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IRCT20150101020514N26 IRCT 2023-11-12 Nano Darou Pajouhan Pardis Company evaluate the safety and efficacy of Inshape X® intradermal filler A single-arm, before- after clinical study to evaluate the safety and efficacy of Inshape X® intradermal filler containing 150mg poly-L-lactic acid (NanoDaru Pajuhan Pardis) for correction of moderate to severe nasolabial folds 2023-11-22 anticipated 30 Complete https://irct.ir/trial/73665 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Skin aging. Intervention group: receiving a subcutaneous dose of inshape-x-scalp suspension (poly-L-lactic acid of Pardis Nano Darou Pazhouhan Pharmaceutical Company) containing 150 mg, using one of the linear threading, Fanning, Serial puncture, and Cross hatch techniques, according to the researcher's opinion. Preparation of each vial is done using 8ml sterile water. In order to pain reduction, 1 ml of lidocaine 2% will be added to the prepared suspension before injection and the final suspension volume will be 9 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 Aniseh Samadi
No. 415, Shahid Naderi (Soheil) Street, Taleqani Avenue
Tehran Iran (Islamic Republic of) 1416613675 +98 21 8896 0880 aniseh_samadi@yahoo.com Tehran University of Medical Sciences scientific Alireza Firooz
No. 415, Shahid Naderi (Soheil) Street, Taleqani Avenue
Tehran Iran (Islamic Republic of) 1416613675 +98 21 8897 2220 firozali@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 18–65-year-old men and women Moderate to severe nasolabial folds based on Allergan criteria. The opportunity to accompany the visit programs and study process. Signing the informed consent form and agree to a 6-month follow-up. 18 years 65 years Both History of type 1 allergic reactions or anaphylaxis reactions Previous allergy to filler and lidocaine ingredients History of hypertrophic and colloid scars or bleeding disorders in the nasolabial region Active inflammatory processes, infection, lesion (cancerous/noncancerous) in the nasolabial region Pregnancy and lactation Treatment - Drugs Intervention group: receiving a subcutaneous dose of inshape-x-scalp suspension (poly-L-lactic acid of Pardis Nano Darou Pazhouhan Pharmaceutical Company) containing 150 mg, using one of the linear threading, Fanning, Serial puncture, and Cross hatch techniques, according to the researcher's opinion. Preparation of each vial is done using 8ml sterile water. In order to pain reduction, 1 ml of lidocaine 2% will be added to the prepared suspension before injection and the final suspension volume will be 9 ml. Severity of nasolabial folds. Timepoint: Before intervention and 4 weeks later. Method of measurement: 5 scale Allergan photo numeric grading. Severity of nasolabial folds. Timepoint: Before intervention, 3, 6 and 12 months later. Method of measurement: 5 scale Allergan photo numeric grading. Severity of nasolabial folds. Timepoint: Before intervention, 1, 3, 6 and 12 months later. Method of measurement: Based on GAIS scale compared to base mode. Depth, area and volume of nasolabial fold. Timepoint: Before intervention, 1, 6 and 12 months later. Method of measurement: Visioface camera. Nano Darou Pajouhan Pardis Company Approved 2023-11-10 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)