]>
IRCT20150101020514N12 IRCT 2021-06-29 Zist orchid pharmed Company Safety and effectiveness assessment of Fiorage L. gel for nasolabial folds correction Safety and effectiveness assessment of Fiorage L. gel produced by Orchid Pharmed company for nasolabial folds correction 2021-07-23 anticipated 30 Complete https://irct.ir/trial/56743 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Skin aging. Intervention group: one injection with 1-2 cc Fiorage L injectable gel in each nasolabial fold. The product is 1cc prefilled sterilized syringe containing: Hyaluronic Acid gel, 24 mg Lidocaine hydrochloride, 3 mg Phosphate buffer and mannitol (pH 7.2), up to 1 m.. 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, Taleqani Ave.
Tehran Iran (Islamic Republic of) 1416613675 +98 21 8897 2220 dermalab@tums.ac.ir Tehran University of Medical Sciences scientific Alireza Firooz
No 415, Taleqani St.
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 years old men and women Moderate to severe nasolabial folds based onAllergan criteria The opportunity to accompany the visit programs and study process. Signing the infirmed consent form and agree to a 6-month follow-up 18 years 65 years Both Previous hyaluronic acid (HA)-based dermal filler treatment(s) injected within the last 12 months prior to enrollment Cosmetic facial procedures (chemical peel, laser, radio frequency, dermabrasion, ablative or non-ablative procedures), Botox) in the lower 2/3 of the face, within 3 month prior to study entry Planning to undergo any of these procedures at any time during the study Treatment - Devices Intervention group: one injection with 1-2 cc Fiorage L injectable gel in each nasolabial fold. The product is 1cc prefilled sterilized syringe containing: Hyaluronic Acid gel, 24 mg Lidocaine hydrochloride, 3 mg Phosphate buffer and mannitol (pH 7.2), up to 1 m. Severity of nasolabial folds. Timepoint: Before intervention and right after that and 2 weeks, 3 and 6 months later. Method of measurement: 5 scale Allergan photonumeric grading. Depth, area and volume of nasolabial fold. Timepoint: Before intervention and right after that and 2 weeks, 3 and 6 months later. Method of measurement: Visioface camera. Thickness and density of dermis. Timepoint: Before intervention and 2 weeks and 6 months later. Method of measurement: Skin ultrasound. Zist orchid pharmed Company Approved 2021-06-20 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)