N/A
N=20
Effectiveness and Safety Evaluation of Embella (Deoxycholic Acid, by Espad Pharmed Co.) in Management of Submental Fat
Submental Fullness
Bottom Line
View on ClinicalTrials.gov: NCT06509438 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Number of Participants With A Minimum of One Grade Improvement in the Standard Submental Fat (SMF) Assessment Grading — 15; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Embella (Deoxycholic acid, produced by Espad Pharmed Co.) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Espad Pharmed
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With A Minimum of One Grade Improvement in the Standard Submental Fat (SMF) Assessment Grading |
15; 10 | — |
| SECONDARY Measurement of Submental Fat Thickness |
1.85; 1.40; 1.45 | <0.001 sig |
| SECONDARY Pain Intensity Was Assessed Using the VAS From 0 to 10 |
5.1; 3.9; 3.0 | — |
| SECONDARY Subject Satisfaction Was Assessed Using the VAS From 0 to 10 |
7.63; 7.43 | — |
| SECONDARY Number of Participants With Adverse Events Immediately After the Injections and During the Study Period |
18 | — |
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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06509438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.