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

NCT06509438 | Completed Results

• 1 other identifier: EMB.ESP.AF. IV.01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Measurement of Submental Fat Thickness

  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

  Day 1, week 4 and week 8

• Subject Satisfaction Was Assessed Using the VAS From 0 to 10

  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

  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

Study Arms (1)

Embella (Deoxycholic acid, produced by Espad Pharmed Co.)

EXPERIMENTAL

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.)

Interventions

Embella (Deoxycholic acid, produced by Espad Pharmed Co.) DEVICE

2 milliliters of Embella injectable solution containing 20 milligrams of deoxycholic acid

Embella (Deoxycholic acid, produced by Espad Pharmed Co.)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Espad Pharmed: lead

Study Sites (1)

Center for Research and Training in Skin Diseases and Leprosy

Tehran, 1416613675, Iran

Location

Results Point of Contact

• Title: Hamidreza Kafi
• Organization: EspadPharmed

Kafi.h@orchidpharmed.com

+989129232594

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: before/after clinical trial

Study Record Dates

• First Submitted: July 13, 2024
• First Posted: July 19, 2024
• Study Start: April 10, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: September 19, 2025
• Results First Posted: September 19, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)