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IRCT20150101020514N27 IRCT 2024-01-24 ESpadpharmed company Clinical study to evaluate the safety and efficacy of Intella dermal filler for correction of nasolabial folds A single-arm, before- after clinical study to evaluate the safety and efficacy of Intella dermal filler (produced by Espad Pharmed Darou Co.) for correction of moderate to severe nasolabial folds 2024-01-21 anticipated 30 Complete https://irct.ir/trial/74627 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Skin aging. Intervention group: One injection with 1-2 ml Intella brand gel produced by Espad Pharmed company in each nasolabial folds. Intella is a pyrogen-free, viscous, opaque, injectable, semi-solid, latex-free and biodegradable dermal filler gel. Ingredients: calcium hydroxyapatite microspheres with a diameter of 25-45 microns (55.7%), cross-linked sodium hyaluronate gel (20 mg per ml), lidocaine hydrochloride (3 mg per ml), phosphate buffer. 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 reaction Previous hyaluronic acid-based dermal filler injected within the last 12 months prior to enrollment. History of hypertrophic and keloid scars or bleeding disorders in the nasolabial region Active inflammatory processes, infection, lesions (cancerous/non-cancerous) in the nasolabial region History of autoimmune diseases/immune deficiency or use of immunosuppressive medicines during the 6 months before entering the study or during the study Pregnancy or lactation Treatment - Drugs Intervention group: One injection with 1-2 ml Intella brand gel produced by Espad Pharmed company in each nasolabial folds. Intella is a pyrogen-free, viscous, opaque, injectable, semi-solid, latex-free and biodegradable dermal filler gel. Ingredients: calcium hydroxyapatite microspheres with a diameter of 25-45 microns (55.7%), cross-linked sodium hyaluronate gel (20 mg per ml), lidocaine hydrochloride (3 mg per ml), phosphate buffer Severity of nasolabial folds. Timepoint: Before intervention and right after intervention and 2, 4, 12 and 24 weeks later. Method of measurement: 5 scale Allergan photo numeric grading. Number of people with at least one grade of reduction in the severity of both nasolabial folds. Timepoint: Before intervention and 3 and 6 months later. Method of measurement: scale Allergan photo numeric grading. Depth, area and volume of nasolabial fold. Timepoint: Before intervention ,1 ,3 and 6 months later. Method of measurement: Visioface camera. Thickness and density of dermis. Timepoint: Before intervention ,1 and 6 months later. Method of measurement: Skin ultrasound. ESpadpharmed company Approved 2024-01-02 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)