Submental FullnessNCT06509438
Effectiveness and Safety Evaluation of Embella (Deoxycholic Acid, by Espad Pharmed Co.) in Management of Submental Fat
A study testing Embella (Deoxycholic acid, produced by Espad Pharmed Co.) in people with Submental Fullness, run by Espad Pharmed at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Submental Fullness
- What is being tested?
- Embella (Deoxycholic acid, produced by Espad Pharmed Co.)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- 10 Apr 2023to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Center for Research and Training in Skin Diseases and Leprosy
Tehran, 1416613675
About this study
Official title: 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
- Conditions
- Submental Fullness
- Being tested
- Embella (Deoxycholic acid, produced by Espad Pharmed Co.)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embella (Deoxycholic acid, produced by Espad Pharmed Co.)Device
2 milliliters of Embella injectable solution containing 20 milligrams of deoxycholic acid
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Embella (Deoxycholic acid, produced by Espad Pharmed Co.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Using calipers
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start10 Apr 2023
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Submental FullnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- before/after clinical trial
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Espad Pharmed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509438
- Sponsor's protocol ID
- EMB.ESP.AF. IV.01
- Status last verified
- Jul 2024
- First submitted
- 13 Jul 2024
- Last updated
- 19 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) for the Management of Submental Fat
- ClinicalTrials.gov ID
- NCT06509438
- Acronym / sponsor ID
- EMB.ESP.AF. IV.01
- Conditions
- Submental Fullness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Espad PharmedIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 19 Jul 2024 (actual)
- Results
- Posted 19 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- before/after clinical trial
| Arm | Type | Receives |
|---|---|---|
| Embella (Deoxycholic acid, produced by Espad Pharmed Co.) | Experimental | Device: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Embella (Deoxycholic acid, produced by Espad Pharmed Co.)2 milliliters of Embella injectable solution containing 20 milligrams of deoxycholic acid | Device | Embella (Deoxycholic acid, produced by Espad Pharmed Co.) |
Primary outcome
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
4 secondary outcomes
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
Pain Intensity Was Assessed Using the VAS From 0 to 10
Time frame: Day 1, week 4 and week 8
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embella (Deoxycholic acid, produced by Espad Pharmed Co.) in people with Submental Fullness, run by Espad Pharmed at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.