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IRCT20190210042676N29 IRCT 2023-02-14 Zist orchid pharmed Company Evaluation of an injectable solution with the brand name ®Embella in order to reduce submental fat. Evaluation of safety and effectiveness of an injectable solution containing deoxycholic acid with the brand name ®Embella, in order to reduce submental fat. 2023-02-20 anticipated 20 Complete https://irct.ir/trial/68119 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Submental fat. Intervention group: At least one and maximum of 3 sessions of treatment with 2 ml of Embella® injectable solution contains 20 mg deoxycholic acid with a minimum interval of 4 weeks. The product is 2 ml of sterilization transparent and colorless vials free of visible particles containing 20 mg deoxycholic acid. Other compounds include hyaluronic acid, injectable water, sodium chloride, sodium hydroxide, hydrochloric acid and anhydrous disodium phosphate.. 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 further 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 Mansour Nassiri Kashani
No. 415, Shahid Naderi (Soheil) Street, Taleqani Avenue
Tehran Iran (Islamic Republic of) 1416613675 +98 21 8897 7921 mnassirik@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Ages 18 to 65 People with unwanted submental fat with moderate to severe intensity, grades 2 and 3 of the clinical grade of SMF (submental fat) evaluation Have signed the informed consent form and agree to a 3-month follow-up. 18 years 65 years Both Any previous intervention to treat submental fat. Specific anatomical features or previous damage to the intervention site (ulcers, liposuction, difficulty swallowing, enlargement of the thyroid gland or lymph nodes) that interfere with the evaluation of intervention results. History of dysphagia Treatment - Drugs Intervention group: At least one and maximum of 3 sessions of treatment with 2 ml of Embella® injectable solution contains 20 mg deoxycholic acid with a minimum interval of 4 weeks. The product is 2 ml of sterilization transparent and colorless vials free of visible particles containing 20 mg deoxycholic acid. Other compounds include hyaluronic acid, injectable water, sodium chloride, sodium hydroxide, hydrochloric acid and anhydrous disodium phosphate. Grading changes in submental fat. Timepoint: Before intervention, 4 and 2 weeks after last injection. Method of measurement: Standard grading evaluation of submental fat (SMF). Change in fat diameter of submental area. Timepoint: Before intervention, 4 and 2 weeks after last injection. Method of measurement: Caliper. Consumer Satisfaction. Timepoint: Before intervention, 4 and 2 weeks after last injection. Method of measurement: Using the Likert scale includes: 0 = not satisfied at all, 1 = slightly satisfied, 2 = moderately satisfied, and 3 = very or extremely satisfied. Zist orchid pharmed Company Approved 2023-01-17 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)