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OpenTrials
Completed

NCT Number: NCT06509438

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

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Key information

Conditions

Submental Fullness

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Research and Training in Skin Diseases and Leprosy

Tehran, 1416613675, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

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

Primary outcomes

  1. Number of Participants With A Minimum of One Grade Improvement in the Standard Submental Fat (SMF) Assessment Grading

    Time frame: Week 4 after the last injection, up to 12 weeks, and week 12 after the last injection, up to 20 weeks

    The scales are from 0 to 4, 0 indicating no localized submental fat and 4 indicating extreme submental convexity

Secondary outcomes

  1. Measurement of Submental Fat Thickness

    Time frame: Week 4 after the last injection, up to 12 weeks, and week 12 after the last injection, up to 20 weeks

    Using calipers

  2. Pain Intensity Was Assessed Using the VAS From 0 to 10

    Time frame: Day 1, week 4 and week 8

    Visual Analogue Scale (VAS): pain intensity scale where 0 indicates no pain and 10 indicates the maximum pain imaginable

  3. Subject Satisfaction Was Assessed Using the VAS From 0 to 10

    Time frame: Week 4 after the last injection, up to 12 weeks, and week 12 after the last injection, up to 20 weeks

    Visual Analogue Scale (VAS): satisfaction factor scale where 0 indicates complete dissatisfaction and 10 indicates maximum satisfaction

  4. Number of Participants With Adverse Events Immediately After the Injections and During the Study Period

    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

    Safety assessment: number of participants with adverse events

Sponsors and collaborators

Lead sponsor

Espad Pharmed

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 19, 2024
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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