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IRCT20150101020514N11 IRCT 2021-03-17 Zist orchid pharmed Company Safety and effectiveness of Lunafill Ultra intradermal injectable gel for correcting nasolabial folds Safety and effectiveness assessment of Lunafill Ultra intradermal injectable gel containing hyaluronic acid ( 24mg/ml) and lidocaine 0.3% for correcting nasolabial folds. Phase II, before after clinical study 2021-04-05 anticipated 30 Complete https://irct.ir/trial/55042 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 Lunafill ultra intradermal 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 (pH 7.2), 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 Signing the infirmed consent form 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 Allergy or sensitivity to lidocaine, hyaluronic acid products Active inflammation, infection, cancerous or pre-cancerous lesion or unhealed wound in the NLF region Current treatment with anti-coagulation therapy or use of non-steroidal anti-inflammatory drugs or other substances known to increase coagulation time within 10 days of undergoing study injections People prone to hypertrophic scar formation History of ant auto immune or immune deficiency diseases or using any immune suppressive drug Pregnancy and breast feeding Treatment - Devices Intervention group: one injection with 1-2 cc Lunafill ultra intradermal 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 (pH 7.2), 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 phot numeric 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 2021-03-15 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)