NCT06509438

Effectiveness and Safety Evaluation of Embella (Deoxycholic Acid, by Espad Pharmed Co.) in Management of Submental Fat

Evaluating the Effectiveness and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) for the Management of Submental Fat

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Espad Pharmed · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Submental Fullness

Interventions

Type	Name	Description
DEVICE	Embella (Deoxycholic acid, produced by Espad Pharmed Co.)	2 milliliters of Embella injectable solution containing 20 milligrams of deoxycholic acid

Timeline

• Start date: 2023-04-10
• Primary completion: 2024-01-01
• Completion: 2024-01-01
• First posted: 2024-07-19
• Last updated: 2025-09-19
• Results posted: 2025-09-19

Locations

1 site across 1 country: Iran