Submental fat (SMF) is a factor affecting beauty that makes people feel uncomfortable about themselves. In 2015, deoxycholic acid with the brand name KYBELLA® was approved by the American FDA for treatment of submental fat. The purpose of this study is to evaluate the safety and effectiveness of deoxycholic acid injection with the brand name Embella®, manufactured by Espad Pharmed Company, for treatment of this condition. Research Objectives Primary objective: Effectiveness and safety of Embella® in reducing submental fat Secondary objective: Effectiveness assessment of Embella® in improving SMF grading Effectiveness assessment of Embella® in reducing submental fat diameter
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
2 milliliters of Embella injectable solution containing 20 milligrams of deoxycholic acid
Center for Research and Training in Skin Diseases and Leprosy
Tehran, Iran
Number of Participants With A Minimum of One Grade Improvement in the Standard Submental Fat (SMF) Assessment Grading
The scales are from 0 to 4, 0 indicating no localized submental fat and 4 indicating extreme submental convexity
Time frame: Week 4 after the last injection, up to 12 weeks, and week 12 after the last injection, up to 20 weeks
Measurement of Submental Fat Thickness
Using calipers
Time frame: Week 4 after the last injection, up to 12 weeks, and week 12 after the last injection, up to 20 weeks
Pain Intensity Was Assessed Using the VAS From 0 to 10
Visual Analogue Scale (VAS): pain intensity scale where 0 indicates no pain and 10 indicates the maximum pain imaginable
Time frame: Day 1, week 4 and week 8
Subject Satisfaction Was Assessed Using the VAS From 0 to 10
Visual Analogue Scale (VAS): satisfaction factor scale where 0 indicates complete dissatisfaction and 10 indicates maximum satisfaction
Time frame: Week 4 after the last injection, up to 12 weeks, and week 12 after the last injection, up to 20 weeks
Number of Participants With Adverse Events Immediately After the Injections and During the Study Period
Safety assessment: number of participants with adverse events
Time frame: Immediately after all of the injections and at week 4 after the last injection, up to 12 weeks, and week 12 after the last injection, up to 20 weeks
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