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

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 Overview

• Status: Completed
• Conditions: Submental Fullness
• Intervention / Treatment: Device: Embella (Deoxycholic acid, produced by Espad Pharmed Co.)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran
  • Tehran, Iran, 1416613675
    • Center for Research and Training in Skin Diseases and Leprosy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 18 and 65 years.
• Individuals with unwanted submental fat of any severity.
• Ability to comply with visit schedules and study procedures.
• Signed informed consent form and agreement to a 3-month follow-up.

Exclusion Criteria:

• Any previous intervention for the treatment of submental fat (SMF).
• Specific anatomical features or previous damage to the intervention site (e.g., scars, liposuction, swallowing difficulties, enlarged thyroid or lymph nodes) that could interfere with the assessment of intervention outcomes.
• Evidence of submental enlargement due to reasons other than SMF.
• History of dysphagia.
• Body mass index (BMI) > 30 kg/m².
• Individuals currently on a weight loss program.
• History of allergy to any components of the drug or local anesthetics.
• Presence of any inflammation, active infection, unhealed wounds, or skin lesions in the injection area.
• Use of any anticoagulants, NSAIDs, or any other medications that increase the risk of coagulation disorders within 7 days before injection.
• Unrealistic expectations.
• Pregnant or breastfeeding women.
• Individuals on sodium-restricted diets, such as those with uncontrolled hypertension.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Embella (Deoxycholic acid, produced by Espad Pharmed Co.); The intervention included a minimum of one and a maximum of three treatment sessions, of 2 milliliters of Embella (Deoxycholic acid, produced by Espad Pharmed Co.) injectable solution containing 20 milligrams of deoxycholic acid per session, spaced at least 4 weeks apart.	Device: Embella (Deoxycholic acid, produced by Espad Pharmed Co.); 2 milliliters of Embella injectable solution containing 20 milligrams of deoxycholic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Week 4 after the last injection, up to 12 weeks, and week 12 after the last injection, up to 20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Submental Fat Thickness	Using calipers	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	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	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	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

Collaborators and Investigators

• Sponsor: Espad Pharmed

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2023
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: July 13, 2024
• First Submitted That Met QC Criteria: July 13, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: August 30, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cholagogues and Choleretics; Deoxycholic Acid
• Other Study ID Numbers: EMB.ESP.AF. IV.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No