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IRCT20140705018373N4 IRCT 2020-08-19 Tabriz University of Medical Sciences Effect of fat injection with and without SVF in the treatment of facial wrinklesAcronymemptyStudy Comparison of fat injection with and without stromal vascular fraction in the treatment of nasolabial and cheek wrinkles 2020-07-05 anticipated 20 Complete https://irct.ir/trial/49971 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done using the patient file number and using even and odd numbers. The criterion will be the last digit of the patient's file number and the number zero will be considered even. Evens will be considered as a study group and odd numbers as a control group, Blinding description: Patients will be blinded for the type of solution injected. 3 Nasolabial and cheek wrinkles. Intervention 1: Intervention group: Patients receive 5 ml of pure fat and 5 ml of svf (stromal vascular fraction) using needle number 27 within 7 minutes. Intervention 2: Control group: Patients receive 10 ml of pure fat using needle number 27 within 7 minutes. Yes - There is a plan to make this available What will be shared: There is a plan to make this avalable When: Study data is categorized and coded with no identifiable individuals. When the data will become available and for how long To whom: Access to study data after publication of the result is available in the journal. To whom data/document is available Conditions: Anyone interested in using the data can access the study data. Under which criteria data/document could be used Where to obtain: Study data can be used for comparison with other results. From where data/document is obtainable How to obtain: Refer to the study's scientific or public accountability person for data. Comments: The use request will be emailed to the scientific or public accountability person.
public Dr. Leila Asadi
Sina hospital, between Hafez and Shahid-Montazeri square, Azadi street
Tabriz Iran (Islamic Republic of) 5163639888 +98 41 3549 8236 Leilaasadi463@gmail.com Tabriz University of Medical Sciences scientific Dr. Mohammadreza Ranjkesh
Sina hospital, Azadi Ave., Tabriz town, East Azarbyjan
Tabriz Iran (Islamic Republic of) 5163639888 +98 41 3549 8236 ranjkeshm@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Age under 65 years old Patients satisfaction Middle to deep nasolabial wrinkles no limit 65 years Both Diabetes melitus Patients with hematologic and coagulation problems Smoking Pregnancy Use of Aspirin Patients with defective immune system Other and R23.8 Treatment - Drugs Treatment - Drugs Intervention group: Patients receive 5 ml of pure fat and 5 ml of svf (stromal vascular fraction) using needle number 27 within 7 minutes. Control group: Patients receive 10 ml of pure fat using needle number 27 within 7 minutes. Nasolabial and cheek wrinkle severity. Timepoint: Before injection, 3, 6 and 12 months after injection. Method of measurement: Wrinkle Severity Rating Scale. The degree of tissue healing and homogeneity of facial skin. Timepoint: Before injection, 3, 6 and 12 months after injection. Method of measurement: Skin Homogeneity and Texture ScaleI. Tabriz University of Medical Sciences Approved 2020-07-05 Ethics committee of Tabriz University of Medical Sciences Sina hospital, between Hafez and Shahid-Montazeri square, Azadi street Tabriz East Azarbaijan Iran (Islamic Republic of)