Status:
COMPLETED
Effectiveness and Safety Evaluation of Embella (Deoxycholic Acid, by Espad Pharmed Co.) in Management of Submental Fat
Lead Sponsor:
Espad Pharmed
Conditions:
Submental Fullness
Eligibility:
All Genders
18-65 years
Phase:
NA
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 trea...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06509438
Start Date
April 10 2023
End Date
January 1 2024
Last Update
September 19 2025
Active Locations (1)
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1
Center for Research and Training in Skin Diseases and Leprosy
Tehran, Iran, 1416613675