CompletedNot Applicable

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

Iran20 participantsStarted 2023-04-10

Plain-language 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

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT06509438

SponsorEspad Pharmed

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-01

Results submitted2025-08-05

View on ClinicalTrials.gov More Submental Fullness trials