlInovo Sense Style:Hyaluronic Acid gel, 23 mg; Lidocaine hydrochloride, 0.3% ; Phosphate buffer (pH 7), 1 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 further information
public Zeynab Aryanian
Vahdat Eslami Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5563 0223 zeinabaryanian@gmail.com Tehran University of Medical Sciences scientific Amirhooshang Ehsani
Vahdat Eslami Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5563 0223 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 Injection of Inovo Sense Smile and Inovo Sense Style Intradermal gel in the nasolabial folds, the products are in the 1 ml prefilled sterilized syringe containing: Inovo Sense Smile:Hyaluronic Acid gel 20 mg; Lidocaine hydrochloride, 0.3% ; Phosphate buffer (pH 7), 1 mlInovo Sense Style:Hyaluronic Acid gel, 23 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: 5-point photonumeric Allergan scale. Depth, area and volume of nasolabial folds. Timepoint: Before the intervention, immediately after that, 2 weeks, and 3 months later. Method of measurement: Visioface camera. Khosro Medisa Teb Company Approved 2022-04-20 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)